Trial Outcomes & Findings for A Trial Evaluating a 7-valent Pneumococcal Conjugate Vaccine Given With Diphtheria, Tetanus, and Acellular Pertussis Vaccine (DTaP) in Healthy Japanese Infants. (NCT NCT01250756)
NCT ID: NCT01250756
Last Updated: 2013-02-26
Results Overview
Percentage of participants achieving predefined antibody level along with the corresponding 95% confidence interval (CI) were presented. Exact 2-sided CI based on the observed proportion of participants. Predefined antibody levels were 0.1 International Units/mL (IU/mL) for diphtheria, 0.01 IU/mL for tetanus, 5 Enzyme-linked Immunosorbent Assay (ELISA) units/mL (EU/mL) for pertussis toxoid (PT), and 5 EU/mL for filamentous hemagglutinin (FHA).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
321 participants
Primary outcome timeframe
1 month after the infant series
Results posted on
2013-02-26
Participant Flow
Participant milestones
| Measure |
7vPnC + DTaP
Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
|
DTaP (Catch-up 7vPnC)
Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
|
|---|---|---|
|
Infant Series
STARTED
|
161
|
160
|
|
Infant Series
Vaccinated Dose 1
|
159
|
158
|
|
Infant Series
Vaccinated Dose 2
|
147
|
157
|
|
Infant Series
Vaccinated Dose 3
|
133
|
155
|
|
Infant Series
COMPLETED
|
133
|
153
|
|
Infant Series
NOT COMPLETED
|
28
|
7
|
|
After Infant Series
STARTED
|
133
|
153
|
|
After Infant Series
COMPLETED
|
122
|
149
|
|
After Infant Series
NOT COMPLETED
|
11
|
4
|
|
Toddler Dose
STARTED
|
122
|
149
|
|
Toddler Dose
COMPLETED
|
122
|
148
|
|
Toddler Dose
NOT COMPLETED
|
0
|
1
|
|
After Toddler Dose
STARTED
|
0
|
148
|
|
After Toddler Dose
COMPLETED
|
0
|
147
|
|
After Toddler Dose
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
7vPnC + DTaP
Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
|
DTaP (Catch-up 7vPnC)
Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
|
|---|---|---|
|
Infant Series
Withdrawal by Subject
|
4
|
5
|
|
Infant Series
Randomized, Not Vaccinated
|
2
|
2
|
|
Infant Series
Other
|
22
|
0
|
|
After Infant Series
Adverse Event
|
5
|
2
|
|
After Infant Series
Withdrawal by Subject
|
4
|
1
|
|
After Infant Series
Other
|
2
|
1
|
|
Toddler Dose
Adverse Event
|
0
|
1
|
|
After Toddler Dose
Adverse Event
|
0
|
1
|
Baseline Characteristics
A Trial Evaluating a 7-valent Pneumococcal Conjugate Vaccine Given With Diphtheria, Tetanus, and Acellular Pertussis Vaccine (DTaP) in Healthy Japanese Infants.
Baseline characteristics by cohort
| Measure |
7vPnC + DTaP
n=161 Participants
Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
|
DTaP (Catch-up 7vPnC)
n=160 Participants
Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
|
Total
n=321 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
3.8 months
STANDARD_DEVIATION 0.91 • n=5 Participants
|
3.9 months
STANDARD_DEVIATION 0.94 • n=7 Participants
|
3.9 months
STANDARD_DEVIATION 0.93 • n=5 Participants
|
|
Sex: Female, Male
Female
|
80 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
162 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
81 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
159 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 month after the infant seriesPopulation: Evaluable infant immunogenicity population: eligible participants who received the vaccine to which they were randomized at all 3 doses, had blood drawn within the protocol-specified time frames, had at least 1 valid, determinate assay result for proposed analysis, received no prohibited vaccines, and had no major protocol violations.
Percentage of participants achieving predefined antibody level along with the corresponding 95% confidence interval (CI) were presented. Exact 2-sided CI based on the observed proportion of participants. Predefined antibody levels were 0.1 International Units/mL (IU/mL) for diphtheria, 0.01 IU/mL for tetanus, 5 Enzyme-linked Immunosorbent Assay (ELISA) units/mL (EU/mL) for pertussis toxoid (PT), and 5 EU/mL for filamentous hemagglutinin (FHA).
Outcome measures
| Measure |
7vPnC + DTaP
n=132 Participants
Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
|
DTaP (Catch-up 7vPnC)
n=149 Participants
Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
|
|---|---|---|
|
Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Infant Series
Diphtheria
|
100.0 Percentage of participants
Interval 97.2 to 100.0
|
100.0 Percentage of participants
Interval 97.6 to 100.0
|
|
Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Infant Series
Tetanus
|
100.0 Percentage of participants
Interval 97.2 to 100.0
|
100.0 Percentage of participants
Interval 97.6 to 100.0
|
|
Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Infant Series
Pertussis toxoid (PT)
|
100.0 Percentage of participants
Interval 97.2 to 100.0
|
100.0 Percentage of participants
Interval 97.6 to 100.0
|
|
Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Infant Series
Filamentous hemagglutinin (FHA)
|
100.0 Percentage of participants
Interval 97.2 to 100.0
|
100.0 Percentage of participants
Interval 97.6 to 100.0
|
PRIMARY outcome
Timeframe: 1 month after the infant seriesPopulation: Evaluable infant immunogenicity population: eligible participants who received the vaccine to which they were randomized at all 3 doses, had blood drawn within the protocol-specified time frames, had at least 1 valid, determinate assay result for proposed analysis, received no prohibited vaccines, and had no major protocol violations.
