Trial Outcomes & Findings for Study of Safety, Reactogenicity and Immunogenicity of GlaxoSmithKline's (GSK)Respiratory Syncytial Virus (RSV)Maternal Unadjuvanted Vaccine in Healthy Pregnant Women (Aged 18 to 40 Years) and Their Infants (NCT NCT04126213)
NCT ID: NCT04126213
Last Updated: 2021-12-13
Results Overview
Assessed solicited administration site events were pain, erythema and swelling. Any = occurrence of the symptom regardless of intensity grade. Any erythema and swelling symptom = symptom reported with a surface diameter greater than 0 millimeters.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
534 participants
Primary outcome timeframe
During the 7-day follow-up period after vaccination (i.e. day of vaccination and 6 subsequent days)
Results posted on
2021-12-13
Participant Flow
Out of 534 participants who signed the informed consent 213 maternal subjects were vaccinated, and 206 infants were born to those exposed mothers. Therefore, a total of 419 are considered exposed.
Participant milestones
| Measure |
RSV MAT 60 Group-Mother
Maternal subjects randomized to RSV MAT 60 Group received a single dose of RSV MAT (60 µg) vaccine at Day 1, and were followed up until the study end.
|
RSV MAT 120 Group-Mother
Maternal subjects randomized to RSV MAT 120 group received a single dose of RSV MAT (120 µg) vaccine at Day 1, and were followed up until the study end.
|
Control Group-Mother
Maternal subjects randomized to the Control Group received a single dose of Placebo at Day 1, and were followed up until the study end.
|
RSV MAT 60 Group-Infant
This group consisted of infants born to mothers (from RSV MAT 60 Group-Mother) who received a single dose of RSV MAT (60 µg) vaccine during pregnancy.
|
RSV MAT 120 Group-Infant
This group consisted of infants born to mothers (from RSV MAT 120 Group-Mother) who received a single dose of RSV MAT (120 µg) vaccine during pregnancy.
|
Control Group-Infant
This group consisted of infants born to mothers (from Control Group-Mother) who received a single dose of placebo during pregnancy.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
70
|
75
|
68
|
67
|
73
|
66
|
|
Overall Study
COMPLETED
|
58
|
70
|
59
|
54
|
67
|
55
|
|
Overall Study
NOT COMPLETED
|
12
|
5
|
9
|
13
|
6
|
11
|
Reasons for withdrawal
| Measure |
RSV MAT 60 Group-Mother
Maternal subjects randomized to RSV MAT 60 Group received a single dose of RSV MAT (60 µg) vaccine at Day 1, and were followed up until the study end.
|
RSV MAT 120 Group-Mother
Maternal subjects randomized to RSV MAT 120 group received a single dose of RSV MAT (120 µg) vaccine at Day 1, and were followed up until the study end.
|
Control Group-Mother
Maternal subjects randomized to the Control Group received a single dose of Placebo at Day 1, and were followed up until the study end.
|
RSV MAT 60 Group-Infant
This group consisted of infants born to mothers (from RSV MAT 60 Group-Mother) who received a single dose of RSV MAT (60 µg) vaccine during pregnancy.
|
RSV MAT 120 Group-Infant
This group consisted of infants born to mothers (from RSV MAT 120 Group-Mother) who received a single dose of RSV MAT (120 µg) vaccine during pregnancy.
|
Control Group-Infant
This group consisted of infants born to mothers (from Control Group-Mother) who received a single dose of placebo during pregnancy.
|
|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
9
|
1
|
5
|
10
|
4
|
7
|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
1
|
1
|
1
|
1
|
|
Overall Study
Other
|
0
|
0
|
2
|
2
|
0
|
1
|
|
Overall Study
MIGRATED / MOVED FROM THE STUDY AREA
|
0
|
2
|
1
|
0
|
1
|
2
|
Baseline Characteristics
Study of Safety, Reactogenicity and Immunogenicity of GlaxoSmithKline's (GSK)Respiratory Syncytial Virus (RSV)Maternal Unadjuvanted Vaccine in Healthy Pregnant Women (Aged 18 to 40 Years) and Their Infants
Baseline characteristics by cohort
| Measure |
RSV MAT 60 Group-Mother
n=70 Participants
Maternal subjects randomized to RSV MAT 60 Group received a single dose of RSV MAT (60 µg) vaccine at Day 1, and were followed up until the study end.
|
RSV MAT 120 Group-Mother
n=75 Participants
Maternal subjects randomized to RSV MAT 120 group received a single dose of RSV MAT (120 µg) vaccine at Day 1, and were followed up until the study end.
|
Control Group-Mother
n=68 Participants
Maternal subjects randomized to the Control Group received a single dose of Placebo at Day 1, and were followed up until the study end.
|
RSV MAT 60 Group-Infant
n=67 Participants
This group consisted of infants born to mothers (from RSV MAT 60 Group-Mother) who received a single dose of RSV MAT (60 µg) vaccine during pregnancy.
|
RSV MAT 120 Group-Infant
n=73 Participants
This group consisted of infants born to mothers (from RSV MAT 120 Group-Mother) who received a single dose of RSV MAT (120 µg) vaccine during pregnancy.
|
Control Group-Infant
n=66 Participants
This group consisted of infants born to mothers (from Control Group-Mother) who received a single dose of placebo during pregnancy.
|
Total
n=419 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
43 Participants
n=21 Participants
|
29 Participants
n=10 Participants
|
111 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
AMERICAN INDIAN OR ALASKA NATIVE
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
ASIAN
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
BLACK OR AFRICAN AMERICAN
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
9 Participants
n=10 Participants
|
67 Participants
n=115 Participants
|
|
Age, Customized
0 to 1 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
67 Participants
n=4 Participants
|
73 Participants
n=21 Participants
|
66 Participants
n=10 Participants
|
206 Participants
n=115 Participants
|
|
Age, Customized
18 < 35 years
|
59 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
177 Participants
n=115 Participants
|
|
Age, Customized
>= 35 years
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
36 Participants
n=115 Participants
|
|
Sex: Female, Male
Female
|
70 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
37 Participants
n=10 Participants
|
308 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
10 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
OTHER
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
8 Participants
n=10 Participants
|
56 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
UNKNOWN
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
WHITE
|
45 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
49 Participants
n=21 Participants
|
46 Participants
n=10 Participants
|
275 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: During the 7-day follow-up period after vaccination (i.e. day of vaccination and 6 subsequent days)Population: The analysis was performed on the Solicited Safety Set (SSS), which included all the maternal subjects who received at least 1 dose of the study intervention and who had solicited safety data.
Assessed solicited administration site events were pain, erythema and swelling. Any = occurrence of the symptom regardless of intensity grade. Any erythema and swelling symptom = symptom reported with a surface diameter greater than 0 millimeters.
Outcome measures
| Measure |
RSV MAT 60 Group-Mother
n=70 Participants
Maternal subjects randomized to RSV MAT 60 Group received a single dose of RSV MAT (60 µg) vaccine at Day 1, and were followed up until the study end.
|
RSV MAT 120 Group-Mother
n=75 Participants
Maternal subjects randomized to RSV MAT 120 group received a single dose of RSV MAT (120 µg) vaccine at Day 1, and were followed up until the study end.
|
Control Group-Mother
n=66 Participants
Maternal subjects randomized to the Control Group received a single dose of Placebo at Day 1, and were followed up until the study end.
|
|---|---|---|---|
|
Percentage of Maternal Subjects With Any Solicited Administration Site Events
Any Pain
|
57.1 Percentage of maternal subjects
Interval 44.7 to 68.9
|
52 Percentage of maternal subjects
Interval 40.2 to 63.7
|
15.2 Percentage of maternal subjects
Interval 7.5 to 26.1
|
|
Percentage of Maternal Subjects With Any Solicited Administration Site Events
Any Erythema
|
1.4 Percentage of maternal subjects
Interval 0.0 to 7.7
|
6.7 Percentage of maternal subjects
Interval 2.2 to 14.9
|
0 Percentage of maternal subjects
Interval 0.0 to 5.4
|
|
Percentage of Maternal Subjects With Any Solicited Administration Site Events
Any Swelling
|
4.3 Percentage of maternal subjects
Interval 0.9 to 12.0
|
4 Percentage of maternal subjects
Interval 0.8 to 11.2
|
0 Percentage of maternal subjects
Interval 0.0 to 5.4
|
PRIMARY outcome
Timeframe: During the 7-day follow-up period after vaccination (i.e. day of vaccination and 6 subsequent days)Population: The analysis was performed on the SSS, which included all the maternal subjects who received at least 1 dose of the study intervention and who had solicited safety data.
Assessed solicited systemic events were fatigue, headache, nausea, vomiting, diarrhea, abdominal pain and fever \[temperature equal to or above (≥) 38 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade or relation to study intervention.
Outcome measures
| Measure |
RSV MAT 60 Group-Mother
n=70 Participants
Maternal subjects randomized to RSV MAT 60 Group received a single dose of RSV MAT (60 µg) vaccine at Day 1, and were followed up until the study end.
|
RSV MAT 120 Group-Mother
n=75 Participants
Maternal subjects randomized to RSV MAT 120 group received a single dose of RSV MAT (120 µg) vaccine at Day 1, and were followed up until the study end.
|
Control Group-Mother
n=66 Participants
Maternal subjects randomized to the Control Group received a single dose of Placebo at Day 1, and were followed up until the study end.
|
|---|---|---|---|
|
Percentage of Maternal Subjects With Any Solicited Systemic Events
Any Fever
|
0 Percentage of maternal subjects
Interval 0.0 to 5.1
|
0 Percentage of maternal subjects
Interval 0.0 to 4.8
|
0 Percentage of maternal subjects
Interval 0.0 to 5.4
|
|
Percentage of Maternal Subjects With Any Solicited Systemic Events
Any Fatigue
|
40 Percentage of maternal subjects
Interval 28.5 to 52.4
|
34.7 Percentage of maternal subjects
Interval 24.0 to 46.5
|
25.8 Percentage of maternal subjects
Interval 15.8 to 38.0
|
|
Percentage of Maternal Subjects With Any Solicited Systemic Events
Any Headache
|
34.3 Percentage of maternal subjects
Interval 23.3 to 46.6
|
28 Percentage of maternal subjects
Interval 18.2 to 39.6
|
19.7 Percentage of maternal subjects
Interval 10.9 to 31.3
|
|
Percentage of Maternal Subjects With Any Solicited Systemic Events
Any Nausea
|
25.7 Percentage of maternal subjects
Interval 16.0 to 37.6
|
22.7 Percentage of maternal subjects
Interval 13.8 to 33.8
|
13.6 Percentage of maternal subjects
Interval 6.4 to 24.3
|
|
Percentage of Maternal Subjects With Any Solicited Systemic Events
Any Vomiting
|
7.1 Percentage of maternal subjects
Interval 2.4 to 15.9
|
9.3 Percentage of maternal subjects
Interval 3.8 to 18.3
|
4.5 Percentage of maternal subjects
Interval 0.9 to 12.7
|
|
Percentage of Maternal Subjects With Any Solicited Systemic Events
Any Diarrhea
|
14.3 Percentage of maternal subjects
Interval 7.1 to 24.7
|
17.3 Percentage of maternal subjects
Interval 9.6 to 27.8
|
13.6 Percentage of maternal subjects
Interval 6.4 to 24.3
|
|
Percentage of Maternal Subjects With Any Solicited Systemic Events
Any Abdominal pain
|
12.9 Percentage of maternal subjects
Interval 6.1 to 23.0
|
22.7 Percentage of maternal subjects
Interval 13.8 to 33.8
|
9.1 Percentage of maternal subjects
Interval 3.4 to 18.7
|
PRIMARY outcome
Timeframe: At Day 8Population: The analysis was performed on the Exposed Set-Maternal (ESM), which included all the maternal subjects who received at least 1 dose of study intervention.
Hematological parameters assessed were Eosinophils (EOS), Erythrocytes (ERY), Hematocrit (HEM), Lymphocytes (LYMP), Mean Corpuscular Volume (MCV), Neutrophils (NEU), Platelets (PLA), and White Blood Cells (WBC) count. The increase and/or decrease of these parameters were evaluated at Day 8. Abnormal laboratory values refer to range indicator at Day 8 (D8) categorized as Missing, Below, Within and Above normal values and compared to the baseline (B) range indicator of the same parameter, at Screening (up to 15 days before vaccination) i.e. Missing, Below, Within and Above. E.g. 'WBC decrease Below (B) - Within (D8)' = WBC decrease in subjects with below normal values at baseline and within normal values at Day 8.
Outcome measures
| Measure |
RSV MAT 60 Group-Mother
n=70 Participants
Maternal subjects randomized to RSV MAT 60 Group received a single dose of RSV MAT (60 µg) vaccine at Day 1, and were followed up until the study end.
|
RSV MAT 120 Group-Mother
n=75 Participants
Maternal subjects randomized to RSV MAT 120 group received a single dose of RSV MAT (120 µg) vaccine at Day 1, and were followed up until the study end.
|
Control Group-Mother
n=68 Participants
Maternal subjects randomized to the Control Group received a single dose of Placebo at Day 1, and were followed up until the study end.