Geometric mean concentrations (GMCs) were measured in IU/mL and corresponding 2-sided 95% confidence interval (CI) were evaluated for diphtheria and tetanus antibodies.
Outcome measures
| Measure |
7vPnC + DTaP
n=132 Participants
Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
|
DTaP (Catch-up 7vPnC)
n=149 Participants
Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
|
|---|---|---|
|
Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibody 1 Month After the Infant Series
Diphtheria
|
1.38 IU/mL
Interval 1.27 to 1.49
|
0.99 IU/mL
Interval 0.91 to 1.09
|
|
Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibody 1 Month After the Infant Series
Tetanus
|
1.91 IU/mL
Interval 1.69 to 2.16
|
2.05 IU/mL
Interval 1.83 to 2.29
|
PRIMARY outcome
Timeframe: 1 month after the infant seriesPopulation: Evaluable infant immunogenicity population: eligible participants who received the vaccine to which they were randomized at all 3 doses, had blood drawn within the protocol-specified time frames, had at least 1 valid, determinate assay result for proposed analysis, received no prohibited vaccines, and had no major protocol violations.
GMCs were measured in EU/mL and corresponding 2-sided 95% CI were evaluated for PT and FHA antibodies.
Outcome measures
| Measure |
7vPnC + DTaP
n=132 Participants
Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
|
DTaP (Catch-up 7vPnC)
n=149 Participants
Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
|
|---|---|---|
|
Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibody 1 Month After the Infant Series
Pertussis toxoid (PT)
|
76.79 EU/mL
Interval 70.81 to 83.28
|
83.56 EU/mL
Interval 77.54 to 90.05
|
|
Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibody 1 Month After the Infant Series
Filamentous hemagglutinin (FHA)
|
72.89 EU/mL
Interval 65.8 to 80.74
|
77.85 EU/mL
Interval 71.01 to 85.35
|
PRIMARY outcome
Timeframe: 1 month after the infant seriesPopulation: Evaluable infant immunogenicity population: eligible participants who received the vaccine to which they were randomized at all 3 doses, had blood drawn within the protocol-specified time frames, had at least 1 valid, determinate assay result for proposed analysis, received no prohibited vaccines, and had no major protocol violations.
Percentage of participants achieving predefined antibody threshold \>=0.35 mcg/mL along with the corresponding 95% CI for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) were presented. Exact 2-sided CI based on the observed proportion of participants.
Outcome measures
| Measure |
7vPnC + DTaP
n=132 Participants
Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
|
DTaP (Catch-up 7vPnC)
Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
|
|---|---|---|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series
4
|
100.0 Percentage of participants
Interval 97.2 to 100.0
|
—
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series
6B
|
99.2 Percentage of participants
Interval 95.9 to 100.0
|
—
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series
9V
|
100.0 Percentage of participants
Interval 97.2 to 100.0
|
—
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series
14
|
99.2 Percentage of participants
Interval 95.9 to 100.0
|
—
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series
18C
|
99.2 Percentage of participants
Interval 95.8 to 100.0
|
—
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series
19F
|
97.7 Percentage of participants
Interval 93.5 to 99.5
|
—
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series
23F
|
98.5 Percentage of participants
Interval 94.6 to 99.8
|
—
|
PRIMARY outcome
Timeframe: 1 month after the infant seriesPopulation: Evaluable infant immunogenicity population: eligible participants who received the vaccine to which they were randomized at all 3 doses, had blood drawn within the protocol-specified time frames, had at least 1 valid, determinate assay result for proposed analysis, received no prohibited vaccines, and had no major protocol violations.
Antibody geometric mean concentrations (GMCs) for 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) were presented. GMC and corresponding 2-sided 95% CI were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.
Outcome measures
| Measure |
7vPnC + DTaP
n=132 Participants
Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
|
DTaP (Catch-up 7vPnC)
Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
|
|---|---|---|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series
4
|
11.82 mcg/mL
Interval 10.5 to 13.31
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series
6B
|
4.23 mcg/mL
Interval 3.61 to 4.97
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series
9V
|
5.96 mcg/mL
Interval 5.37 to 6.62
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series
14
|
16.61 mcg/mL
Interval 14.66 to 18.81
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series
18C
|
5.48 mcg/mL
Interval 4.76 to 6.31
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series
19F
|
8.85 mcg/mL
Interval 7.54 to 10.4
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series
23F
|
4.17 mcg/mL
Interval 3.54 to 4.91
|
—
|
SECONDARY outcome
Timeframe: 1 month after the toddler dosePopulation: Evaluable toddler immunogenicity set: eligible participants who received vaccine to which they were randomized at all 4 doses, had blood drawn within protocol-specified time, had at least 1 valid, determinate assay result after toddler dose for analysis, received no prohibited vaccines, and had no major protocol violations.
Percentage of participants achieving predefined antibody level along with the corresponding 95% CI were presented. Exact 2-sided CI based on the observed proportion of participants. Predefined antibody levels were 0.1 IU/mL for diphtheria, 0.01 IU/mL for tetanus, 5 EU/mL for PT, and 5 EU/mL for FHA.
Outcome measures
| Measure |
7vPnC + DTaP
n=121 Participants
Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
|
DTaP (Catch-up 7vPnC)
n=146 Participants
Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
|
|---|---|---|
|
Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Toddler Dose
Diphtheria
|
100.0 Percentage of participants
Interval 97.0 to 100.0
|
100.0 Percentage of participants
Interval 97.5 to 100.0
|
|
Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Toddler Dose
Tetanus
|
100.0 Percentage of participants
Interval 97.0 to 100.0
|
100.0 Percentage of participants
Interval 97.5 to 100.0
|
|
Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Toddler Dose
Pertussis toxoid (PT)
|
100.0 Percentage of participants
Interval 97.0 to 100.0
|
100.0 Percentage of participants
Interval 97.5 to 100.0
|
|
Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Toddler Dose
Filamentous hemagglutinin (FHA)
|
100.0 Percentage of participants
Interval 97.0 to 100.0
|
100.0 Percentage of participants
Interval 97.5 to 100.0
|
SECONDARY outcome
Timeframe: 1 month after the toddler dosePopulation: Evaluable toddler immunogenicity set: eligible participants who received vaccine to which they were randomized at all 4 doses, had blood drawn within protocol-specified time, had at least 1 valid, determinate assay result after toddler dose for analysis, received no prohibited vaccines, and had no major protocol violations.
GMCs were measured in IU/mL and corresponding 2-sided 95% CI were evaluated for diphtheria and tetanus antibodies.
Outcome measures
| Measure |
7vPnC + DTaP
n=121 Participants
Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
|
DTaP (Catch-up 7vPnC)
n=146 Participants
Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
|
|---|---|---|
|
Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibody 1 Month After the Toddler Dose
Diphtheria
|
2.56 IU/mL
Interval 2.35 to 2.78
|
2.14 IU/mL
Interval 1.94 to 2.35
|
|
Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibody 1 Month After the Toddler Dose
Tetanus
|
2.53 IU/mL
Interval 2.26 to 2.82
|
3.04 IU/mL
Interval 2.74 to 3.38
|
SECONDARY outcome
Timeframe: 1 month after the toddler dosePopulation: Evaluable toddler immunogenicity set: eligible participants who received vaccine to which they were randomized at all 4 doses, had blood drawn within protocol-specified time, had at least 1 valid, determinate assay result after toddler dose for analysis, received no prohibited vaccines, and had no major protocol violations.
GMCs were measured in EU/mL and corresponding 2-sided 95% CI were evaluated for PT and FHA antibodies.
Outcome measures
| Measure |
7vPnC + DTaP
n=121 Participants
Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
|
DTaP (Catch-up 7vPnC)
n=146 Participants
Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
|
|---|---|---|
|
Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibody 1 Month After the Toddler Dose
PT
|
106.54 EU/mL
Interval 96.1 to 118.12
|
130.62 EU/mL
Interval 119.6 to 142.65
|
|
Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibody 1 Month After the Toddler Dose
FHA
|
120.99 EU/mL
Interval 109.75 to 133.39
|
145.38 EU/mL
Interval 132.41 to 159.63
|
SECONDARY outcome
Timeframe: 1 month after the toddler dosePopulation: Evaluable toddler immunogenicity set: eligible participants who received vaccine to which they were randomized at all 4 doses, had blood drawn within protocol-specified time, had at least 1 valid, determinate assay result after toddler dose for analysis, received no prohibited vaccines, and had no major protocol violations.
Percentage of participants achieving predefined antibody threshold \>=0.35 mcg/mL along with the corresponding 95% CI for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) were presented. Exact 2-sided CI based on the observed proportion of participants.
Outcome measures
| Measure |
7vPnC + DTaP
n=121 Participants
Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
|
DTaP (Catch-up 7vPnC)
Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
|
|---|---|---|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 Mcg/mL 1 Month After the Toddler Dose
4
|
100.0 Percentage of participants
Interval 97.0 to 100.0
|
—
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 Mcg/mL 1 Month After the Toddler Dose
6B
|
100.0 Percentage of participants
Interval 97.0 to 100.0
|
—
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 Mcg/mL 1 Month After the Toddler Dose
9V
|
100.0 Percentage of participants
Interval 97.0 to 100.0
|
—
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 Mcg/mL 1 Month After the Toddler Dose
14
|
100.0 Percentage of participants
Interval 97.0 to 100.0
|
—
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 Mcg/mL 1 Month After the Toddler Dose
18C
|
99.2 Percentage of participants
Interval 95.5 to 100.0
|
—
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 Mcg/mL 1 Month After the Toddler Dose
19F
|
99.2 Percentage of participants
Interval 95.5 to 100.0
|
—
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 Mcg/mL 1 Month After the Toddler Dose
23F
|
100.0 Percentage of participants
Interval 97.0 to 100.0
|
—
|
SECONDARY outcome
Timeframe: 1 month after the toddler dosePopulation: Evaluable toddler immunogenicity set: eligible participants who received vaccine to which they were randomized at all 4 doses, had blood drawn within protocol-specified time, had at least 1 valid, determinate assay result after toddler dose for analysis, received no prohibited vaccines, and had no major protocol violations.