|
|---|---|---|---|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
PLA Decrease Above (B)- Above (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
PLA Decrease Above (B)-Unknown (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
PLA Decrease Unknown (B)-Below (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
PLA Decrease Unknown (B)-Unknown (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
PLA Increase Below (B)-Above (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
PLA Increase, Below (B)-Unknown (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
PLA Increase Within (B)-Below (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
PLA Increase Within (B)-Within (D8)
|
67 Participants
|
72 Participants
|
63 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
PLA Increase Within (B)-Above (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
PLA Increase Above (B)-Below (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
PLA Increase Above (B)-Within (D8)
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
PLA Increase Unknown (B)-Above (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
WBC Decrease Within (B)-Unknown (D8)
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
WBC Decrease Above (B)-Unknown (D8)
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
WBC Decrease Unknown (B)-Below (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
WBC Increase Below (B)-Within (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
WBC Increase Within (B)- Above (D8)
|
5 Participants
|
8 Participants
|
5 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
WBC Increase Within (B)-Unknown (D8)
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
ERY Decrease Below (B)-Within (D8)
|
4 Participants
|
2 Participants
|
5 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
HEM Increase Within (B)-Below (D8)
|
7 Participants
|
9 Participants
|
7 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
EOS Increase Below (B)-Below (D8)
|
6 Participants
|
5 Participants
|
2 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
EOS Increase Below (B)-Within (D8)
|
6 Participants
|
2 Participants
|
4 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
EOS Increase Below (B)-Above (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
EOS Increase Below (B)-Unknown (D8)
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
EOS Increase Within (B)-Below (D8)
|
2 Participants
|
5 Participants
|
2 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
EOS Increase Within (B)-Within (D8)
|
53 Participants
|
58 Participants
|
56 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
EOS Increase Within (B)-Above (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
EOS Increase Within (B)-Unknown (D8)
|
2 Participants
|
3 Participants
|
1 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
EOS Increase Above (B)-Below (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
EOS Increase Above (B)-Within (D8)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
EOS Increase Above (B)-Above (D8)
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
EOS Increase Above (B)-Unknown (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
EOS Increase Unknown(B)-Below (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
EOS Increase Unknown (B)-Within (D8)
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
EOS Increase Unknown (B)-Above (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
EOS Increase Unknown (B)-Unknown (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
ERY Decrease Below (B)-Below (D8)
|
24 Participants
|
35 Participants
|
23 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
ERY Decrease Below (B)-Above (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
ERY Decrease Below (B)-Unknown (D8)
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
ERY Decrease Within (B)-Below (D8)
|
6 Participants
|
2 Participants
|
7 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
ERY Decrease Within (B)-Within (D8)
|
34 Participants
|
34 Participants
|
29 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
ERY Decrease Within (B)-Above (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
ERY Decrease Within(B)-Unknown (D8)
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
ERY Decrease Above (B)-Below (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
ERY Decrease Above (B)-Within (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
ERY Decrease Above (B)-Above (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
ERY Decrease Above (B)-Unknown (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
ERY Decrease Unknown (B)-Below (D8)
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
ERY Decrease Unknown (B)-Within (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
ERY Decrease Unknown (B)-Above (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
ERY Decrease Unknown (B)-Unknown (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
ERY Increase Below (B)-Below (D8)
|
24 Participants
|
35 Participants
|
23 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
ERY Increase Below (B)-Within (D8)
|
4 Participants
|
2 Participants
|
5 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
ERY Increase Below (B)-Above (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
ERY Increase Below (B)-Unknown (D8)
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
ERY Increase Within (B)-Below (D8)
|
6 Participants
|
2 Participants
|
7 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
ERY Increase Within (B)-Within (D8)
|
34 Participants
|
34 Participants
|
29 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
ERY Increase Within (B)-Above (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
ERY Increase Within (B)-Unknown (D8)
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
ERY Increase Above-Below (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
ERY Increase Above (B)-Within (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
ERY Increase Above (B)-Above (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
ERY Increase Above (B)-Unknown (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
ERY Increase Unknown (B)-Below (D8)
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
ERY Increase Unknown (B)-Within (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
ERY Increase Unknown (B)-Above (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
ERY Increase Unknown (B)-Unknown (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
HEM Decrease Below (B)-Below (D8)
|
25 Participants
|
26 Participants
|
24 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
HEM Decrease Below (B)-Within (D8)
|
2 Participants
|
3 Participants
|
2 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
HEM Decrease Below (B)-Above (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
HEM Decrease Below (B)-Unknown (D8)
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
HEM Decrease Within (B)-Below (D8)
|
7 Participants
|
9 Participants
|
7 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
HEM Decrease Within (B)- Within (D8)
|
34 Participants
|
35 Participants
|
31 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
HEM Decrease Within (B)-Above (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
HEM Decrease Within (B)-Unknown (D8)
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
HEM Decrease Above (B)-Below (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
HEM Decrease Above (B)-Within (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
HEM Decrease Above (B)-Above (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
HEM Decrease Above (B)-Unknown (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
HEM Decrease Unknown (B)-Below (D8)
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
HEM Decrease Unknown (B)-Within (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
HEM Decrease Unknown (B)-Above (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
HEM Decrease Unknown (B)-Unknown (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
HEM Increase Below (B)-Below (D8)
|
25 Participants
|
26 Participants
|
24 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
HEM Increase Below (B)-Within (D8)
|
2 Participants
|
3 Participants
|
2 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
HEM Increase Below (B)-Above (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
HEM Increase Below (B)-Unknown (D8)
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
HEM Increase Within (B)-Within (D8)
|
34 Participants
|
35 Participants
|
31 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
HEM Increase Within (B)-Above (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
HEM Increase Within (B)-Unknown (D8)
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
HEM Increase Above (B)-Below (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
HEM Increase Above (B)-Within (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
HEM Increase Above (B)-Above (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
HEM Increase Above (B)-Unknown (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
HEM Increase Unknown (B)-Below (D8)
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
HEM Increase Unknown (B)-Within (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
HEM Increase Unknown (B)-Above (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
HEM Increase Unknown (B)-Unknown (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
LYMP Decrease Below (B)-Below (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
LYMP Decrease Below (B)-Within (D8)
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
LYMP Decrease Below (B)-Above (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
LYMP Decrease Below (B)-Unknown (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
LYMP Decrease Within (B)-Below (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
LYMP Decrease Within (B)-Within (D8)
|
68 Participants
|
72 Participants
|
63 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
LYMP Decrease Within (B)-Above (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
LYMP Decrease Within (B)-Unknown (D8)
|
2 Participants
|
3 Participants
|
2 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
LYMP Decrease Above (B)-Below (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
LYMP Decrease Above (B)-Within (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
LYMP Decrease Above (B)-Above (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
LYMP Decrease Above (B)-Unknown (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
LYMP Decrease Unknown (B)-Below (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
LYMP Decrease Unknown (B)-Within (D8)
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
LYMP Decrease Unknown (B)-Above (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
LYMP Decrease Unknown (B)-Unknown (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
LYMP Increase Below (B)-Below (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
LYMP Increase Below (B)-Within (D8)
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
LYMP Increase Below (B)-Above (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
LYMP Increase Below (B)-Unknown (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
LYMP Increase Within (B)-Below (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
LYMP Increase Within (B)-Within (D8)
|
68 Participants
|
72 Participants
|
63 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
LYMP Increase Within (B)-Above (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
LYMP Increase Within (B)-Unknown (D8)
|
2 Participants
|
3 Participants
|
2 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
LYMP Increase Above (B)-Below (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
LYMP Increase Above (B)-Within (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
LYMP Increase Above (B)-Above (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
LYMP Increase Above (B)-Unknown (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
LYMP Increase Unknown (B)-Below (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
PLA Decrease Unknown (B)-Within (D8)
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
LYMP Increase Unknown (B)-Within (D8)
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
LYMP Increase Unknown (B)-Above (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
LYMP Increase Unknown (B)-Unknown (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
MCV Decrease Below (B)-Below (D8)
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
MCV Decrease Below (B)-Within (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
MCV Decrease Below (B)-Above (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
MCV Decrease Below (B)-Unknown (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
MCV Decrease Within (B)-Below (D8)
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
MCV Decrease Within (B)-Within (D8)
|
62 Participants
|
66 Participants
|
57 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
MCV Decrease Within (B)-Above (D8)
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
MCV Decrease Within (B)-Unknown (D8)
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
MCV Decrease Above (B)-Below (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
MCV Decrease Above (B)-Within (D8)
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
MCV Decrease Above (B)-Above (D8)
|
2 Participants
|
2 Participants
|
3 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
MCV Decrease Above (B)-Unknown (D8)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
MCV Decrease Unknown (B)-Below (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
MCV Decrease Unknown (B)-Within (D8)
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
MCV Decrease Unknown (B)-Above (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
MCV Decrease Unknown (B)-Unknown (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
PLA Decrease Unknown (B)-Above (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
PLA Increase Below (B)-Below (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
PLA Increase Below (B)-Within (D8)
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
WBC Decrease Above (B)-Within (D8)
|
3 Participants
|
5 Participants
|
3 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
PLA Increase Within (B)-Unknown (D8)
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
PLA Increase Above (B)-Above (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
PLA Increase Above (B)-Unknown (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
PLA Increase Unknown (B)-Below (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
PLA Increase Unknown (B)-Within (D8)
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
PLA Increase Unknown (B)-Unknown (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
WBC Decrease Below (B)-Below (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
WBC Decrease Below (B)-Within (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
WBC Decrease Below (B)-Above (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
WBC Decrease Below (B)-Unknown (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
WBC Decrease Within (B)-Below (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
WBC Decrease Within (B)-Within (D8)
|
46 Participants
|
48 Participants
|
46 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
WBC Decrease Within (B)-Above (D8)
|
5 Participants
|
8 Participants
|
5 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
WBC Decrease Above (B)-Below (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
WBC Decrease Above (B)-Above (D8)
|
14 Participants
|
12 Participants
|
10 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
MCV Increase Below (B)-Below (D8)
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
MCV Increase Below (B)-Within (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
MCV Increase Below (B)-Above (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
MCV Increase Below (B)- Unknown (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
WBC Decrease Unknown (B)-Within (D8)
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
WBC Decrease Unknown (B)-Above (D8)
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
MCV Increase Within (B)-Below (D8)
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
WBC Decrease Unknown (B)-Unknown (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
WBC Increase Below (B)-Below (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
WBC Increase Below (B)-Above (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
WBC Increase Below (B)-Unknown (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
WBC Increase Within (B)-Below (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
WBC Increase Within (B)-Within (D8)
|
46 Participants
|
48 Participants
|
46 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
WBC Increase Above (B)-Below (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
WBC Increase Above (B)-Within (D8)
|
3 Participants
|
5 Participants
|
3 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
WBC Increase Above (B)-Above (D8)
|
14 Participants
|
12 Participants
|
10 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
WBC Increase Above (B)- Unknown (D8)
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
WBC Increase Unknown (B)-Below (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
WBC Increase Unknown (B)-Within (D8)
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
WBC Increase Unknown (B)-Above (D8)
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
WBC Increase Unknown (B)-Unknown (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
MCV Increase Within (B)-Within (D8)
|
62 Participants
|
66 Participants
|
57 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
MCV Increase Within (B)-Above (D8)
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
MCV Increase Within (B)-Unknown (D8)
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
MCV Increase Above (B)-Below (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
MCV Increase Above (B)-Within (D8)
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
MCV Increase Above (B)-Above (D8)
|
2 Participants
|
2 Participants
|
3 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
MCV Increase Above (B)-Unknown (D8)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
MCV Increase Unknown (B)-Below (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
MCV Increase Unknown (B)-Within (D8)
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
MCV Increase Unknown (B)-Above (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
MCV Increase Unknown (B)-Unknown (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
NEU Decrease Below (B)-Below (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
NEU Decrease Below (B)-Within (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
NEU Decrease Below (B)-Above (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
NEU Decrease Below (B)-Unknown (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
NEU Decrease Within (B)-Below (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
NEU Decrease Within (B)-Within (D8)
|
42 Participants
|
46 Participants
|
41 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
NEU Decrease Within (B)-Above (D8)
|
8 Participants
|
9 Participants
|
9 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
NEU Decrease Within (B)-Unknown (D8)
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
NEU Decrease Above (B)-Below (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
NEU Decrease Above (B)-Within (D8)
|
5 Participants
|
5 Participants
|
6 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
NEU Decrease Above (B)-Above (D8)
|
13 Participants
|
12 Participants
|
8 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
NEU Decrease Above (B)-Unknown (D8)
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
NEU Decrease Unknown (B)-Below (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
NEU Decrease Unknown (B)-Within (D8)
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
NEU Decrease Unknown (B)-Above (D8)
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
NEU Decrease Unknown (B)-Unknown (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
PLA Decrease Below (B)-Below (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
PLA Decrease Below (B)-Within (D8)
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
PLA Decrease Below (B)-Above (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
PLA Decrease Below (B)-Unknown (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
PLA Decrease Within (B)-Below (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
PLA Decrease Within (B)-Within (D8)
|
67 Participants
|
72 Participants
|
63 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
PLA Decrease Within (B)-Above (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
PLA Decrease Within (B)-Unknown (D8)
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
PLA Decrease Above (B)-Below (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
PLA Decrease Above (B)-Within (D8)
|
0 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: At Day 8Population: The analysis was performed on the ESM, which included all the maternal subjects who received at least 1 dose of study intervention.
Biochemical parameters assessed were Alanine Amino-Transferase (ALT), Aspartate Amino-Transferase (AST), Creatinine (CRE) and Urea nitrogen (URN). The increase was evaluated only for AST and ALT parameters at Day 8. Abnormal laboratory values refer to range indicator at Day 8 (D8) categorized as Missing, Below, Within and Above normal values and compared to the baseline (B) range indicator of the same parameter, at Screening (up to 15 days before vaccination) i.e. Missing, Below, Within and Above. E.g. 'AST increase Below (B) - Within (D8)' = AST increase in subjects with below normal values at baseline and within normal values at Day 8.
Outcome measures
| Measure |
RSV MAT 60 Group-Mother
n=70 Participants
Maternal subjects randomized to RSV MAT 60 Group received a single dose of RSV MAT (60 µg) vaccine at Day 1, and were followed up until the study end.
|
RSV MAT 120 Group-Mother
n=75 Participants
Maternal subjects randomized to RSV MAT 120 group received a single dose of RSV MAT (120 µg) vaccine at Day 1, and were followed up until the study end.
|
Control Group-Mother
n=68 Participants
Maternal subjects randomized to the Control Group received a single dose of Placebo at Day 1, and were followed up until the study end.