Antibody GMCs for 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) were presented. GMC and corresponding 2-sided 95% CIs were evaluated. GMs were calculated using all participants with available data for the specified blood draw.
Outcome measures
| Measure |
7vPnC + DTaP
n=121 Participants
Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
|
DTaP (Catch-up 7vPnC)
Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
|
|---|---|---|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose
19F
|
9.70 mcg/mL
Interval 8.15 to 11.56
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose
4
|
12.15 mcg/mL
Interval 10.35 to 14.26
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose
6B
|
10.66 mcg/mL
Interval 8.96 to 12.68
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose
9V
|
6.43 mcg/mL
Interval 5.57 to 7.42
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose
14
|
15.83 mcg/mL
Interval 13.81 to 18.14
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose
18C
|
6.53 mcg/mL
Interval 5.49 to 7.76
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose
23F
|
10.17 mcg/mL
Interval 8.58 to 12.07
|
—
|
SECONDARY outcome
Timeframe: Pre-toddler dose, 1 month after the toddler dosePopulation: Evaluable toddler immunogenicity set: eligible participants who received vaccine to which they were randomized at all 4 doses, had blood drawn within protocol-specified time, had at least 1 valid, determinate assay result after toddler dose for analysis, received no prohibited vaccines, and had no major protocol violations.
Geometric mean fold rises (GMFRs) for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) from prevaccination to 1 month postvaccination were computed using the logarithmically transformed assay results. CI for the GMFRs were back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.
Outcome measures
| Measure |
7vPnC + DTaP
n=121 Participants
Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
|
DTaP (Catch-up 7vPnC)
Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
|
|---|---|---|
|
Geometric Mean Fold Rise (GMFR) of Pneumococcal Antibodies From Pretoddler Dose to 1 Month After the Toddler Dose
4
|
6.74 Fold Rise
Interval 5.75 to 7.9
|
—
|
|
Geometric Mean Fold Rise (GMFR) of Pneumococcal Antibodies From Pretoddler Dose to 1 Month After the Toddler Dose
6B
|
5.89 Fold Rise
Interval 5.09 to 6.81
|
—
|
|
Geometric Mean Fold Rise (GMFR) of Pneumococcal Antibodies From Pretoddler Dose to 1 Month After the Toddler Dose
9V
|
4.34 Fold Rise
Interval 3.81 to 4.93
|
—
|
|
Geometric Mean Fold Rise (GMFR) of Pneumococcal Antibodies From Pretoddler Dose to 1 Month After the Toddler Dose
14
|
3.63 Fold Rise
Interval 3.22 to 4.09
|
—
|
|
Geometric Mean Fold Rise (GMFR) of Pneumococcal Antibodies From Pretoddler Dose to 1 Month After the Toddler Dose
18C
|
6.90 Fold Rise
Interval 6.06 to 7.85
|
—
|
|
Geometric Mean Fold Rise (GMFR) of Pneumococcal Antibodies From Pretoddler Dose to 1 Month After the Toddler Dose
19F
|
6.37 Fold Rise
Interval 5.35 to 7.59
|
—
|
|
Geometric Mean Fold Rise (GMFR) of Pneumococcal Antibodies From Pretoddler Dose to 1 Month After the Toddler Dose
23F
|
8.10 Fold Rise
Interval 7.01 to 9.35
|
—
|
SECONDARY outcome
Timeframe: 1 month after the catch-up dose 3Population: Catch-up immunogenicity population: eligible participants who received the vaccine to which they were randomized at all 3 catch-up doses, had blood drawn within the protocol-specified time frames, had at least 1 valid, determinate assay result for proposed analysis, received no prohibited vaccines, and had no major protocol violations.
Percentage of participants achieving predefined antibody threshold \>=0.35 mcg/mL along with the corresponding 95% CI for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) were presented. Exact 2-sided CI based on the observed proportion of participants.
Outcome measures
| Measure |
7vPnC + DTaP
n=148 Participants
Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
|
DTaP (Catch-up 7vPnC)
Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
|
|---|---|---|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 Mcg/mL 1 Month After Catch-up Dose 3
4
|
100.0 Percentage of participants
Interval 97.5 to 100.0
|
—
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 Mcg/mL 1 Month After Catch-up Dose 3
6B
|
99.3 Percentage of participants
Interval 96.3 to 100.0
|
—
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 Mcg/mL 1 Month After Catch-up Dose 3
9V
|
100.0 Percentage of participants
Interval 97.5 to 100.0
|
—
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 Mcg/mL 1 Month After Catch-up Dose 3
14
|
100.0 Percentage of participants
Interval 97.5 to 100.0
|
—
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 Mcg/mL 1 Month After Catch-up Dose 3
18C
|
99.3 Percentage of participants
Interval 96.3 to 100.0
|
—
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 Mcg/mL 1 Month After Catch-up Dose 3
19F
|
100.0 Percentage of participants
Interval 97.5 to 100.0
|
—
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 Mcg/mL 1 Month After Catch-up Dose 3
23F
|
99.3 Percentage of participants
Interval 96.3 to 100.0
|
—
|
SECONDARY outcome
Timeframe: 1 month after the catch-up dose 3Population: Catch-up immunogenicity population: eligible participants who received the vaccine to which they were randomized at all 3 catch-up doses, had blood drawn within the protocol-specified time frames, had at least 1 valid, determinate assay result for proposed analysis, received no prohibited vaccines, and had no major protocol violations.
Antibody GMCs for 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) were presented. GMC and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for the specified blood draw.
Outcome measures
| Measure |
7vPnC + DTaP
n=148 Participants
Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
|
DTaP (Catch-up 7vPnC)
Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
|
|---|---|---|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Catch-up Dose 3
4
|
6.63 mcg/mL
Interval 5.91 to 7.44
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Catch-up Dose 3
6B
|
4.30 mcg/mL
Interval 3.75 to 4.93
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Catch-up Dose 3
9V
|
3.48 mcg/mL
Interval 3.12 to 3.89
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Catch-up Dose 3
14
|
11.55 mcg/mL
Interval 10.3 to 12.95
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Catch-up Dose 3
18C
|
3.10 mcg/mL
Interval 2.69 to 3.57
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Catch-up Dose 3
19F
|
5.16 mcg/mL
Interval 4.45 to 5.99
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Catch-up Dose 3
23F
|
4.41 mcg/mL
Interval 3.78 to 5.14
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Within 7 days after Dose 1 of the infant seriesPopulation: Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction. 'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters \[cm\]); Moderate (2.5 to 7.0 cm); Severe (\> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was 7vPnC injection site in the 7vPnC+DTaP group, and DTaP injection site in the DTaP (Catch-up 7vPnC) group.
Outcome measures
| Measure |
7vPnC + DTaP
n=152 Participants
Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
|
DTaP (Catch-up 7vPnC)
n=154 Participants
Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
|
|---|---|---|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 1 (3 to 6 Months of Age)
Erythema-Any (n= 152, 152)
|
57.2 Percentage of participants
|
14.5 Percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 1 (3 to 6 Months of Age)
Erythema-Mild (n= 152, 151)
|
52.6 Percentage of participants
|
12.6 Percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 1 (3 to 6 Months of Age)
Erythema-Moderate (n= 148, 152)
|
14.9 Percentage of participants
|
2.0 Percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 1 (3 to 6 Months of Age)
Erythema-Severe (n= 148, 151)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 1 (3 to 6 Months of Age)
Induration-Any (n= 149, 153)
|
40.3 Percentage of participants
|
7.8 Percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 1 (3 to 6 Months of Age)
Induration-Mild (n= 149, 153)
|
38.3 Percentage of participants
|
7.8 Percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 1 (3 to 6 Months of Age)
Induration-Moderate (n= 148, 151)
|
10.1 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 1 (3 to 6 Months of Age)
Induration-Severe (n= 148, 151)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 1 (3 to 6 Months of Age)
Tenderness-Any (n= 148, 151)
|
12.2 Percentage of participants
|
0.7 Percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 1 (3 to 6 Months of Age)
Tenderness-Significant (n= 148, 151)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 1 (3 to 6 Months of Age)
Any local reaction (n= 152, 154)
|
66.4 Percentage of participants
|
15.6 Percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Within 7 days after Dose 2 of the infant seriesPopulation: Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction. 'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters \[cm\]); Moderate (2.5 to 7.0 cm); Severe (\> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was 7vPnC injection site in the 7vPnC+DTaP group, and DTaP injection site in the DTaP (Catch-up 7vPnC) group.
Outcome measures
| Measure |
7vPnC + DTaP
n=143 Participants
Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
|
DTaP (Catch-up 7vPnC)
n=151 Participants
Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
|
|---|---|---|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 2 (4 to 8 Months of Age)
Erythema-Any (n= 142, 150)
|
64.1 Percentage of participants
|
39.3 Percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 2 (4 to 8 Months of Age)
Erythema-Mild (n= 142, 150)
|
58.5 Percentage of participants
|
33.3 Percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 2 (4 to 8 Months of Age)
Erythema-Moderate (n= 134, 147)
|
32.1 Percentage of participants
|
6.8 Percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 2 (4 to 8 Months of Age)
Erythema-Severe (n= 133, 147)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 2 (4 to 8 Months of Age)
Induration-Any (n= 137, 150)
|
51.8 Percentage of participants
|
30.0 Percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 2 (4 to 8 Months of Age)
Induration-Mild (n= 137, 150)
|
49.6 Percentage of participants
|
28.7 Percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 2 (4 to 8 Months of Age)
Induration-Moderate (n= 134, 148)
|
23.9 Percentage of participants
|
6.8 Percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 2 (4 to 8 Months of Age)
Induration-Severe (n= 133, 147)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 2 (4 to 8 Months of Age)
Tenderness-Any (n= 133, 147)
|
7.5 Percentage of participants
|
4.1 Percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 2 (4 to 8 Months of Age)
Tenderness-Significant (n= 133, 147)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 2 (4 to 8 Months of Age)
Any local reaction (n= 143, 151)
|
69.2 Percentage of participants
|
45.0 Percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Within 7 days after Dose 3 of the infant seriesPopulation: Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction. 'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters \[cm\]); Moderate (2.5 to 7.0 cm); Severe (\> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was 7vPnC injection site in the 7vPnC+DTaP group, and DTaP injection site in the DTaP (Catch-up 7vPnC) group.