|
|---|---|---|---|
|
Number of Maternal Subjects With Any Biochemical Laboratory Abnormalities at Day 8 by Baseline Ranges
URN Below (B)-Above (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Biochemical Laboratory Abnormalities at Day 8 by Baseline Ranges
URN Below (B)-Unknown (D8)
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Maternal Subjects With Any Biochemical Laboratory Abnormalities at Day 8 by Baseline Ranges
URN Within (B)-Below (D8)
|
5 Participants
|
4 Participants
|
9 Participants
|
|
Number of Maternal Subjects With Any Biochemical Laboratory Abnormalities at Day 8 by Baseline Ranges
URN Within (B)-Within (D8)
|
45 Participants
|
49 Participants
|
39 Participants
|
|
Number of Maternal Subjects With Any Biochemical Laboratory Abnormalities at Day 8 by Baseline Ranges
URN Within (B)-Above (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Biochemical Laboratory Abnormalities at Day 8 by Baseline Ranges
URN Within (B)-Unknown (D8)
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Biochemical Laboratory Abnormalities at Day 8 by Baseline Ranges
URN Above (B)-Below (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Biochemical Laboratory Abnormalities at Day 8 by Baseline Ranges
URN Above (B)-Within (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Biochemical Laboratory Abnormalities at Day 8 by Baseline Ranges
URN Above (B)-Above (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Biochemical Laboratory Abnormalities at Day 8 by Baseline Ranges
URN Above (B)-Unknown (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Biochemical Laboratory Abnormalities at Day 8 by Baseline Ranges
URN Unknown (B)-Below (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Biochemical Laboratory Abnormalities at Day 8 by Baseline Ranges
URN Unknown (B)-Within (D8)
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Number of Maternal Subjects With Any Biochemical Laboratory Abnormalities at Day 8 by Baseline Ranges
URN Unknown (B)-Above (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Biochemical Laboratory Abnormalities at Day 8 by Baseline Ranges
URN Unknown (B)-Unknown (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Biochemical Laboratory Abnormalities at Day 8 by Baseline Ranges
ALT increase Above (B)- Within (D8)
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Biochemical Laboratory Abnormalities at Day 8 by Baseline Ranges
ALT increase Above (B)- Above (D8)
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Biochemical Laboratory Abnormalities at Day 8 by Baseline Ranges
ALT increase Unknown (B)-Below (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Biochemical Laboratory Abnormalities at Day 8 by Baseline Ranges
ALT increase Unknown (B)-Above (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Biochemical Laboratory Abnormalities at Day 8 by Baseline Ranges
AST increase Below (B)- Within (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Biochemical Laboratory Abnormalities at Day 8 by Baseline Ranges
AST increase Below (B)- Above (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Biochemical Laboratory Abnormalities at Day 8 by Baseline Ranges
AST increase Within (B)- Below (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Biochemical Laboratory Abnormalities at Day 8 by Baseline Ranges
AST increase Within (B)-Within (D8)
|
67 Participants
|
71 Participants
|
65 Participants
|
|
Number of Maternal Subjects With Any Biochemical Laboratory Abnormalities at Day 8 by Baseline Ranges
AST increase Above (B)-Above (D8)
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Biochemical Laboratory Abnormalities at Day 8 by Baseline Ranges
AST increase Above (B)-Unknown (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Biochemical Laboratory Abnormalities at Day 8 by Baseline Ranges
AST increase Unknown (B)-Below (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Biochemical Laboratory Abnormalities at Day 8 by Baseline Ranges
AST increase Unknown (B)-Above (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Biochemical Laboratory Abnormalities at Day 8 by Baseline Ranges
AST increase Unknown (B)-Unknown (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Biochemical Laboratory Abnormalities at Day 8 by Baseline Ranges
Creatinine Below (B)-Below (D8)
|
16 Participants
|
18 Participants
|
18 Participants
|
|
Number of Maternal Subjects With Any Biochemical Laboratory Abnormalities at Day 8 by Baseline Ranges
Creatinine Below (B)-Within (D8)
|
6 Participants
|
9 Participants
|
4 Participants
|
|
Number of Maternal Subjects With Any Biochemical Laboratory Abnormalities at Day 8 by Baseline Ranges
Creatinine Below (B)-Above (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Biochemical Laboratory Abnormalities at Day 8 by Baseline Ranges
Creatinine Below (B)- Unknown (D8)
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Maternal Subjects With Any Biochemical Laboratory Abnormalities at Day 8 by Baseline Ranges
Creatinine Within (B)-Unknown (D8)
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Biochemical Laboratory Abnormalities at Day 8 by Baseline Ranges
ALT increase Unknown (B)-Within (D8)
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Maternal Subjects With Any Biochemical Laboratory Abnormalities at Day 8 by Baseline Ranges
ALT increase Below (B)-Below (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Biochemical Laboratory Abnormalities at Day 8 by Baseline Ranges
ALT increase Below (B)- Within (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Biochemical Laboratory Abnormalities at Day 8 by Baseline Ranges
ALT increase Below (B)- Above (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Biochemical Laboratory Abnormalities at Day 8 by Baseline Ranges
ALT increase Below (B)-Unknown (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Biochemical Laboratory Abnormalities at Day 8 by Baseline Ranges
ALT increase Within (B)- Below (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Biochemical Laboratory Abnormalities at Day 8 by Baseline Ranges
ALT increase Within (B)-Within (D8)
|
64 Participants
|
69 Participants
|
65 Participants
|
|
Number of Maternal Subjects With Any Biochemical Laboratory Abnormalities at Day 8 by Baseline Ranges
ALT increase Within (B)- Above (D8)
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Biochemical Laboratory Abnormalities at Day 8 by Baseline Ranges
ALT increase Within (B)-Unknown (D8)
|
2 Participants
|
3 Participants
|
1 Participants
|
|
Number of Maternal Subjects With Any Biochemical Laboratory Abnormalities at Day 8 by Baseline Ranges
ALT increase Above (B)- Below (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Biochemical Laboratory Abnormalities at Day 8 by Baseline Ranges
ALT increase Above (B)-Unknown (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Biochemical Laboratory Abnormalities at Day 8 by Baseline Ranges
ALT increase Unknown (B)-Unknown (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Biochemical Laboratory Abnormalities at Day 8 by Baseline Ranges
AST increase Below (B)-Below (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Biochemical Laboratory Abnormalities at Day 8 by Baseline Ranges
AST increase Below (B)-Unknown (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Biochemical Laboratory Abnormalities at Day 8 by Baseline Ranges
AST increase Within (B)- Above (D8)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Biochemical Laboratory Abnormalities at Day 8 by Baseline Ranges
AST increase Within (B)-Unknown (D8)
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Maternal Subjects With Any Biochemical Laboratory Abnormalities at Day 8 by Baseline Ranges
AST increase Above (B)- Below (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Biochemical Laboratory Abnormalities at Day 8 by Baseline Ranges
AST increase Above (B)-Within (D8)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Biochemical Laboratory Abnormalities at Day 8 by Baseline Ranges
AST increase Unknown (B)-Within (D8)
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Maternal Subjects With Any Biochemical Laboratory Abnormalities at Day 8 by Baseline Ranges
Creatinine Above (B)-Within (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Biochemical Laboratory Abnormalities at Day 8 by Baseline Ranges
Creatinine Above (B)-Above (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Biochemical Laboratory Abnormalities at Day 8 by Baseline Ranges
Creatinine Above (B)-Unknown (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Biochemical Laboratory Abnormalities at Day 8 by Baseline Ranges
Creatinine Unknown (B)-Below (D8)
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Maternal Subjects With Any Biochemical Laboratory Abnormalities at Day 8 by Baseline Ranges
Creatinine Unknown (B)-Within (D8)
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Maternal Subjects With Any Biochemical Laboratory Abnormalities at Day 8 by Baseline Ranges
Creatinine Unknown (B)-Above (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Biochemical Laboratory Abnormalities at Day 8 by Baseline Ranges
Creatinine Unknown (B)-Unknown (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Biochemical Laboratory Abnormalities at Day 8 by Baseline Ranges
URN Below (B)-Below (D8)
|
13 Participants
|
15 Participants
|
13 Participants
|
|
Number of Maternal Subjects With Any Biochemical Laboratory Abnormalities at Day 8 by Baseline Ranges
URN Below (B)-Within (D8)
|
6 Participants
|
4 Participants
|
3 Participants
|
|
Number of Maternal Subjects With Any Biochemical Laboratory Abnormalities at Day 8 by Baseline Ranges
Creatinine Within (B)-Below (D8)
|
2 Participants
|
4 Participants
|
6 Participants
|
|
Number of Maternal Subjects With Any Biochemical Laboratory Abnormalities at Day 8 by Baseline Ranges
Creatinine Within (B)-Within (D8)
|
45 Participants
|
42 Participants
|
37 Participants
|
|
Number of Maternal Subjects With Any Biochemical Laboratory Abnormalities at Day 8 by Baseline Ranges
Creatinine Within (B)-Above (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Subjects With Any Biochemical Laboratory Abnormalities at Day 8 by Baseline Ranges
Creatinine Above (B)-Below (D8)
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: During 30-day follow-up period after vaccination (i.e. the day of vaccination and 29 subsequent days)Population: The analysis was performed on the Unsolicited Safety Set-Maternal, which included maternal subjects who received at least 1 dose of the study intervention (ESM) that reported unsolicited AEs/reported not having unsolicited AEs.
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Unsolicited AE is any AE reported in addition to those solicited during the clinical study and that was spontaneously communicated by a maternal subject. Also, any solicited symptom with onset outside the specified period of follow-up for solicited symptoms is to be reported as an unsolicited AE. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Outcome measures
| Measure |
RSV MAT 60 Group-Mother
n=70 Participants
Maternal subjects randomized to RSV MAT 60 Group received a single dose of RSV MAT (60 µg) vaccine at Day 1, and were followed up until the study end.
|
RSV MAT 120 Group-Mother
n=75 Participants
Maternal subjects randomized to RSV MAT 120 group received a single dose of RSV MAT (120 µg) vaccine at Day 1, and were followed up until the study end.
|
Control Group-Mother
n=68 Participants
Maternal subjects randomized to the Control Group received a single dose of Placebo at Day 1, and were followed up until the study end.
|
|---|---|---|---|
|
Percentage of Maternal Subjects With Any Unsolicited Adverse Events (AEs)
|
30 Percentage of maternal subjects
Interval 19.6 to 42.1
|
33.3 Percentage of maternal subjects
Interval 22.9 to 45.2
|
33.8 Percentage of maternal subjects
Interval 22.8 to 46.3
|
PRIMARY outcome
Timeframe: From Day 1 to Day 43 post-deliveryPopulation: The analysis was performed on the ESM, which included all the maternal subjects who received at least 1 dose of study intervention.
SAEs assessed included any untoward medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity, was a congenital anomaly/birth defect in the offspring of a study subject or abnormal pregnancy outcomes (spontaneous abortion, foetal death, stillbirth, congenital anomalies, ectopic pregnancy), other situations (medical events that might jeopardize the participant or required medical/surgical intervention to prevent one of the other SAEs listed above: e.g. invasive/malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalization). Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination.
Outcome measures
| Measure |
RSV MAT 60 Group-Mother
n=70 Participants
Maternal subjects randomized to RSV MAT 60 Group received a single dose of RSV MAT (60 µg) vaccine at Day 1, and were followed up until the study end.
|
RSV MAT 120 Group-Mother
n=75 Participants
Maternal subjects randomized to RSV MAT 120 group received a single dose of RSV MAT (120 µg) vaccine at Day 1, and were followed up until the study end.
|
Control Group-Mother
n=68 Participants
Maternal subjects randomized to the Control Group received a single dose of Placebo at Day 1, and were followed up until the study end.
|
|---|---|---|---|
|
Percentage of Maternal Subjects With Any Serious Adverse Events (SAEs)
|
22.9 Percentage of maternal subjects
Interval 13.7 to 34.4
|
26.7 Percentage of maternal subjects
Interval 17.1 to 38.1
|
22.1 Percentage of maternal subjects
Interval 12.9 to 33.8
|
PRIMARY outcome
Timeframe: From Day 1 to Day 43 post-deliveryPopulation: The analysis was performed on the ESM, which included all the maternal subjects who received at least 1 dose of study intervention.
An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs leading to study withdrawal = AEs identified by investigators to cause subject(s) withdrawal until the resolution of the event. These subject withdrawals were considered different from subject withdrawals for other reasons.
Outcome measures
| Measure |
RSV MAT 60 Group-Mother
n=70 Participants
Maternal subjects randomized to RSV MAT 60 Group received a single dose of RSV MAT (60 µg) vaccine at Day 1, and were followed up until the study end.
|
RSV MAT 120 Group-Mother
n=75 Participants
Maternal subjects randomized to RSV MAT 120 group received a single dose of RSV MAT (120 µg) vaccine at Day 1, and were followed up until the study end.
|
Control Group-Mother
n=68 Participants
Maternal subjects randomized to the Control Group received a single dose of Placebo at Day 1, and were followed up until the study end.
|
|---|---|---|---|
|
Percentage of Maternal Subjects With AEs Leading to Study Withdrawal
|
0 Percentage of maternal subjects
Interval 0.0 to 0.0
|
0 Percentage of maternal subjects
Interval 0.0 to 0.0
|
0 Percentage of maternal subjects
Interval 0.0 to 0.0
|
PRIMARY outcome
Timeframe: From Day 1 to Day 43 post-deliveryPopulation: The analysis was performed on the ESM, which included all the maternal subjects who received at least 1 dose of study intervention.
MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Also, for instances where, due to the special circumstances, the subject could not seek medical advice for symptoms/an illness by visiting a medical facility or arranging for a home visit, the subject sought this advice instead via telephone, SMS, email, videotelephony or telemedicine, or other means. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination.
Outcome measures
| Measure |
RSV MAT 60 Group-Mother
n=70 Participants
Maternal subjects randomized to RSV MAT 60 Group received a single dose of RSV MAT (60 µg) vaccine at Day 1, and were followed up until the study end.
|
RSV MAT 120 Group-Mother
n=75 Participants
Maternal subjects randomized to RSV MAT 120 group received a single dose of RSV MAT (120 µg) vaccine at Day 1, and were followed up until the study end.
|
Control Group-Mother
n=68 Participants
Maternal subjects randomized to the Control Group received a single dose of Placebo at Day 1, and were followed up until the study end.
|
|---|---|---|---|
|
Percentage of Maternal Subjects With Any Medically Attended AEs (MAE)
|
41.4 Percentage of maternal subjects
Interval 29.8 to 53.8
|
48 Percentage of maternal subjects
Interval 36.3 to 59.8
|
42.6 Percentage of maternal subjects
Interval 30.7 to 55.2
|
PRIMARY outcome
Timeframe: From Day 1 to Day 43 post-deliveryPopulation: The analysis was performed on the ESM, which included all the maternal subjects who received at least 1 dose of study intervention.
Pregnancy outcomes were: live birth with no congenital anomalies, live birth with congenital anomalies, Fetal death/still birth with no Congenital Anomalies (CA) - Antepartum and Unknown (Subjects withdrew from the study before delivery and pregnancy outcome information was not available for them).
Outcome measures
| Measure |
RSV MAT 60 Group-Mother
n=70 Participants
Maternal subjects randomized to RSV MAT 60 Group received a single dose of RSV MAT (60 µg) vaccine at Day 1, and were followed up until the study end.
|
RSV MAT 120 Group-Mother
n=75 Participants
Maternal subjects randomized to RSV MAT 120 group received a single dose of RSV MAT (120 µg) vaccine at Day 1, and were followed up until the study end.
|
Control Group-Mother
n=68 Participants
Maternal subjects randomized to the Control Group received a single dose of Placebo at Day 1, and were followed up until the study end.
|
|---|---|---|---|
|
Percentage of Maternal Subjects With Pregnancy Outcomes
Live birth with no congenital anomalies
|
84.3 Percentage of maternal subjects
Interval 73.6 to 91.9
|
81.3 Percentage of maternal subjects
Interval 70.7 to 89.4
|
80.9 Percentage of maternal subjects
Interval 69.5 to 89.4
|
|
Percentage of Maternal Subjects With Pregnancy Outcomes
Live birth with congenital anomalies
|
12.9 Percentage of maternal subjects
Interval 6.1 to 23.0
|
16 Percentage of maternal subjects
Interval 8.6 to 26.3
|
16.2 Percentage of maternal subjects
Interval 8.4 to 27.1
|
|
Percentage of Maternal Subjects With Pregnancy Outcomes
Fetal death/still birth with no CA- Antepartum
|
0 Percentage of maternal subjects
Interval 0.0 to 5.1
|
0 Percentage of maternal subjects
Interval 0.0 to 4.8
|
1.5 Percentage of maternal subjects
Interval 0.0 to 7.9
|
|
Percentage of Maternal Subjects With Pregnancy Outcomes
Unknown
|
2.9 Percentage of maternal subjects
Interval 0.3 to 9.9
|
2.7 Percentage of maternal subjects
Interval 0.3 to 9.3
|
1.5 Percentage of maternal subjects
Interval 0.0 to 7.9
|
PRIMARY outcome
Timeframe: From Day 1 to Day 43 post-deliveryPopulation: The analysis was performed on the ESM, which included all the maternal subjects who received at least 1 dose of study intervention.
Pregnancy-related AESIs were: Non-Reassuring Fetal Status, Hypertensive Disorders of Pregnancy (HDP), Oligohydramnios, Pathways to Preterm Birth (PPB), Chorioamnionitis, Fetal Growth Restriction, Gestational Liver Disease (GLD), Postpartum Haemorrhage and Gestational Diabetes Mellitus.