Outcome measures
| Measure |
7vPnC + DTaP
n=126 Participants
Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
|
DTaP (Catch-up 7vPnC)
n=145 Participants
Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
|
|---|---|---|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 3 (5 to 10 Months of Age)
Erythema-Any (n= 123, 144)
|
52.8 Percentage of participants
|
30.6 Percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 3 (5 to 10 Months of Age)
Erythema-Mild (n= 123, 143)
|
46.3 Percentage of participants
|
28.0 Percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 3 (5 to 10 Months of Age)
Erythema-Moderate (n= 120, 139)
|
20.0 Percentage of participants
|
5.8 Percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 3 (5 to 10 Months of Age)
Erythema-Severe (n= 118, 138)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 3 (5 to 10 Months of Age)
Induration-Any (n= 124, 144)
|
44.4 Percentage of participants
|
19.4 Percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 3 (5 to 10 Months of Age)
Induration-Mild (n= 124, 144)
|
42.7 Percentage of participants
|
19.4 Percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 3 (5 to 10 Months of Age)
Induration-Moderate (n= 119, 139)
|
11.8 Percentage of participants
|
2.2 Percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 3 (5 to 10 Months of Age)
Induration-Severe (n= 118, 138)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 3 (5 to 10 Months of Age)
Tenderness-Any (n= 119, 138)
|
5.0 Percentage of participants
|
3.6 Percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 3 (5 to 10 Months of Age)
Tenderness-Significant (n= 118, 138)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 3 (5 to 10 Months of Age)
Any local reaction (n= 126, 145)
|
61.1 Percentage of participants
|
33.1 Percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Within 7 days after the toddler dosePopulation: Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction. 'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters \[cm\]); Moderate (2.5 to 7.0 cm); Severe (\> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was 7vPnC injection site in the 7vPnC+DTaP group, and DTaP injection site in the DTaP (Catch-up 7vPnC) group.
Outcome measures
| Measure |
7vPnC + DTaP
n=110 Participants
Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
|
DTaP (Catch-up 7vPnC)
n=138 Participants
Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
|
|---|---|---|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Toddler Dose (12 to 15 Months of Age)
Erythema-Any (n= 108, 137)
|
51.9 Percentage of participants
|
32.1 Percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Toddler Dose (12 to 15 Months of Age)
Erythema-Mild (n= 106, 137)
|
48.1 Percentage of participants
|
28.5 Percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Toddler Dose (12 to 15 Months of Age)
Erythema-Moderate (n= 102, 134)
|
23.5 Percentage of participants
|
7.5 Percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Toddler Dose (12 to 15 Months of Age)
Erythema-Severe (n= 98, 133)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Toddler Dose (12 to 15 Months of Age)
Induration-Any (n= 108, 137)
|
42.6 Percentage of participants
|
23.4 Percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Toddler Dose (12 to 15 Months of Age)
Induration-Mild (n= 108, 137)
|
40.7 Percentage of participants
|
19.7 Percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Toddler Dose (12 to 15 Months of Age)
Induration-Moderate (n= 99, 133)
|
16.2 Percentage of participants
|
6.8 Percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Toddler Dose (12 to 15 Months of Age)
Induration-Severe (n= 98, 133)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Toddler Dose (12 to 15 Months of Age)
Tenderness-Any (n= 99, 136)
|
11.1 Percentage of participants
|
4.4 Percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Toddler Dose (12 to 15 Months of Age)
Tenderness-Significant (n= 98, 133)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Toddler Dose (12 to 15 Months of Age)
Any local reaction (n= 110, 138)
|
56.4 Percentage of participants
|
39.1 Percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Within 7 days after Catch-up Dose 1Population: Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction. 'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction.
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters \[cm\]); Moderate (2.5 to 7.0 cm); Severe (\> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was catch-up 7vPnC injection site in the DTaP (Catch-up 7vPnC) group.
Outcome measures
| Measure |
7vPnC + DTaP
n=141 Participants
Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
|
DTaP (Catch-up 7vPnC)
Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
|
|---|---|---|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 1 (6 to 11.5 Months of Age)
Erythema-Any (n= 139)
|
51.8 Percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 1 (6 to 11.5 Months of Age)
Erythema-Mild (n= 139)
|
45.3 Percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 1 (6 to 11.5 Months of Age)
Erythema-Moderate (n= 136)
|
10.3 Percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 1 (6 to 11.5 Months of Age)
Erythema-Severe (n= 135)
|
0.0 Percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 1 (6 to 11.5 Months of Age)
Induration-Any (n= 138)
|
34.8 Percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 1 (6 to 11.5 Months of Age)
Induration-Mild (n= 138)
|
32.6 Percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 1 (6 to 11.5 Months of Age)
Induration-Moderate (n= 135)
|
8.1 Percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 1 (6 to 11.5 Months of Age)
Induration-Severe (n= 135)
|
0.0 Percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 1 (6 to 11.5 Months of Age)
Tenderness-Any (n= 136)
|
8.1 Percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 1 (6 to 11.5 Months of Age)
Tenderness-Significant (n= 135)
|
0.0 Percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 1 (6 to 11.5 Months of Age)
Any local reaction (n= 141)
|
54.6 Percentage of participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Within 7 days after Catch-up Dose 2Population: Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction. 'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction.