Outcome measures
| Measure |
RSV MAT 60 Group-Mother
n=70 Participants
Maternal subjects randomized to RSV MAT 60 Group received a single dose of RSV MAT (60 µg) vaccine at Day 1, and were followed up until the study end.
|
RSV MAT 120 Group-Mother
n=75 Participants
Maternal subjects randomized to RSV MAT 120 group received a single dose of RSV MAT (120 µg) vaccine at Day 1, and were followed up until the study end.
|
Control Group-Mother
n=68 Participants
Maternal subjects randomized to the Control Group received a single dose of Placebo at Day 1, and were followed up until the study end.
|
|---|---|---|---|
|
Percentage of Maternal Subjects With Pregnancy-related Adverse Events of Special Interest (AESIs)
HDP-Gestational Hypertension
|
4.3 Percentage of maternal subjects
Interval 0.9 to 12.0
|
2.7 Percentage of maternal subjects
Interval 0.3 to 9.3
|
1.5 Percentage of maternal subjects
Interval 0.0 to 7.9
|
|
Percentage of Maternal Subjects With Pregnancy-related Adverse Events of Special Interest (AESIs)
PPB-Preterm Labor
|
0 Percentage of maternal subjects
Interval 0.0 to 5.1
|
2.7 Percentage of maternal subjects
Interval 0.3 to 9.3
|
2.9 Percentage of maternal subjects
Interval 0.4 to 10.2
|
|
Percentage of Maternal Subjects With Pregnancy-related Adverse Events of Special Interest (AESIs)
PPB-Preterm Rupture Of Membranes
|
1.4 Percentage of maternal subjects
Interval 0.0 to 7.7
|
0 Percentage of maternal subjects
Interval 0.0 to 4.8
|
1.5 Percentage of maternal subjects
Interval 0.0 to 7.9
|
|
Percentage of Maternal Subjects With Pregnancy-related Adverse Events of Special Interest (AESIs)
PPB-Provider-Initiated Preterm Birth
|
0 Percentage of maternal subjects
Interval 0.0 to 5.1
|
1.3 Percentage of maternal subjects
Interval 0.0 to 7.2
|
0 Percentage of maternal subjects
Interval 0.0 to 5.3
|
|
Percentage of Maternal Subjects With Pregnancy-related Adverse Events of Special Interest (AESIs)
Chorioamnionitis
|
2.9 Percentage of maternal subjects
Interval 0.3 to 9.9
|
2.7 Percentage of maternal subjects
Interval 0.3 to 9.3
|
1.5 Percentage of maternal subjects
Interval 0.0 to 7.9
|
|
Percentage of Maternal Subjects With Pregnancy-related Adverse Events of Special Interest (AESIs)
Fetal Growth Restriction
|
1.4 Percentage of maternal subjects
Interval 0.0 to 7.7
|
2.7 Percentage of maternal subjects
Interval 0.3 to 9.3
|
0 Percentage of maternal subjects
Interval 0.0 to 5.3
|
|
Percentage of Maternal Subjects With Pregnancy-related Adverse Events of Special Interest (AESIs)
GLD-Intrahepatic Cholestasis Of Pregnancy
|
2.9 Percentage of maternal subjects
Interval 0.3 to 9.9
|
1.3 Percentage of maternal subjects
Interval 0.0 to 7.2
|
0 Percentage of maternal subjects
Interval 0.0 to 5.3
|
|
Percentage of Maternal Subjects With Pregnancy-related Adverse Events of Special Interest (AESIs)
Postpartum Haemorrhage
|
1.4 Percentage of maternal subjects
Interval 0.0 to 7.7
|
0 Percentage of maternal subjects
Interval 0.0 to 4.8
|
1.5 Percentage of maternal subjects
Interval 0.0 to 7.9
|
|
Percentage of Maternal Subjects With Pregnancy-related Adverse Events of Special Interest (AESIs)
Gestational Diabetes Mellitus
|
1.4 Percentage of maternal subjects
Interval 0.0 to 7.7
|
0 Percentage of maternal subjects
Interval 0.0 to 4.8
|
0 Percentage of maternal subjects
Interval 0.0 to 5.3
|
|
Percentage of Maternal Subjects With Pregnancy-related Adverse Events of Special Interest (AESIs)
Non-Reassuring Fetal Status
|
8.6 Percentage of maternal subjects
Interval 3.2 to 17.7
|
12 Percentage of maternal subjects
Interval 5.6 to 21.6
|
11.8 Percentage of maternal subjects
Interval 5.2 to 21.9
|
|
Percentage of Maternal Subjects With Pregnancy-related Adverse Events of Special Interest (AESIs)
HDP-Pre-Eclampsia
|
5.7 Percentage of maternal subjects
Interval 1.6 to 14.0
|
2.7 Percentage of maternal subjects
Interval 0.3 to 9.3
|
0 Percentage of maternal subjects
Interval 0.0 to 5.3
|
|
Percentage of Maternal Subjects With Pregnancy-related Adverse Events of Special Interest (AESIs)
Oligohydramnios
|
4.3 Percentage of maternal subjects
Interval 0.9 to 12.0
|
2.7 Percentage of maternal subjects
Interval 0.3 to 9.3
|
1.5 Percentage of maternal subjects
Interval 0.0 to 7.9
|
PRIMARY outcome
Timeframe: From birth to Day 43 post-birthPopulation: The analysis was performed on the Exposed Set-Infant (ESI), which included all the infants live-born to exposed maternal subjects, whose parents/LARs completed the informed consent process and signed the informed consent form.
Neonatal AESIs, reported up to 6 weeks after birth were: Respiratory Distress In The Neonate, Macrosomia, Low Birth Weight, Small For Gestational Age, Preterm Birth, Large For Gestational Age, Neonatal Invasive Blood Stream Infections (NIBSI) and Congenital Anomalies (CA).
Outcome measures
| Measure |
RSV MAT 60 Group-Mother
n=67 Participants
Maternal subjects randomized to RSV MAT 60 Group received a single dose of RSV MAT (60 µg) vaccine at Day 1, and were followed up until the study end.
|
RSV MAT 120 Group-Mother
n=73 Participants
Maternal subjects randomized to RSV MAT 120 group received a single dose of RSV MAT (120 µg) vaccine at Day 1, and were followed up until the study end.
|
Control Group-Mother
n=66 Participants
Maternal subjects randomized to the Control Group received a single dose of Placebo at Day 1, and were followed up until the study end.
|
|---|---|---|---|
|
Percentage of Infant Subjects With Neonatal AESIs
Small For Gestational Age
|
3 Percentage of infant subjects
Interval 0.4 to 10.4
|
4.1 Percentage of infant subjects
Interval 0.9 to 11.5
|
3 Percentage of infant subjects
Interval 0.4 to 10.5
|
|
Percentage of Infant Subjects With Neonatal AESIs
Large For Gestational Age
|
3 Percentage of infant subjects
Interval 0.4 to 10.4
|
0 Percentage of infant subjects
Interval 0.0 to 4.9
|
4.5 Percentage of infant subjects
Interval 0.9 to 12.7
|
|
Percentage of Infant Subjects With Neonatal AESIs
NIBSI: Bacterial/Fungal/Viral
|
0 Percentage of infant subjects
Interval 0.0 to 5.4
|
1.4 Percentage of infant subjects
Interval 0.0 to 7.4
|
1.5 Percentage of infant subjects
Interval 0.0 to 8.2
|
|
Percentage of Infant Subjects With Neonatal AESIs
Respiratory Distress In The Neonate
|
6 Percentage of infant subjects
Interval 1.7 to 14.6
|
6.8 Percentage of infant subjects
Interval 2.3 to 15.3
|
6.1 Percentage of infant subjects
Interval 1.7 to 14.8
|
|
Percentage of Infant Subjects With Neonatal AESIs
Macrosomia
|
3 Percentage of infant subjects
Interval 0.4 to 10.4
|
2.7 Percentage of infant subjects
Interval 0.3 to 9.5
|
7.6 Percentage of infant subjects
Interval 2.5 to 16.8
|
|
Percentage of Infant Subjects With Neonatal AESIs
Low Birth Weight
|
1.5 Percentage of infant subjects
Interval 0.0 to 8.0
|
5.5 Percentage of infant subjects
Interval 1.5 to 13.4
|
3 Percentage of infant subjects
Interval 0.4 to 10.5
|
|
Percentage of Infant Subjects With Neonatal AESIs
Preterm Birth
|
1.5 Percentage of infant subjects
Interval 0.0 to 8.0
|
4.1 Percentage of infant subjects
Interval 0.9 to 11.5
|
3 Percentage of infant subjects
Interval 0.4 to 10.5
|
|
Percentage of Infant Subjects With Neonatal AESIs
NIBSI: Bacterial/Fungal/Viral Meningitis
|
0 Percentage of infant subjects
Interval 0.0 to 5.4
|
1.4 Percentage of infant subjects
Interval 0.0 to 7.4
|
0 Percentage of infant subjects
Interval 0.0 to 5.4
|
|
Percentage of Infant Subjects With Neonatal AESIs
NIBSI: Respiratory Bacterial/Fungal/Viral Infection
|
0 Percentage of infant subjects
Interval 0.0 to 5.4
|
0 Percentage of infant subjects
Interval 0.0 to 4.9
|
1.5 Percentage of infant subjects
Interval 0.0 to 8.2
|
|
Percentage of Infant Subjects With Neonatal AESIs
CA- Major External Structural Defects
|
0 Percentage of infant subjects
Interval 0.0 to 5.4
|
2.7 Percentage of infant subjects
Interval 0.3 to 9.5
|
0 Percentage of infant subjects
Interval 0.0 to 5.4
|
|
Percentage of Infant Subjects With Neonatal AESIs
CA- Functional Defects
|
0 Percentage of infant subjects
Interval 0.0 to 5.4
|
1.4 Percentage of infant subjects
Interval 0.0 to 7.4
|
0 Percentage of infant subjects
Interval 0.0 to 5.4
|
|
Percentage of Infant Subjects With Neonatal AESIs
CA- Internal Structural Defects
|
0 Percentage of infant subjects
Interval 0.0 to 5.4
|
1.4 Percentage of infant subjects
Interval 0.0 to 7.4
|
0 Percentage of infant subjects
Interval 0.0 to 5.4
|
PRIMARY outcome
Timeframe: From birth to Day 43 post-birthPopulation: The analysis was performed on the ESI, which included all the infants live-born to exposed maternal subjects, whose parents/LARs completed the informed consent process and signed the informed consent form.
SAEs assessed included any untoward medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity or is a congenital anomaly/birth defect, other situations (medical events that might jeopardize the participant or required medical/surgical intervention to prevent one of the other SAEs listed above: e.g. invasive/malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalization). Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination.
Outcome measures
| Measure |
RSV MAT 60 Group-Mother
n=67 Participants
Maternal subjects randomized to RSV MAT 60 Group received a single dose of RSV MAT (60 µg) vaccine at Day 1, and were followed up until the study end.
|
RSV MAT 120 Group-Mother
n=73 Participants
Maternal subjects randomized to RSV MAT 120 group received a single dose of RSV MAT (120 µg) vaccine at Day 1, and were followed up until the study end.
|
Control Group-Mother
n=66 Participants
Maternal subjects randomized to the Control Group received a single dose of Placebo at Day 1, and were followed up until the study end.
|
|---|---|---|---|
|
Percentage of Infant Subjects With Any SAEs
|
22.4 Percentage of infant subjects
Interval 13.1 to 34.2
|
27.4 Percentage of infant subjects
Interval 17.6 to 39.1
|
28.8 Percentage of infant subjects
Interval 18.3 to 41.3
|
PRIMARY outcome
Timeframe: From birth to Day 43 post-birthPopulation: The analysis was performed on the ESI, which included all the infants live-born to exposed maternal subjects, whose parents/LARs completed the informed consent process and signed the informed consent form.
An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs leading to study withdrawal = AEs identified by investigators to cause subject(s) withdrawal until the resolution of the event. These subject withdrawals were considered different from subject withdrawals for other reasons.
Outcome measures
| Measure |
RSV MAT 60 Group-Mother
n=67 Participants
Maternal subjects randomized to RSV MAT 60 Group received a single dose of RSV MAT (60 µg) vaccine at Day 1, and were followed up until the study end.
|
RSV MAT 120 Group-Mother
n=73 Participants
Maternal subjects randomized to RSV MAT 120 group received a single dose of RSV MAT (120 µg) vaccine at Day 1, and were followed up until the study end.
|
Control Group-Mother
n=66 Participants
Maternal subjects randomized to the Control Group received a single dose of Placebo at Day 1, and were followed up until the study end.
|
|---|---|---|---|
|
Percentage of Infant Subjects With AEs Leading to Study Withdrawal
|
0 Percentage of infant subjects
Interval 0.0 to 0.0
|
0 Percentage of infant subjects
Interval 0.0 to 0.0
|
0 Percentage of infant subjects
Interval 0.0 to 0.0
|
PRIMARY outcome
Timeframe: From birth to Day 43 post-birthPopulation: The analysis was performed on the ESI, which included all the infants live-born to exposed maternal subjects, whose parents/LARs completed the informed consent process and signed the informed consent form.
MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Also, for instances where, due to the special circumstances, the subject could not seek medical advice for symptoms/an illness by visiting a medical facility or arranging for a home visit, the subject sought this advice instead via telephone, SMS, email, videotelephony or telemedicine, or other means. Any = occurrence of the symptom regardless of intensity grade.
Outcome measures
| Measure |
RSV MAT 60 Group-Mother
n=67 Participants
Maternal subjects randomized to RSV MAT 60 Group received a single dose of RSV MAT (60 µg) vaccine at Day 1, and were followed up until the study end.
|
RSV MAT 120 Group-Mother
n=73 Participants
Maternal subjects randomized to RSV MAT 120 group received a single dose of RSV MAT (120 µg) vaccine at Day 1, and were followed up until the study end.
|
Control Group-Mother
n=66 Participants
Maternal subjects randomized to the Control Group received a single dose of Placebo at Day 1, and were followed up until the study end.
|
|---|---|---|---|
|
Percentage of Infant Subjects With Any MAEs
|
25.4 Percentage of infant subjects
Interval 15.5 to 37.5
|
35.6 Percentage of infant subjects
Interval 24.7 to 47.7
|
30.3 Percentage of infant subjects
Interval 19.6 to 42.9
|
PRIMARY outcome
Timeframe: At Day 1 (before vaccination), Day 31 and at deliveryPopulation: The analysis was performed on the Per Protocol Set-Maternal (PPSM) for immunogenicity which included all the maternal subjects who received at least 1 dose of the study intervention to which they were randomized and had post-vaccination data minus those subjects with protocol deviations that lead to exclusion.
Serological assays for the determination of IgG antibodies against RSV MAT were performed by Enzyme-linked immunosorbent assay (ELISA). The corresponding antibody concentrations were expressed in ELISA units per milliliter (EU/mL) and were measured on blood samples collected from vaccinated maternal subjects.
Outcome measures
| Measure |
RSV MAT 60 Group-Mother
n=68 Participants
Maternal subjects randomized to RSV MAT 60 Group received a single dose of RSV MAT (60 µg) vaccine at Day 1, and were followed up until the study end.
|
RSV MAT 120 Group-Mother
n=72 Participants
Maternal subjects randomized to RSV MAT 120 group received a single dose of RSV MAT (120 µg) vaccine at Day 1, and were followed up until the study end.
|
Control Group-Mother
n=68 Participants
Maternal subjects randomized to the Control Group received a single dose of Placebo at Day 1, and were followed up until the study end.
|
|---|---|---|---|
|
RSV MAT Immunoglobulin G (IgG)-Specific Antibody Concentrations in Terms of Geometric Mean Concentrations (GMCs) in Maternal Subjects
Day 1
|
5681 EU/mL
Interval 4851.0 to 6653.0
|
5837 EU/mL
Interval 4962.0 to 6865.0
|
6147 EU/mL
Interval 5224.0 to 7234.0
|
|
RSV MAT Immunoglobulin G (IgG)-Specific Antibody Concentrations in Terms of Geometric Mean Concentrations (GMCs) in Maternal Subjects
Day 31
|
80986 EU/mL
Interval 66746.0 to 98263.0
|
105138 EU/mL
Interval 93657.0 to 118025.0
|
6597 EU/mL
Interval 5252.0 to 8288.0
|
|
RSV MAT Immunoglobulin G (IgG)-Specific Antibody Concentrations in Terms of Geometric Mean Concentrations (GMCs) in Maternal Subjects
Delivery
|
59395 EU/mL
Interval 50742.0 to 69524.0
|
59715 EU/mL
Interval 51417.0 to 69352.0
|
5555 EU/mL
Interval 4568.0 to 6755.0
|
PRIMARY outcome
Timeframe: At Day 1 (before vaccination), Day 31 and at deliveryPopulation: The analysis was performed on the PPSM for immunogenicity which included all the maternal subjects who received at least 1 dose of the study intervention to which they were randomized and had post-vaccination data minus those subjects with protocol deviations that lead to exclusion.
Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay. The corresponding antibody titers were expressed in Estimated Dilution 60 (ED60) and were measured on blood samples collected from vaccinated maternal subjects.