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters \[cm\]); Moderate (2.5 to 7.0 cm); Severe (\> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was catch-up 7vPnC injection site in the DTaP (Catch-up 7vPnC) group.
Outcome measures
| Measure |
7vPnC + DTaP
n=145 Participants
Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
|
DTaP (Catch-up 7vPnC)
Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
|
|---|---|---|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 2 (7 to 13 Months of Age)
Erythema-Any (n= 144)
|
50.7 Percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 2 (7 to 13 Months of Age)
Erythema-Mild (n= 144)
|
45.1 Percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 2 (7 to 13 Months of Age)
Erythema-Moderate (n= 140)
|
13.6 Percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 2 (7 to 13 Months of Age)
Erythema-Severe (n= 138)
|
0.0 Percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 2 (7 to 13 Months of Age)
Induration-Any (n= 144)
|
32.6 Percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 2 (7 to 13 Months of Age)
Induration-Mild (n= 143)
|
30.1 Percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 2 (7 to 13 Months of Age)
Induration-Moderate (n= 140)
|
15.0 Percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 2 (7 to 13 Months of Age)
Induration-Severe (n= 138)
|
0.0 Percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 2 (7 to 13 Months of Age)
Tenderness-Any (n= 139)
|
5.0 Percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 2 (7 to 13 Months of Age)
Tenderness-Significant (n= 138)
|
0.0 Percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 2 (7 to 13 Months of Age)
Any local reaction (n= 145)
|
55.2 Percentage of participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Within 7 days after Catch-up Dose 3Population: Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction. 'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction.
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters \[cm\]); Moderate (2.5 to 7.0 cm); Severe (\> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was catch-up 7vPnC injection site in the DTaP (Catch-up 7vPnC) group.
Outcome measures
| Measure |
7vPnC + DTaP
n=137 Participants
Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
|
DTaP (Catch-up 7vPnC)
Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
|
|---|---|---|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 3 (13 to16.5 Months of Age)
Erythema-Any (n= 134)
|
32.1 Percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 3 (13 to16.5 Months of Age)
Erythema-Mild (n= 133)
|
27.1 Percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 3 (13 to16.5 Months of Age)
Erythema-Moderate (n= 131)
|
9.9 Percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 3 (13 to16.5 Months of Age)
Erythema-Severe (n= 130)
|
0.0 Percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 3 (13 to16.5 Months of Age)
Induration-Any (n= 134)
|
27.6 Percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 3 (13 to16.5 Months of Age)
Induration-Mild (n= 133)
|
24.8 Percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 3 (13 to16.5 Months of Age)
Induration-Moderate (n= 131)
|
9.9 Percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 3 (13 to16.5 Months of Age)
Induration-Severe (n= 130)
|
0.0 Percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 3 (13 to16.5 Months of Age)
Tenderness-Any (n= 132)
|
6.8 Percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 3 (13 to16.5 Months of Age)
Tenderness-Significant (n= 130)
|
0.0 Percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 3 (13 to16.5 Months of Age)
Any local reaction (n= 137)
|
40.9 Percentage of participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Within 7 days after Dose 1 of the infant seriesPopulation: Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any systemic event. 'n'=participants reporting yes for at least 1 day or no for all days for specified systemic reaction for each group, respectively.
Systemic events (any fever \>= 37.5 degrees Celsius \[C\], decreased appetite, irritability, increased sleep, decreased sleep, and hives \[urticaria\]), were reported using an electronic diary. Participants may be represented in more than 1 category.
Outcome measures
| Measure |
7vPnC + DTaP
n=154 Participants
Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
|
DTaP (Catch-up 7vPnC)
n=153 Participants
Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
|
|---|---|---|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (3 to 6 Months of Age)
Fever >39 but =<40.0 degrees C(n=148,151)
|
2.0 Percentage of participants
|
2.0 Percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (3 to 6 Months of Age)
Fever >=37.5 but =<39 degrees C(n=149,152)
|
18.8 Percentage of participants
|
15.8 Percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (3 to 6 Months of Age)
Fever >40 degrees C(n=148,151)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (3 to 6 Months of Age)
Decreased appetite(n=148,151)
|
8.8 Percentage of participants
|
7.9 Percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (3 to 6 Months of Age)
Irritability(n=151,151)
|
15.2 Percentage of participants
|
9.3 Percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (3 to 6 Months of Age)
Increased sleep(n=150,153)
|
32.0 Percentage of participants
|
25.5 Percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (3 to 6 Months of Age)
Decreased sleep(n=151,151)
|
16.6 Percentage of participants
|
15.2 Percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (3 to 6 Months of Age)
Hives (urticaria)(n=148,151)
|
1.4 Percentage of participants
|
0.7 Percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (3 to 6 Months of Age)
Antipyretic medication to treat symptom(n=148,151)
|
1.4 Percentage of participants
|
1.3 Percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (3 to 6 Months of Age)
Any systemic event(n=154,153)
|
57.8 Percentage of participants
|
48.4 Percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Within 7 days after Dose 2 of the infant seriesPopulation: Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any systemic event. 'n'=participants reporting yes for at least 1 day or no for all days for specified systemic reaction for each group, respectively.