Outcome measures
| Measure |
RSV MAT 60 Group-Mother
n=68 Participants
Maternal subjects randomized to RSV MAT 60 Group received a single dose of RSV MAT (60 µg) vaccine at Day 1, and were followed up until the study end.
|
RSV MAT 120 Group-Mother
n=73 Participants
Maternal subjects randomized to RSV MAT 120 group received a single dose of RSV MAT (120 µg) vaccine at Day 1, and were followed up until the study end.
|
Control Group-Mother
n=68 Participants
Maternal subjects randomized to the Control Group received a single dose of Placebo at Day 1, and were followed up until the study end.
|
|---|---|---|---|
|
RSV-A Neutralizing Antibody Geometric Mean Titers (GMTs) in Maternal Subjects
Day 1
|
671.8 Titers
Interval 544.1 to 829.4
|
694.7 Titers
Interval 565.8 to 852.9
|
735.6 Titers
Interval 586.7 to 922.1
|
|
RSV-A Neutralizing Antibody Geometric Mean Titers (GMTs) in Maternal Subjects
Day 31
|
9534.2 Titers
Interval 7758.5 to 11716.3
|
10781.2 Titers
Interval 9150.0 to 12703.2
|
799.1 Titers
Interval 622.2 to 1026.2
|
|
RSV-A Neutralizing Antibody Geometric Mean Titers (GMTs) in Maternal Subjects
Delivery
|
6162.1 Titers
Interval 4981.2 to 7623.0
|
6661 Titers
Interval 5490.7 to 8080.7
|
761.1 Titers
Interval 612.1 to 946.3
|
PRIMARY outcome
Timeframe: At delivery or within 3 days after birthPopulation: The analysis was performed on the Per Protocol Set-Infants (PPSI), which included all infant subjects in the ESI who have post-delivery/birth immunogenicity data minus those who (a) were born less than 4 weeks post-maternal subject vaccination and/ or (b) have protocol deviations that lead to exclusion and for whom blood samples were collected at relevant time points.
Serological assays for the determination of IgG antibodies against RSV MAT were performed by ELISA. The corresponding antibody concentrations were expressed in EU/mL. The antibodies were measured on the cord blood sample collected at delivery, or on a blood sample collected from the infant within 3 days after birth (if no cord blood sample could be obtained).
Outcome measures
| Measure |
RSV MAT 60 Group-Mother
n=59 Participants
Maternal subjects randomized to RSV MAT 60 Group received a single dose of RSV MAT (60 µg) vaccine at Day 1, and were followed up until the study end.
|
RSV MAT 120 Group-Mother
n=64 Participants
Maternal subjects randomized to RSV MAT 120 group received a single dose of RSV MAT (120 µg) vaccine at Day 1, and were followed up until the study end.
|
Control Group-Mother
n=60 Participants
Maternal subjects randomized to the Control Group received a single dose of Placebo at Day 1, and were followed up until the study end.
|
|---|---|---|---|
|
RSV MAT IgG Antibody GMCs in Infants Born to Maternal Subjects
|
91606.9 EU/mL
Interval 76414.1 to 109820.3
|
114529.8 EU/mL
Interval 100023.3 to 131140.1
|
9272.3 EU/mL
Interval 7669.8 to 11209.5
|
PRIMARY outcome
Timeframe: At delivery or within 3 days after birthPopulation: The analysis was performed on the PPSI, which included all infant subjects in the ESI who have post-delivery/birth immunogenicity data minus those who (a) were born less than 4 weeks post-maternal subject vaccination and/ or (b) have protocol deviations that lead to exclusion and for whom blood samples were collected at relevant time points.
Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay. The corresponding antibody titers were presented as GMTs, expressed in ED60. The antibodies were measured on the cord blood sample collected at delivery, or on a blood sample collected from the infant within 3 days after birth (if no cord blood sample could be obtained).
Outcome measures
| Measure |
RSV MAT 60 Group-Mother
n=60 Participants
Maternal subjects randomized to RSV MAT 60 Group received a single dose of RSV MAT (60 µg) vaccine at Day 1, and were followed up until the study end.
|
RSV MAT 120 Group-Mother
n=64 Participants
Maternal subjects randomized to RSV MAT 120 group received a single dose of RSV MAT (120 µg) vaccine at Day 1, and were followed up until the study end.
|
Control Group-Mother
n=61 Participants
Maternal subjects randomized to the Control Group received a single dose of Placebo at Day 1, and were followed up until the study end.
|
|---|---|---|---|
|
RSV-A Neutralizing Antibody GMTs in Infants Born to Maternal Subjects
|
8414.7 Titers
Interval 6813.4 to 10392.5
|
10262.5 Titers
Interval 8709.9 to 12091.9
|
1244.7 Titers
Interval 981.3 to 1578.8
|
PRIMARY outcome
Timeframe: At delivery (for maternal subjects) or within 3 days after birth (for infants)Population: The analysis was performed on all pairs of maternal subjects (from PPSM) and their infants (from PPSI) with available results for this outcome measure at the specified time point.
The placental transfer ratio of IgG specific antibody concentration was determined from cord blood (or blood sample collected within 3 days after birth from infants if cord blood was not collected) over that of the blood sample from mother at delivery if blood sample was not collected during delivery). Serological assays for the determination of IgG antibodies against RSV MAT were performed by ELISA.
Outcome measures
| Measure |
RSV MAT 60 Group-Mother
n=59 Participants
Maternal subjects randomized to RSV MAT 60 Group received a single dose of RSV MAT (60 µg) vaccine at Day 1, and were followed up until the study end.
|
RSV MAT 120 Group-Mother
n=63 Participants
Maternal subjects randomized to RSV MAT 120 group received a single dose of RSV MAT (120 µg) vaccine at Day 1, and were followed up until the study end.
|
Control Group-Mother
n=58 Participants
Maternal subjects randomized to the Control Group received a single dose of Placebo at Day 1, and were followed up until the study end.
|
|---|---|---|---|
|
Geometric Mean Ratio Between Cord Blood and Maternal RSV MAT IgG-specific Antibody Concentrations
|
1.62 Ratio
Interval 1.44 to 1.82
|
1.9 Ratio
Interval 1.75 to 2.06
|
1.6 Ratio
Interval 1.47 to 1.75
|
SECONDARY outcome
Timeframe: From Day 1 to Day 181 post-deliveryPopulation: The analysis was performed on the ESM, which included all the maternal subjects who received at least 1 dose of study intervention.
SAEs assessed included any untoward medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity, was a congenital anomaly/birth defect in the offspring of a study subject or abnormal pregnancy outcomes (spontaneous abortion, foetal death, stillbirth, congenital anomalies, ectopic pregnancy), other situations (medical events that might jeopardize the participant or required medical/surgical intervention to prevent one of the other SAEs listed above: e.g. invasive/malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalization). Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination.
Outcome measures
| Measure |
RSV MAT 60 Group-Mother
n=70 Participants
Maternal subjects randomized to RSV MAT 60 Group received a single dose of RSV MAT (60 µg) vaccine at Day 1, and were followed up until the study end.
|
RSV MAT 120 Group-Mother
n=75 Participants
Maternal subjects randomized to RSV MAT 120 group received a single dose of RSV MAT (120 µg) vaccine at Day 1, and were followed up until the study end.
|
Control Group-Mother
n=68 Participants
Maternal subjects randomized to the Control Group received a single dose of Placebo at Day 1, and were followed up until the study end.
|
|---|---|---|---|
|
Percentage of Maternal Subjects With Any SAE From Day 1 to Day 181 Post Delivery
|
22.9 Percentage of maternal subjects
Interval 13.7 to 34.4
|
28 Percentage of maternal subjects
Interval 18.2 to 39.6
|
22.1 Percentage of maternal subjects
Interval 12.9 to 33.8
|
SECONDARY outcome
Timeframe: From Day 1 to Day 181 post-deliveryPopulation: The analysis was performed on the ESM, which included all the maternal subjects who received at least 1 dose of study intervention.
MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Also, for instances where, due to the special circumstances, the subject could not seek medical advice for symptoms/an illness by visiting a medical facility or arranging for a home visit, the subject sought this advice instead via telephone, SMS, email, videotelephony or telemedicine, or other means. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination.
Outcome measures
| Measure |
RSV MAT 60 Group-Mother
n=70 Participants
Maternal subjects randomized to RSV MAT 60 Group received a single dose of RSV MAT (60 µg) vaccine at Day 1, and were followed up until the study end.
|
RSV MAT 120 Group-Mother
n=75 Participants
Maternal subjects randomized to RSV MAT 120 group received a single dose of RSV MAT (120 µg) vaccine at Day 1, and were followed up until the study end.
|
Control Group-Mother
n=68 Participants
Maternal subjects randomized to the Control Group received a single dose of Placebo at Day 1, and were followed up until the study end.
|
|---|---|---|---|
|
Percentage of Maternal Subjects With Any MAE From Day 1 to Day 181 Post Delivery
|
47.1 Percentage of maternal subjects
Interval 35.1 to 59.4
|
53.3 Percentage of maternal subjects
Interval 41.4 to 64.9
|
47.1 Percentage of maternal subjects
Interval 34.8 to 59.6
|
SECONDARY outcome
Timeframe: From Day 1 to Day 181 post-deliveryPopulation: The analysis was performed on the ESM, which included all the maternal subjects who received at least 1 dose of study intervention.
An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs leading to study withdrawal = AEs identified by investigators to cause subject(s) withdrawal until the resolution of the event. These subject withdrawals were considered different from subject withdrawals for other reasons.
Outcome measures
| Measure |
RSV MAT 60 Group-Mother
n=70 Participants
Maternal subjects randomized to RSV MAT 60 Group received a single dose of RSV MAT (60 µg) vaccine at Day 1, and were followed up until the study end.
|
RSV MAT 120 Group-Mother
n=75 Participants
Maternal subjects randomized to RSV MAT 120 group received a single dose of RSV MAT (120 µg) vaccine at Day 1, and were followed up until the study end.
|
Control Group-Mother
n=68 Participants
Maternal subjects randomized to the Control Group received a single dose of Placebo at Day 1, and were followed up until the study end.
|
|---|---|---|---|
|
Percentage of Maternal Subjects With AE Leading to Study Withdrawal From Day 1 to Day 181 Post Delivery
|
0 Percentage of maternal subjects
Interval 0.0 to 0.0
|
0 Percentage of maternal subjects
Interval 0.0 to 0.0
|
0 Percentage of maternal subjects
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: From birth to Day 181 post-birthPopulation: The analysis was performed on the ESI, which included all the infants live-born to exposed maternal subjects, whose parents/LARs completed the informed consent process and signed the informed consent form.
SAEs assessed included any untoward medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity, or is a congenital anomaly/birth defect in the offspring of a study subject, other situations (medical events that might jeopardize the participant or required medical/surgical intervention to prevent one of the other SAEs listed above: e.g. invasive/malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalization). Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination.
Outcome measures
| Measure |
RSV MAT 60 Group-Mother
n=67 Participants
Maternal subjects randomized to RSV MAT 60 Group received a single dose of RSV MAT (60 µg) vaccine at Day 1, and were followed up until the study end.
|
RSV MAT 120 Group-Mother
n=73 Participants
Maternal subjects randomized to RSV MAT 120 group received a single dose of RSV MAT (120 µg) vaccine at Day 1, and were followed up until the study end.
|
Control Group-Mother
n=66 Participants
Maternal subjects randomized to the Control Group received a single dose of Placebo at Day 1, and were followed up until the study end.
|
|---|---|---|---|
|
Percentage of Infant Subjects With Any SAE From Birth to Day 181 Post-birth
|
25.4 Percentage of infant subjects
Interval 15.5 to 37.5
|
28.8 Percentage of infant subjects
Interval 18.8 to 40.6
|
30.3 Percentage of infant subjects
Interval 19.6 to 42.9
|
SECONDARY outcome
Timeframe: From birth to Day 181 post-birthPopulation: The analysis was performed on the ESI, which included all the infants live-born to exposed maternal subjects, whose parents/LARs completed the informed consent process and signed the informed consent form.
An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs leading to study withdrawal = AEs identified by investigators to cause subject(s) withdrawal until the resolution of the event. These subject withdrawals were considered different from subject withdrawals for other reasons.
Outcome measures
| Measure |
RSV MAT 60 Group-Mother
n=67 Participants
Maternal subjects randomized to RSV MAT 60 Group received a single dose of RSV MAT (60 µg) vaccine at Day 1, and were followed up until the study end.
|
RSV MAT 120 Group-Mother
n=73 Participants
Maternal subjects randomized to RSV MAT 120 group received a single dose of RSV MAT (120 µg) vaccine at Day 1, and were followed up until the study end.
|
Control Group-Mother
n=66 Participants
Maternal subjects randomized to the Control Group received a single dose of Placebo at Day 1, and were followed up until the study end.
|
|---|---|---|---|
|
Percentage of Infant Subjects With AE Leading to Study Withdrawal From Birth to Day 181 Post-birth
|
0 Percentage of infant subjects
Interval 0.0 to 0.0
|
0 Percentage of infant subjects
Interval 0.0 to 0.0
|
0 Percentage of infant subjects
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: From birth to Day 181 post-birthPopulation: The analysis was performed on the ESI, which included all the infants live-born to exposed maternal subjects, whose parents/LARs completed the informed consent process and signed the informed consent form.
MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Also, for instances where, due to the special circumstances, the subject could not seek medical advice for symptoms/an illness by visiting a medical facility or arranging for a home visit, the subject sought this advice instead via telephone, SMS, email, videotelephony or telemedicine, or other means. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination.
Outcome measures
| Measure |
RSV MAT 60 Group-Mother
n=67 Participants
Maternal subjects randomized to RSV MAT 60 Group received a single dose of RSV MAT (60 µg) vaccine at Day 1, and were followed up until the study end.
|
RSV MAT 120 Group-Mother
n=73 Participants
Maternal subjects randomized to RSV MAT 120 group received a single dose of RSV MAT (120 µg) vaccine at Day 1, and were followed up until the study end.
|
Control Group-Mother
n=66 Participants
Maternal subjects randomized to the Control Group received a single dose of Placebo at Day 1, and were followed up until the study end.
|
|---|---|---|---|
|
Percentage of Infant Subjects With Any MAE From Birth to Day 181 Post-birth
|
40.3 Percentage of infant subjects
Interval 28.5 to 53.0
|
52.1 Percentage of infant subjects
Interval 40.0 to 63.9
|
39.4 Percentage of infant subjects
Interval 27.6 to 52.2
|
SECONDARY outcome
Timeframe: From birth to Month 12 post-birthPopulation: The analysis was performed on the ESI, which included all the infants live-born to exposed maternal subjects, whose parents/LARs completed the informed consent process and signed the informed consent form.
SAEs assessed included any untoward medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity, or is a congenital anomaly/birth defect in the offspring of a study subject, other situations (medical events that might jeopardize the participant or required medical/surgical intervention to prevent one of the other SAEs listed above: e.g. invasive/malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalization). Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination.
Outcome measures
| Measure |
RSV MAT 60 Group-Mother
n=67 Participants
Maternal subjects randomized to RSV MAT 60 Group received a single dose of RSV MAT (60 µg) vaccine at Day 1, and were followed up until the study end.
|
RSV MAT 120 Group-Mother
n=73 Participants
Maternal subjects randomized to RSV MAT 120 group received a single dose of RSV MAT (120 µg) vaccine at Day 1, and were followed up until the study end.
|
Control Group-Mother
n=66 Participants
Maternal subjects randomized to the Control Group received a single dose of Placebo at Day 1, and were followed up until the study end.
|
|---|---|---|---|
|
Percentage of Infant Subjects With Any SAE From Birth to Month 12 Post-birth
|
25.4 Percentage of infant subjects
Interval 15.5 to 37.5
|
28.8 Percentage of infant subjects
Interval 18.8 to 40.6
|
31.8 Percentage of infant subjects
Interval 20.9 to 44.4
|
SECONDARY outcome
Timeframe: From birth to Month 12 post-birthPopulation: The analysis was performed on the ESI, which included all the infants live-born to exposed maternal subjects, whose parents/LARs completed the informed consent process and signed the informed consent form.
An AE is any untoward medical occurrence in a subject or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs leading to study withdrawal = AEs identified by investigators to cause subject(s) withdrawal until the resolution of the event. These subject withdrawals were considered different from subject withdrawals for other reasons.
Outcome measures
| Measure |
RSV MAT 60 Group-Mother
n=67 Participants
Maternal subjects randomized to RSV MAT 60 Group received a single dose of RSV MAT (60 µg) vaccine at Day 1, and were followed up until the study end.
|
RSV MAT 120 Group-Mother
n=73 Participants
Maternal subjects randomized to RSV MAT 120 group received a single dose of RSV MAT (120 µg) vaccine at Day 1, and were followed up until the study end.
|
Control Group-Mother
n=66 Participants
Maternal subjects randomized to the Control Group received a single dose of Placebo at Day 1, and were followed up until the study end.
|
|---|---|---|---|
|
Percentage of Infant Subjects With Any AE Leading to Study Withdrawal From Birth to Month 12 Post-birth
|
0 Percentage of infant subjects
Interval 0.0 to 0.0
|
0 Percentage of infant subjects
Interval 0.0 to 0.0
|
0 Percentage of infant subjects
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: From birth to Month 12 post-birthPopulation: The analysis was performed on the ESI, which included all the infants live-born to exposed maternal subjects, whose parents/LARs completed the informed consent process and signed the informed consent form.
MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Also, for instances where, due to the special circumstances, the subject could not seek medical advice for symptoms/an illness by visiting a medical facility or arranging for a home visit, the subject sought this advice instead via telephone, SMS, email, videotelephony or telemedicine, or other means. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination.
Outcome measures
| Measure |
RSV MAT 60 Group-Mother
n=67 Participants
Maternal subjects randomized to RSV MAT 60 Group received a single dose of RSV MAT (60 µg) vaccine at Day 1, and were followed up until the study end.
|
RSV MAT 120 Group-Mother
n=73 Participants
Maternal subjects randomized to RSV MAT 120 group received a single dose of RSV MAT (120 µg) vaccine at Day 1, and were followed up until the study end.
|
Control Group-Mother
n=66 Participants
Maternal subjects randomized to the Control Group received a single dose of Placebo at Day 1, and were followed up until the study end.
|
|---|---|---|---|
|
Percentage of Infant Subjects With Any MAE From Birth to Month 12 Post-birth
|
43.3 Percentage of infant subjects
Interval 31.2 to 56.0
|
57.5 Percentage of infant subjects
Interval 45.4 to 69.0
|
43.9 Percentage of infant subjects
Interval 31.7 to 56.7
|
SECONDARY outcome
Timeframe: From delivery to Day 181 post-deliveryPopulation: The analysis was performed on the ESM, which included all the maternal subjects who received at least 1 dose of study intervention.
A maternal MA-RTI occurs when the maternal subject visits a healthcare professional for any respiratory symptom, including cough, sputum production and difficulty breathing. An RSV associated MA-RTI is characterised by a medically attended visit for RTI symptoms (runny nose or blocked nose or cough) and a confirmed RSV infection.
Outcome measures
| Measure |
RSV MAT 60 Group-Mother
n=70 Participants
Maternal subjects randomized to RSV MAT 60 Group received a single dose of RSV MAT (60 µg) vaccine at Day 1, and were followed up until the study end.
|
RSV MAT 120 Group-Mother
n=75 Participants
Maternal subjects randomized to RSV MAT 120 group received a single dose of RSV MAT (120 µg) vaccine at Day 1, and were followed up until the study end.
|
Control Group-Mother
n=68 Participants
Maternal subjects randomized to the Control Group received a single dose of Placebo at Day 1, and were followed up until the study end.
|
|---|---|---|---|
|
Percentage of Maternal Subjects With RSV-associated Medically Attended Respiratory Tract Illnesses (MA-RTI)
|
0 Percentage of maternal subjects
Interval 0.0 to 5.1
|
0 Percentage of maternal subjects
Interval 0.0 to 4.8
|
0 Percentage of maternal subjects
Interval 0.0 to 5.3
|
SECONDARY outcome
Timeframe: From birth to Day 181 post-birthPopulation: The analysis was performed on the ESI, which included all the infants live-born to exposed maternal subjects, whose parents/LARs completed the informed consent process and signed the informed consent form.
An RSV-associated LRTI is characterised by a history of cough or difficulty in breathing, a blood oxygen saturation by pulse oximetry (SpO2) lesser than (\<) 95% or respiratory rate increase and a confirmed RSV infection.
Outcome measures
| Measure |
RSV MAT 60 Group-Mother
n=67 Participants
Maternal subjects randomized to RSV MAT 60 Group received a single dose of RSV MAT (60 µg) vaccine at Day 1, and were followed up until the study end.
|
RSV MAT 120 Group-Mother
n=73 Participants
Maternal subjects randomized to RSV MAT 120 group received a single dose of RSV MAT (120 µg) vaccine at Day 1, and were followed up until the study end.
|
Control Group-Mother
n=66 Participants
Maternal subjects randomized to the Control Group received a single dose of Placebo at Day 1, and were followed up until the study end.
|
|---|---|---|---|
|
Percentage of Infant Subjects With RSV-associated Lower Respiratory Tract Illness (LRTI)
|
0 Percentage of infant subjects
Interval 0.0 to 5.4
|
0 Percentage of infant subjects
Interval 0.0 to 4.9
|
0 Percentage of infant subjects
Interval 0.0 to 5.4
|
SECONDARY outcome
Timeframe: From birth to Day 181 post-birthPopulation: The analysis was performed on the ESI, which included all the infants live-born to exposed maternal subjects, whose parents/LARs completed the informed consent process and signed the informed consent form.
A RSV-associated severe LRTI is characterised by a history of cough or difficulty in breathing, a SpO2 \< 93% or lower chest wall in-drawing and a confirmed RSV infection.
Outcome measures
| Measure |
RSV MAT 60 Group-Mother
n=67 Participants
Maternal subjects randomized to RSV MAT 60 Group received a single dose of RSV MAT (60 µg) vaccine at Day 1, and were followed up until the study end.
|
RSV MAT 120 Group-Mother
n=73 Participants
Maternal subjects randomized to RSV MAT 120 group received a single dose of RSV MAT (120 µg) vaccine at Day 1, and were followed up until the study end.
|
Control Group-Mother
n=66 Participants
Maternal subjects randomized to the Control Group received a single dose of Placebo at Day 1, and were followed up until the study end.
|
|---|---|---|---|
|
Percentage of Infant Subjects With RSV-associated Severe LRTI
|
0 Percentage of infant subjects
Interval 0.0 to 5.4
|
0 Percentage of infant subjects
Interval 0.0 to 4.9
|
0 Percentage of infant subjects
Interval 0.0 to 5.4
|
SECONDARY outcome
Timeframe: From birth to Day 181 post-birthPopulation: The analysis was performed on the ESI, which included all the infants live-born to exposed maternal subjects, whose parents/LARs completed the informed consent process and signed the informed consent form.
A RSV-associated very severe LRTI is characterised by a history of cough or difficulty in breathing, a SpO2 \< 90% or inability to feed or failure to respond/unconscious and a confirmed RSV infection.
Outcome measures
| Measure |
RSV MAT 60 Group-Mother
n=67 Participants
Maternal subjects randomized to RSV MAT 60 Group received a single dose of RSV MAT (60 µg) vaccine at Day 1, and were followed up until the study end.
|
RSV MAT 120 Group-Mother
n=73 Participants
Maternal subjects randomized to RSV MAT 120 group received a single dose of RSV MAT (120 µg) vaccine at Day 1, and were followed up until the study end.
|
Control Group-Mother
n=66 Participants
Maternal subjects randomized to the Control Group received a single dose of Placebo at Day 1, and were followed up until the study end.
|
|---|---|---|---|
|
Percentage of Infant Subjects With RSV-associated Very Severe LRTI
|
0 Percentage of infant subjects
Interval 0.0 to 5.4
|
0 Percentage of infant subjects
Interval 0.0 to 4.9
|
0 Percentage of infant subjects
Interval 0.0 to 5.4
|
SECONDARY outcome
Timeframe: From birth to Day 181 post-birthPopulation: The analysis was performed on the ESI, which included all the infants live-born to exposed maternal subjects, whose parents/LARs completed the informed consent process and signed the informed consent form.
An RSV-associated hospitalisation is characterised by a confirmed RSV infection and a hospitalisation for an acute medical condition.
Outcome measures
| Measure |
RSV MAT 60 Group-Mother
n=67 Participants
Maternal subjects randomized to RSV MAT 60 Group received a single dose of RSV MAT (60 µg) vaccine at Day 1, and were followed up until the study end.
|
RSV MAT 120 Group-Mother
n=73 Participants
Maternal subjects randomized to RSV MAT 120 group received a single dose of RSV MAT (120 µg) vaccine at Day 1, and were followed up until the study end.
|
Control Group-Mother
n=66 Participants
Maternal subjects randomized to the Control Group received a single dose of Placebo at Day 1, and were followed up until the study end.
|
|---|---|---|---|
|
Percentage of Infant Subjects With RSV-associated Hospitalisation
|
0 Percentage of infant subjects
Interval 0.0 to 5.4
|
0 Percentage of infant subjects
Interval 0.0 to 4.9
|
0 Percentage of infant subjects
Interval 0.0 to 5.4
|
SECONDARY outcome
Timeframe: At Day 43 post-deliveryPopulation: The analysis was performed on the PPSM for immunogenicity which included all the maternal subjects who received at least 1 dose of the study intervention to which they were randomized and have post-vaccination data minus those subjects with protocol deviations that lead to exclusion.
Serological assays for the determination of IgG antibodies against RSV MAT were performed by ELISA. The corresponding antibody concentration were expressed in EU/mL.
Outcome measures
| Measure |
RSV MAT 60 Group-Mother
n=53 Participants
Maternal subjects randomized to RSV MAT 60 Group received a single dose of RSV MAT (60 µg) vaccine at Day 1, and were followed up until the study end.
|
RSV MAT 120 Group-Mother
n=59 Participants
Maternal subjects randomized to RSV MAT 120 group received a single dose of RSV MAT (120 µg) vaccine at Day 1, and were followed up until the study end.
|
Control Group-Mother
n=50 Participants
Maternal subjects randomized to the Control Group received a single dose of Placebo at Day 1, and were followed up until the study end.
|
|---|---|---|---|
|
RSV MAT IgG Antibody GMCs in Maternal Subjects, at Day 43 Post-delivery
|
61925 EU/mL
Interval 51966.0 to 73792.0
|
62871 EU/mL
Interval 53878.0 to 73364.0
|
8350 EU/mL
Interval 6723.0 to 10372.0
|
SECONDARY outcome
Timeframe: At Day 43 post-deliveryPopulation: The analysis was performed on the PPSM for immunogenicity which included all the maternal subjects who received at least 1 dose of the study intervention to which they were randomized and have post-vaccination data minus those subjects with protocol deviations that lead to exclusion.
Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay. The corresponding antibody titers were expressed in ED60.
Outcome measures
| Measure |
RSV MAT 60 Group-Mother
n=53 Participants
Maternal subjects randomized to RSV MAT 60 Group received a single dose of RSV MAT (60 µg) vaccine at Day 1, and were followed up until the study end.
|
RSV MAT 120 Group-Mother
n=58 Participants
Maternal subjects randomized to RSV MAT 120 group received a single dose of RSV MAT (120 µg) vaccine at Day 1, and were followed up until the study end.
|
Control Group-Mother
n=50 Participants
Maternal subjects randomized to the Control Group received a single dose of Placebo at Day 1, and were followed up until the study end.
|
|---|---|---|---|
|
RSV-A Neutralizing Antibody GMTs in Maternal Subjects, at Day 43 Post-delivery
|
6451.3 Titers
Interval 4842.4 to 8594.6
|
6290.7 Titers
Interval 5000.6 to 7913.7
|
943.6 Titers
Interval 733.4 to 1213.9
|
SECONDARY outcome
Timeframe: At Day 1 (before vaccination), Day 31, at delivery and Day 43 post-deliveryPopulation: The analysis was performed on the PPSM for immunogenicity which included all the maternal subjects who received at least 1 dose of the study intervention to which they were randomized and have post-vaccination data minus those subjects with protocol deviations that lead to exclusion.
Serological assays for the determination of antibodies against RSV-B are performed by neutralization assay. The corresponding antibody titers were expressed in ED60.
Outcome measures
| Measure |
RSV MAT 60 Group-Mother
n=67 Participants
Maternal subjects randomized to RSV MAT 60 Group received a single dose of RSV MAT (60 µg) vaccine at Day 1, and were followed up until the study end.
|
RSV MAT 120 Group-Mother
n=73 Participants
Maternal subjects randomized to RSV MAT 120 group received a single dose of RSV MAT (120 µg) vaccine at Day 1, and were followed up until the study end.
|
Control Group-Mother
n=68 Participants
Maternal subjects randomized to the Control Group received a single dose of Placebo at Day 1, and were followed up until the study end.
|
|---|---|---|---|
|
RSV-B Neutralizing Antibody GMTs in Maternal Subjects
Day 1
|
1066.3 Titers
Interval 833.7 to 1363.9
|
1144.7 Titers
Interval 933.1 to 1404.4
|
969.5 Titers
Interval 790.5 to 1188.9
|
|
RSV-B Neutralizing Antibody GMTs in Maternal Subjects
Day 31
|
13766.2 Titers
Interval 10692.6 to 17723.2
|
15849.4 Titers
Interval 13101.0 to 19174.4
|
1065.8 Titers
Interval 846.5 to 1341.8
|
|
RSV-B Neutralizing Antibody GMTs in Maternal Subjects
Delivery
|
8983.1 Titers
Interval 7079.7 to 11398.1
|
13335.6 Titers
Interval 10507.0 to 16925.8
|
1190.7 Titers
Interval 922.8 to 1536.5
|
|
RSV-B Neutralizing Antibody GMTs in Maternal Subjects
Day 43 post-delivery
|
12297.7 Titers
Interval 9464.3 to 15979.4
|
10027.2 Titers
Interval 8033.2 to 12516.2
|
1473.8 Titers
Interval 1111.1 to 1954.8
|
SECONDARY outcome
Timeframe: At Day 43 after birthPopulation: The analysis was performed on a subcohort (subcohort V2-New borns) from PPSI, for the subjects who provided sample for this outcome measure at the specified time point.
Serological assays for the determination of IgG antibodies against RSV MAT were performed by ELISA. The corresponding antibody concentration were expressed in EU/mL.
Outcome measures
| Measure |
RSV MAT 60 Group-Mother
n=13 Participants
Maternal subjects randomized to RSV MAT 60 Group received a single dose of RSV MAT (60 µg) vaccine at Day 1, and were followed up until the study end.
|
RSV MAT 120 Group-Mother
n=15 Participants
Maternal subjects randomized to RSV MAT 120 group received a single dose of RSV MAT (120 µg) vaccine at Day 1, and were followed up until the study end.
|
Control Group-Mother
n=11 Participants
Maternal subjects randomized to the Control Group received a single dose of Placebo at Day 1, and were followed up until the study end.
|
|---|---|---|---|
|
RSV MAT IgG Antibody GMCs in Infants Born to Maternal Subjects, at Day 43 After Birth
|
30194.5 EU/mL
Interval 18677.2 to 48813.8
|
39378.2 EU/mL
Interval 33586.7 to 46168.4
|
2576.1 EU/mL
Interval 1566.4 to 4236.5
|
SECONDARY outcome
Timeframe: At Day 121 after birthPopulation: The analysis was performed on a subcohort (subcohort V2-New borns) from PPSI, for the subjects who provided sample for this outcome measure at the specified time point.