Systemic events (any fever \>= 37.5 degrees Celsius \[C\], decreased appetite, irritability, increased sleep, decreased sleep, and hives \[urticaria\]), were reported using an electronic diary. Participants may be represented in more than 1 category.
Outcome measures
| Measure |
7vPnC + DTaP
n=142 Participants
Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
|
DTaP (Catch-up 7vPnC)
n=153 Participants
Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
|
|---|---|---|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 to 8 Months of Age)
Fever >40 degrees C(n=133,147)
|
0.0 Percentage of participants
|
0.7 Percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 to 8 Months of Age)
Fever >=37.5 but =<39 degrees C(n=138,149)
|
25.4 Percentage of participants
|
15.4 Percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 to 8 Months of Age)
Fever >39 but =<40.0 degrees C(n=135,147)
|
2.2 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 to 8 Months of Age)
Decreased appetite(n=135,147)
|
11.9 Percentage of participants
|
5.4 Percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 to 8 Months of Age)
Irritability(n=134,149)
|
19.4 Percentage of participants
|
12.1 Percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 to 8 Months of Age)
Increased sleep(n=136,148)
|
19.1 Percentage of participants
|
12.8 Percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 to 8 Months of Age)
Decreased sleep(n=140,151)
|
17.1 Percentage of participants
|
15.2 Percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 to 8 Months of Age)
Hives (urticaria)(n=133,147)
|
3.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 to 8 Months of Age)
Antipyretic medication to treat symptom(n=134,147)
|
2.2 Percentage of participants
|
2.0 Percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 to 8 Months of Age)
Any systemic event(n=142,153)
|
53.5 Percentage of participants
|
38.6 Percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Within 7 days after Dose 3 of the infant seriesPopulation: Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any systemic event. 'n'=participants reporting yes for at least 1 day or no for all days for specified systemic reaction for each group, respectively.
Systemic events (any fever \>= 37.5 degrees Celsius \[C\], decreased appetite, irritability, increased sleep, decreased sleep, and hives \[urticaria\]), were reported using an electronic diary. Participants may be represented in more than 1 category.
Outcome measures
| Measure |
7vPnC + DTaP
n=122 Participants
Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
|
DTaP (Catch-up 7vPnC)
n=143 Participants
Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
|
|---|---|---|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (5 to 10 Months of Age)
Fever >=37.5 but =<39 degrees C(n=120,141)
|
19.2 Percentage of participants
|
14.9 Percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (5 to 10 Months of Age)
Fever >39 but =<40.0 degrees C(n=118,138)
|
1.7 Percentage of participants
|
0.7 Percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (5 to 10 Months of Age)
Fever >40 degrees C(n=118,138)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (5 to 10 Months of Age)
Decreased appetite(n=119,138)
|
8.4 Percentage of participants
|
6.5 Percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (5 to 10 Months of Age)
Irritability(n=118,139)
|
10.2 Percentage of participants
|
7.2 Percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (5 to 10 Months of Age)
Increased sleep(n=119,141)
|
16.0 Percentage of participants
|
18.4 Percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (5 to 10 Months of Age)
Decreased sleep(n=120,140)
|
6.7 Percentage of participants
|
14.3 Percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (5 to 10 Months of Age)
Hives (urticaria)(n=119,138)
|
1.7 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (5 to 10 Months of Age)
Antipyretic medication to treat symptom(n=119,138)
|
1.7 Percentage of participants
|
2.2 Percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (5 to 10 Months of Age)
Any systemic event(n=122,143)
|
39.3 Percentage of participants
|
36.4 Percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Within 7 days after the toddler dosePopulation: Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any systemic event. 'n'=participants reporting yes for at least 1 day or no for all days for specified systemic reaction for each group, respectively.
Systemic events (any fever \>= 37.5 degrees Celsius \[C\], decreased appetite, irritability, increased sleep, decreased sleep, and hives \[urticaria\]), were reported using an electronic diary. Participants may be represented in more than 1 category.
Outcome measures
| Measure |
7vPnC + DTaP
n=108 Participants
Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
|
DTaP (Catch-up 7vPnC)
n=138 Participants
Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
|
|---|---|---|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 to 15 Months of Age)
Fever >=37.5 but =<39 degrees C(n=103,135)
|
34.0 Percentage of participants
|
22.2 Percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 to 15 Months of Age)
Fever >39 but =<40.0 degrees C(n=99,132)
|
5.1 Percentage of participants
|
2.3 Percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 to 15 Months of Age)
Fever >40 degrees C(n=98,132)
|
1.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 to 15 Months of Age)
Decreased appetite(n=100,133)
|
9.0 Percentage of participants
|
8.3 Percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 to 15 Months of Age)
Irritability(n=100,134)
|
17.0 Percentage of participants
|
9.7 Percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 to 15 Months of Age)
Increased sleep(n=103,135)
|
20.4 Percentage of participants
|
15.6 Percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 to 15 Months of