Serological assays for the determination of IgG antibodies against RSV MAT were performed by ELISA. The corresponding antibody concentration were expressed in EU/mL.
Outcome measures
| Measure |
RSV MAT 60 Group-Mother
n=17 Participants
Maternal subjects randomized to RSV MAT 60 Group received a single dose of RSV MAT (60 µg) vaccine at Day 1, and were followed up until the study end.
|
RSV MAT 120 Group-Mother
n=19 Participants
Maternal subjects randomized to RSV MAT 120 group received a single dose of RSV MAT (120 µg) vaccine at Day 1, and were followed up until the study end.
|
Control Group-Mother
n=10 Participants
Maternal subjects randomized to the Control Group received a single dose of Placebo at Day 1, and were followed up until the study end.
|
|---|---|---|---|
|
RSV MAT IgG Antibody GMCs in Infants Born to Maternal Subjects, at Day 121 After Birth
|
4292.9 EU/mL
Interval 3263.0 to 5648.0
|
4656.9 EU/mL
Interval 3539.4 to 6127.4
|
445.5 EU/mL
Interval 291.4 to 681.0
|
SECONDARY outcome
Timeframe: At Day 181 after birthPopulation: The analysis was performed on a subcohort (subcohort V2-New borns) from PPSI, for the subjects who provided sample for this outcome measure at the specified time point.
Serological assays for the determination of IgG antibodies against RSV MAT were performed by ELISA. The corresponding antibody concentration were expressed in EU/mL.
Outcome measures
| Measure |
RSV MAT 60 Group-Mother
n=11 Participants
Maternal subjects randomized to RSV MAT 60 Group received a single dose of RSV MAT (60 µg) vaccine at Day 1, and were followed up until the study end.
|
RSV MAT 120 Group-Mother
n=19 Participants
Maternal subjects randomized to RSV MAT 120 group received a single dose of RSV MAT (120 µg) vaccine at Day 1, and were followed up until the study end.
|
Control Group-Mother
n=11 Participants
Maternal subjects randomized to the Control Group received a single dose of Placebo at Day 1, and were followed up until the study end.
|
|---|---|---|---|
|
RSV MAT IgG Antibody GMCs in Infants Born to Maternal Subjects, at Day 181 After Birth
|
1224.1 EU/mL
Interval 815.1 to 1838.4
|
1433.5 EU/mL
Interval 1116.7 to 1840.1
|
179.6 EU/mL
Interval 97.7 to 330.3
|
SECONDARY outcome
Timeframe: At Day 43 after birthPopulation: The analysis was performed on a subcohort (subcohort V2-New borns) from PPSI, for the subjects who provided sample for this outcome measure at the specified time point.
Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay. The corresponding antibody titers were expressed in ED60.
Outcome measures
| Measure |
RSV MAT 60 Group-Mother
n=13 Participants
Maternal subjects randomized to RSV MAT 60 Group received a single dose of RSV MAT (60 µg) vaccine at Day 1, and were followed up until the study end.
|
RSV MAT 120 Group-Mother
n=15 Participants
Maternal subjects randomized to RSV MAT 120 group received a single dose of RSV MAT (120 µg) vaccine at Day 1, and were followed up until the study end.
|
Control Group-Mother
n=11 Participants
Maternal subjects randomized to the Control Group received a single dose of Placebo at Day 1, and were followed up until the study end.
|
|---|---|---|---|
|
RSV-A Neutralizing Antibody GMTs in Infants Born to Maternal Subjects, at Day 43 After Birth
|
3384.2 Titers
Interval 2200.1 to 5205.5
|
3509.6 Titers
Interval 2525.2 to 4877.6
|
613.3 Titers
Interval 298.6 to 1259.8
|
SECONDARY outcome
Timeframe: At Day 121 after birthPopulation: The analysis was performed on a subcohort (subcohort V2-New borns) from PPSI, for the subjects who provided sample for this outcome measure at the specified time point.
Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay. The corresponding antibody titers were expressed in ED60.
Outcome measures
| Measure |
RSV MAT 60 Group-Mother
n=17 Participants
Maternal subjects randomized to RSV MAT 60 Group received a single dose of RSV MAT (60 µg) vaccine at Day 1, and were followed up until the study end.
|
RSV MAT 120 Group-Mother
n=19 Participants
Maternal subjects randomized to RSV MAT 120 group received a single dose of RSV MAT (120 µg) vaccine at Day 1, and were followed up until the study end.
|
Control Group-Mother
n=10 Participants
Maternal subjects randomized to the Control Group received a single dose of Placebo at Day 1, and were followed up until the study end.
|
|---|---|---|---|
|
RSV-A Neutralizing Antibody GMTs in Infants Born to Maternal Subjects, at Day 121 After Birth
|
762.3 Titers
Interval 458.3 to 1268.2
|
890.9 Titers
Interval 648.5 to 1224.0
|
91.2 Titers
Interval 56.8 to 146.5
|
SECONDARY outcome
Timeframe: At Day 181 after birthPopulation: The analysis was performed on a subcohort (subcohort V2-New borns) from PPSI, for the subjects who provided sample for this outcome measure at the specified time point.
Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay. The corresponding antibody titers were expressed in ED60.
Outcome measures
| Measure |
RSV MAT 60 Group-Mother
n=11 Participants
Maternal subjects randomized to RSV MAT 60 Group received a single dose of RSV MAT (60 µg) vaccine at Day 1, and were followed up until the study end.
|
RSV MAT 120 Group-Mother
n=20 Participants
Maternal subjects randomized to RSV MAT 120 group received a single dose of RSV MAT (120 µg) vaccine at Day 1, and were followed up until the study end.
|
Control Group-Mother
n=12 Participants
Maternal subjects randomized to the Control Group received a single dose of Placebo at Day 1, and were followed up until the study end.
|
|---|---|---|---|
|
RSV-A Neutralizing Antibody GMTs in Infants Born to Maternal Subjects, at Day 181 After Birth
|
278.4 Titers
Interval 146.0 to 530.9
|
324.8 Titers
Interval 194.6 to 542.3
|
47.8 Titers
Interval 23.8 to 96.0
|
SECONDARY outcome
Timeframe: At delivery or within 3 days after birthPopulation: The analysis was performed on the Per Protocol Set-Infants (PPSI), which included all infant subjects in the ESI who have post-delivery/birth immunogenicity data minus those who (a) were born less than 4 weeks post- maternal subject vaccination and/ or (b) have protocol deviations that lead to exclusion and for whom blood samples were collected at relevant time points.
Serological assays for the determination of antibodies against RSV-B were performed by neutralization assay. The corresponding antibody titers were expressed in ED60. The antibodies were measured on the cord blood sample collected at delivery, or on a blood sample collected from the infant within 3 days after birth (if no cord blood sample could be obtained).
Outcome measures
| Measure |
RSV MAT 60 Group-Mother
n=58 Participants
Maternal subjects randomized to RSV MAT 60 Group received a single dose of RSV MAT (60 µg) vaccine at Day 1, and were followed up until the study end.
|
RSV MAT 120 Group-Mother
n=64 Participants
Maternal subjects randomized to RSV MAT 120 group received a single dose of RSV MAT (120 µg) vaccine at Day 1, and were followed up until the study end.
|
Control Group-Mother
n=60 Participants
Maternal subjects randomized to the Control Group received a single dose of Placebo at Day 1, and were followed up until the study end.
|
|---|---|---|---|
|
RSV-B Neutralizing Antibody GMTs in Infants Born to Maternal Subjects, at Birth
|
13585.6 Titers
Interval 10453.9 to 17655.4
|
18955 Titers
Interval 15694.7 to 22892.6
|
1656.8 Titers
Interval 1320.3 to 2079.0
|
SECONDARY outcome
Timeframe: At Day 43 after birthPopulation: The analysis was performed on a subcohort (subcohort V2-New borns) from PPSI, for the subjects who provided sample for this outcome measure at the specified time point.
Serological assays for the determination of antibodies against RSV-B were performed by neutralization assay. The corresponding antibody titers were expressed in ED60.
Outcome measures
| Measure |
RSV MAT 60 Group-Mother
n=13 Participants
Maternal subjects randomized to RSV MAT 60 Group received a single dose of RSV MAT (60 µg) vaccine at Day 1, and were followed up until the study end.
|
RSV MAT 120 Group-Mother
n=15 Participants
Maternal subjects randomized to RSV MAT 120 group received a single dose of RSV MAT (120 µg) vaccine at Day 1, and were followed up until the study end.
|
Control Group-Mother
n=11 Participants
Maternal subjects randomized to the Control Group received a single dose of Placebo at Day 1, and were followed up until the study end.
|
|---|---|---|---|
|
RSV-B Neutralizing Antibody GMTs in Infants Born to Maternal Subjects, at Day 43 After Birth
|
5932.1 Titers
Interval 2562.6 to 13731.7
|
6905.5 Titers
Interval 4373.3 to 10903.8
|
548.2 Titers
Interval 292.1 to 1028.8
|
SECONDARY outcome
Timeframe: At Day 121 after birthPopulation: The analysis was performed on a subcohort (subcohort V2-New borns) from PPSI, for the subjects who provided sample for this outcome measure at the specified time point.
Serological assays for the determination of antibodies against RSV-B were performed by neutralization assay. The corresponding antibody titers were expressed in ED60.
Outcome measures
| Measure |
RSV MAT 60 Group-Mother
n=17 Participants
Maternal subjects randomized to RSV MAT 60 Group received a single dose of RSV MAT (60 µg) vaccine at Day 1, and were followed up until the study end.
|
RSV MAT 120 Group-Mother
n=19 Participants
Maternal subjects randomized to RSV MAT 120 group received a single dose of RSV MAT (120 µg) vaccine at Day 1, and were followed up until the study end.
|
Control Group-Mother
n=10 Participants
Maternal subjects randomized to the Control Group received a single dose of Placebo at Day 1, and were followed up until the study end.
|
|---|---|---|---|
|
RSV-B Neutralizing Antibody GMTs in Infants Born to Maternal Subjects, at Day 121 After Birth
|
1119 Titers
Interval 705.3 to 1775.4
|
1367 Titers
Interval 950.5 to 1965.9
|
141.6 Titers
Interval 82.0 to 244.6
|
SECONDARY outcome
Timeframe: At Day 181 after birthPopulation: The analysis was performed on a subcohort (subcohort V2-New borns) from PPSI, for the subjects who provided sample for this outcome measure at the specified time point.
Serological assays for the determination of antibodies against RSV-B were performed by neutralization assay. The corresponding antibody titers were expressed in ED60.
Outcome measures
| Measure |
RSV MAT 60 Group-Mother
n=11 Participants
Maternal subjects randomized to RSV MAT 60 Group received a single dose of RSV MAT (60 µg) vaccine at Day 1, and were followed up until the study end.
|
RSV MAT 120 Group-Mother
n=20 Participants
Maternal subjects randomized to RSV MAT 120 group received a single dose of RSV MAT (120 µg) vaccine at Day 1, and were followed up until the study end.
|
Control Group-Mother
n=12 Participants
Maternal subjects randomized to the Control Group received a single dose of Placebo at Day 1, and were followed up until the study end.
|
|---|---|---|---|
|
RSV-B Neutralizing Antibody GMTs in Infants Born to Maternal Subjects, at Day 181 After Birth
|
459.8 Titers
Interval 245.9 to 859.7
|
574 Titers
Interval 368.9 to 893.3
|
68.8 Titers
Interval 27.1 to 174.7
|
Adverse Events
RSV MAT 60 Group-Mother
Serious events: 16 serious events
Other events: 56 other events
Deaths: 0 deaths
RSV MAT 120 Group-Mother
Serious events: 21 serious events
Other events: 66 other events
Deaths: 0 deaths
Control Group-Mother
Serious events: 15 serious events
Other events: 47 other events
Deaths: 0 deaths
RSV MAT 60 Group-Infant
Serious events: 17 serious events
Other events: 0 other events
Deaths: 0 deaths
RSV MAT 120 Group-Infant
Serious events: 21 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group-Infant
Serious events: 21 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
RSV MAT 60 Group-Mother
n=70 participants at risk
Maternal subjects randomized to RSV MAT 60 Group received a single dose of RSV MAT (60 µg) vaccine at Day 1, and were followed up until the study end.
|
RSV MAT 120 Group-Mother
n=75 participants at risk
Maternal subjects randomized to RSV MAT 120 group received a single dose of RSV MAT (120 µg) vaccine at Day 1, and were followed up until the study end.
|
Control Group-Mother
n=68 participants at risk
Maternal subjects randomized to the Control Group received a single dose of Placebo at Day 1, and were followed up until the study end.
|
RSV MAT 60 Group-Infant
n=67 participants at risk
This group consisted of infants born to mothers (from RSV MAT 60 Group-Mother) who received a single dose of RSV MAT (60 µg) vaccine during pregnancy.
|
RSV MAT 120 Group-Infant
n=73 participants at risk
This group consisted of infants born to mothers (from RSV MAT 120 Group-Mother) who received a single dose of RSV MAT (120 µg) vaccine during pregnancy.
|
Control Group-Infant
n=66 participants at risk
This group consisted of infants born to mothers (from Control Group-Mother) who received a single dose of placebo during pregnancy.
|
|---|---|---|---|---|---|---|
|
Nervous system disorders
Bell's palsy
|
1.4%
1/70 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.3%
1/75 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/67 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/73 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/66 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Injury, poisoning and procedural complications
Post lumbar puncture syndrome
|
0.00%
0/70 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.3%
1/75 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/67 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/73 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/66 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/70 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.3%
1/75 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/67 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/73 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/66 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Vascular disorders
Hypertension
|
1.4%
1/70 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/75 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/67 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/73 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/66 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Congenital, familial and genetic disorders
Congenital naevus
|
0.00%
0/70 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/75 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
6.0%
4/67 • Number of events 4 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
4.1%
3/73 • Number of events 3 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
6.1%
4/66 • Number of events 4 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Congenital, familial and genetic disorders
Ankyloglossia congenital
|
0.00%
0/70 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/75 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/67 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
2.7%
2/73 • Number of events 2 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
4.5%
3/66 • Number of events 3 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Congenital, familial and genetic disorders
Cryptorchism
|
0.00%
0/70 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/75 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/67 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.4%
1/73 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.5%
1/66 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Congenital, familial and genetic disorders
Hypospadias
|
0.00%
0/70 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/75 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/67 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
2.7%
2/73 • Number of events 2 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/66 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Congenital, familial and genetic disorders
Birth mark
|
0.00%
0/70 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/75 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.5%
1/67 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/73 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/66 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Congenital, familial and genetic disorders
Congenital acrochordon
|
0.00%
0/70 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/75 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/67 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/73 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.5%
1/66 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Congenital, familial and genetic disorders
Congenital arterial malformation
|
0.00%
0/70 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/75 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.5%
1/67 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/73 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/66 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Congenital, familial and genetic disorders
Congenital foot malformation
|
0.00%
0/70 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/75 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/67 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/73 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.5%
1/66 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Congenital, familial and genetic disorders
Congenital pneumonia
|
0.00%
0/70 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/75 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/67 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/73 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.5%
1/66 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Congenital, familial and genetic disorders
Congenital skin dimples
|
0.00%
0/70 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/75 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/67 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.4%
1/73 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/66 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Congenital, familial and genetic disorders
Congenital viral hepatitis
|
0.00%
0/70 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/75 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/67 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.4%
1/73 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/66 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Congenital, familial and genetic disorders
Hooded prepuce
|
0.00%
0/70 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/75 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/67 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.4%
1/73 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/66 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Congenital, familial and genetic disorders
Naevus flammeus
|
0.00%
0/70 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/75 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/67 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.4%
1/73 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/66 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Congenital, familial and genetic disorders
Patent ductus arteriosus
|
0.00%
0/70 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/75 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/67 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.4%
1/73 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/66 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Congenital, familial and genetic disorders
Phimosis
|
0.00%
0/70 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/75 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/67 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.4%
1/73 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/66 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Congenital, familial and genetic disorders
Polydactyly
|
0.00%
0/70 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/75 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/67 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/73 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.5%
1/66 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Congenital, familial and genetic disorders
Preauricular cyst
|
0.00%
0/70 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/75 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/67 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/73 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.5%
1/66 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Congenital, familial and genetic disorders
Supernumerary nipple
|
0.00%
0/70 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/75 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/67 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/73 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.5%
1/66 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Congenital, familial and genetic disorders
Ventricular septal defect
|
0.00%
0/70 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/75 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/67 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/73 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.5%
1/66 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal respiratory distress
|
0.00%
0/70 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/75 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
3.0%
2/67 • Number of events 2 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
2.7%
2/73 • Number of events 2 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
6.1%
4/66 • Number of events 4 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Meconium aspiration syndrome
|
1.4%
1/70 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/75 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.5%
1/67 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.4%
1/73 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/66 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Choking
|
0.00%
0/70 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/75 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.5%
1/67 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/73 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/66 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal aspiration
|
0.00%
0/70 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/75 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/67 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/73 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.5%
1/66 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal respiratory depression
|
0.00%
0/70 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/75 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/67 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.4%
1/73 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/66 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal respiratory distress syndrome
|
0.00%
0/70 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/75 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/67 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.4%
1/73 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/66 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal respiratory failure
|
0.00%
0/70 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/75 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/67 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.4%
1/73 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/66 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/70 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/75 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.5%
1/67 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/73 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/66 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Transient tachypnoea of the newborn
|
0.00%
0/70 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/75 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.5%
1/67 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/73 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/66 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Pregnancy, puerperium and perinatal conditions
Foetal distress syndrome
|
2.9%
2/70 • Number of events 2 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
12.0%
9/75 • Number of events 9 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
8.8%
6/68 • Number of events 6 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/67 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/73 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/66 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Pregnancy, puerperium and perinatal conditions
Pre-eclampsia
|
4.3%
3/70 • Number of events 3 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
2.7%
2/75 • Number of events 2 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/67 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/73 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/66 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Pregnancy, puerperium and perinatal conditions
Prolonged labour
|
0.00%
0/70 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
2.7%
2/75 • Number of events 2 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
4.4%
3/68 • Number of events 3 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/67 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/73 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/66 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Pregnancy, puerperium and perinatal conditions
Foetal growth restriction
|
1.4%
1/70 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
4.0%
3/75 • Number of events 3 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/67 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/73 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/66 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Pregnancy, puerperium and perinatal conditions
Oligohydramnios
|
2.9%
2/70 • Number of events 2 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.3%
1/75 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.5%
1/68 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/67 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/73 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/66 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Pregnancy, puerperium and perinatal conditions
Gestational hypertension
|
2.9%
2/70 • Number of events 2 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/75 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.5%
1/68 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/67 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/73 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/66 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Pregnancy, puerperium and perinatal conditions
Premature labour
|
0.00%
0/70 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.3%
1/75 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
2.9%
2/68 • Number of events 2 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/67 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/73 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/66 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Pregnancy, puerperium and perinatal conditions
Obstructed labour
|
0.00%
0/70 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.3%
1/75 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.5%
1/68 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/67 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/73 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/66 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Pregnancy, puerperium and perinatal conditions
Premature delivery
|
0.00%
0/70 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
2.7%
2/75 • Number of events 2 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/67 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/73 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/66 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Pregnancy, puerperium and perinatal conditions
Preterm premature rupture of membranes
|
1.4%
1/70 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/75 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.5%
1/68 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/67 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/73 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/66 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Pregnancy, puerperium and perinatal conditions
Arrested labour
|
0.00%
0/70 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.3%
1/75 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/67 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/73 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/66 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Pregnancy, puerperium and perinatal conditions
Breech presentation
|
0.00%
0/70 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.3%
1/75 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/67 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/73 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/66 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Pregnancy, puerperium and perinatal conditions
Foetal cardiac disorder
|
0.00%
0/70 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.3%
1/75 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/67 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/73 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/66 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Pregnancy, puerperium and perinatal conditions
Prolonged rupture of membranes
|
0.00%
0/70 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/75 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.5%
1/68 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/67 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/73 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/66 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Pregnancy, puerperium and perinatal conditions
Stillbirth
|
0.00%
0/70 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/75 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.5%
1/68 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/67 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/73 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/66 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Pregnancy, puerperium and perinatal conditions
Umbilical cord compression
|
0.00%
0/70 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.3%
1/75 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/67 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/73 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/66 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Pregnancy, puerperium and perinatal conditions
Premature baby
|
0.00%
0/70 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/75 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.5%
1/67 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
4.1%
3/73 • Number of events 3 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.5%
1/66 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Pregnancy, puerperium and perinatal conditions
Jaundice neonatal
|
0.00%
0/70 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/75 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.5%
1/67 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.4%
1/73 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
3.0%
2/66 • Number of events 2 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Pregnancy, puerperium and perinatal conditions
Low birth weight baby
|
0.00%
0/70 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/75 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/67 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.4%
1/73 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/66 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/70 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/75 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.5%
1/67 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
2.7%
2/73 • Number of events 2 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/66 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/70 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/75 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/67 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.4%
1/73 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/66 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/70 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/75 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/67 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.4%
1/73 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/66 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Gastrointestinal disorders
Meconium ileus
|
0.00%
0/70 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/75 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/67 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.4%
1/73 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/66 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Skin and subcutaneous tissue disorders
Macule
|
0.00%
0/70 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/75 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
3.0%
2/67 • Number of events 3 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/73 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.5%
1/66 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.00%
0/70 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/75 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/67 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/73 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.5%
1/66 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Infections and infestations
Amniotic cavity infection
|
1.4%
1/70 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
2.7%
2/75 • Number of events 2 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/67 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/73 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/66 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Infections and infestations
Mastitis
|
1.4%
1/70 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/75 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.5%
1/68 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/67 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/73 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/66 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Infections and infestations
Breast abscess
|
0.00%
0/70 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/75 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.5%
1/68 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/67 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/73 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/66 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Infections and infestations
Influenza
|
0.00%
0/70 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/75 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.5%
1/68 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/67 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/73 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/66 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Infections and infestations
Neonatal pneumonia
|
1.4%
1/70 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/75 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/67 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/73 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/66 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Infections and infestations
Pyelonephritis
|
1.4%
1/70 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/75 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/67 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/73 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/66 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/70 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/75 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/67 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/73 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.5%
1/66 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Infections and infestations
Meningitis viral
|
0.00%
0/70 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/75 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/67 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.4%
1/73 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/66 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Infections and infestations
Sepsis neonatal
|
0.00%
0/70 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/75 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/67 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.4%
1/73 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/66 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/70 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/75 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/67 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.4%
1/73 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/66 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Hepatobiliary disorders
Cholestasis of pregnancy
|
1.4%
1/70 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/75 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/67 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/73 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/66 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/70 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/75 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/67 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.4%
1/73 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/66 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia neonatal
|
0.00%
0/70 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/75 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/67 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.4%
1/73 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/66 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Hepatobiliary disorders
Neonatal cholestasis
|
0.00%
0/70 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/75 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/67 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.4%
1/73 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/66 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of skin
|
0.00%
0/70 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/75 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/67 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/73 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.5%
1/66 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Infantile haemangioma
|
0.00%
0/70 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/75 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.5%
1/67 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/73 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/66 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Investigations
Cardiac murmur
|
0.00%
0/70 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/75 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/67 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/73 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.5%
1/66 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Renal and urinary disorders
Pelvi-ureteric obstruction
|
0.00%
0/70 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/75 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/67 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/73 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.5%
1/66 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Eye disorders
Dacryostenosis acquired
|
0.00%
0/70 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/75 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.5%
1/67 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/73 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/66 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Blood and lymphatic system disorders
Anaemia neonatal
|
0.00%
0/70 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/75 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/67 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.4%
1/73 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/66 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Cardiac disorders
Cardiomegaly
|
0.00%
0/70 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/75 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/67 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.4%
1/73 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/66 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
General disorders
Cyst
|
0.00%
0/70 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/75 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/67 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.4%
1/73 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/66 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
Other adverse events
| Measure |
RSV MAT 60 Group-Mother
n=70 participants at risk
Maternal subjects randomized to RSV MAT 60 Group received a single dose of RSV MAT (60 µg) vaccine at Day 1, and were followed up until the study end.
|
RSV MAT 120 Group-Mother
n=75 participants at risk
Maternal subjects randomized to RSV MAT 120 group received a single dose of RSV MAT (120 µg) vaccine at Day 1, and were followed up until the study end.
|
Control Group-Mother
n=68 participants at risk
Maternal subjects randomized to the Control Group received a single dose of Placebo at Day 1, and were followed up until the study end.
|
RSV MAT 60 Group-Infant
n=67 participants at risk
This group consisted of infants born to mothers (from RSV MAT 60 Group-Mother) who received a single dose of RSV MAT (60 µg) vaccine during pregnancy.
|
RSV MAT 120 Group-Infant
n=73 participants at risk
This group consisted of infants born to mothers (from RSV MAT 120 Group-Mother) who received a single dose of RSV MAT (120 µg) vaccine during pregnancy.
|
Control Group-Infant
n=66 participants at risk
This group consisted of infants born to mothers (from Control Group-Mother) who received a single dose of placebo during pregnancy.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/70 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.3%
1/75 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Nervous system disorders
Headache
|
35.7%
25/70 • Number of events 25 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
28.0%
21/75 • Number of events 23 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
20.6%
14/68 • Number of events 14 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Gastrointestinal disorders
Nausea
|
25.7%
18/70 • Number of events 18 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
22.7%
17/75 • Number of events 17 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
13.2%
9/68 • Number of events 9 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
12.9%
9/70 • Number of events 9 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
22.7%
17/75 • Number of events 18 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
10.3%
7/68 • Number of events 9 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
15.7%
11/70 • Number of events 11 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
17.3%
13/75 • Number of events 13 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
13.2%
9/68 • Number of events 9 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Gastrointestinal disorders
Vomiting
|
7.1%
5/70 • Number of events 5 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
9.3%
7/75 • Number of events 7 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
5.9%
4/68 • Number of events 4 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/70 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.3%
1/75 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.5%
1/68 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
1.4%
1/70 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/75 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/70 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.3%
1/75 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Gastrointestinal disorders
Constipation
|
1.4%
1/70 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/75 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/70 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.3%
1/75 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/70 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.3%
1/75 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Gastrointestinal disorders
Mouth cyst
|
0.00%
0/70 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.3%
1/75 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Gastrointestinal disorders
Teething
|
1.4%
1/70 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/75 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Nervous system disorders
Dizziness
|
2.9%
2/70 • Number of events 2 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/75 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.5%
1/68 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Nervous system disorders
Migraine
|
0.00%
0/70 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/75 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.5%
1/68 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/70 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.3%
1/75 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
5.9%
4/68 • Number of events 4 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Infections and infestations
Urinary tract infection
|
2.9%
2/70 • Number of events 2 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.3%
1/75 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
2.9%
2/68 • Number of events 2 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Infections and infestations
Influenza
|
0.00%
0/70 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
4.0%
3/75 • Number of events 3 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.5%
1/68 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/70 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
2.7%
2/75 • Number of events 2 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.5%
1/68 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/70 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/75 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.5%
1/68 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Infections and infestations
Asymptomatic bacteriuria
|
0.00%
0/70 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/75 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.5%
1/68 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Infections and infestations
Beta haemolytic streptococcal infection
|
1.4%
1/70 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/75 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/70 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/75 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.5%
1/68 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Infections and infestations
Hordeolum
|
1.4%
1/70 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/75 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Infections and infestations
Respiratory tract infection
|
1.4%
1/70 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/75 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/70 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.3%
1/75 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.4%
1/70 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
4.0%
3/75 • Number of events 3 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
2.9%
2/68 • Number of events 2 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.4%
1/70 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.3%
1/75 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.5%
1/68 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.4%
1/70 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.3%
1/75 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.4%
1/70 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/75 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Asthmatic crisis
|
0.00%
0/70 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/75 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.5%
1/68 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
1.4%
1/70 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/75 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/70 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/75 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.5%
1/68 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/70 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.3%
1/75 • Number of events 2 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.4%
1/70 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
4.0%
3/75 • Number of events 3 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.4%
1/70 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/75 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.5%
1/68 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.4%
1/70 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/75 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
1.4%
1/70 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/75 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Musculoskeletal and connective tissue disorders
Ligament pain
|
1.4%
1/70 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/75 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Pregnancy, puerperium and perinatal conditions
Foetal hypokinesia
|
1.4%
1/70 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/75 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.5%
1/68 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
General disorders
Injection site pain
|
57.1%
40/70 • Number of events 40 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
52.0%
39/75 • Number of events 39 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
14.7%
10/68 • Number of events 10 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
General disorders
Fatigue
|
40.0%
28/70 • Number of events 28 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
34.7%
26/75 • Number of events 28 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
25.0%
17/68 • Number of events 17 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
General disorders
Injection site erythema
|
1.4%
1/70 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
6.7%
5/75 • Number of events 5 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
General disorders
Injection site swelling
|
4.3%
3/70 • Number of events 3 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
4.0%
3/75 • Number of events 3 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
General disorders
Oedema peripheral
|
2.9%
2/70 • Number of events 2 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/75 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.5%
1/68 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
General disorders
Influenza like illness
|
1.4%
1/70 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.3%
1/75 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
General disorders
Asthenia
|
0.00%
0/70 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/75 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.5%
1/68 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
General disorders
Feeling hot
|
0.00%
0/70 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/75 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.5%
1/68 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
General disorders
Induration
|
1.4%
1/70 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/75 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
General disorders
Injection site irritation
|
0.00%
0/70 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.3%
1/75 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
General disorders
Malaise
|
1.4%
1/70 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/75 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
General disorders
Swelling
|
1.4%
1/70 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/75 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Pregnancy, puerperium and perinatal conditions
Uterine contractions during pregnancy
|
0.00%
0/70 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
2.7%
2/75 • Number of events 2 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Pregnancy, puerperium and perinatal conditions
Gestational diabetes
|
1.4%
1/70 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/75 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/70 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.3%
1/75 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.5%
1/68 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Psychiatric disorders
Depression
|
1.4%
1/70 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/75 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Hepatobiliary disorders
Cholestasis of pregnancy
|
1.4%
1/70 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.3%
1/75 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
1.4%
1/70 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/75 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Reproductive system and breast disorders
Vulvovaginal discomfort
|
0.00%
0/70 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.3%
1/75 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Renal and urinary disorders
Glycosuria
|
0.00%
0/70 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.3%
1/75 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/70 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.3%
1/75 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/70 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/75 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.5%
1/68 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Eye disorders
Vision blurred
|
1.4%
1/70 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/75 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Blood and lymphatic system disorders
Anaemia of pregnancy
|
0.00%
0/70 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.3%
1/75 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/70 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.3%
1/75 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/70 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
1.3%
1/75 • Number of events 1 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
0.00%
0/68 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
—
0/0 • For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER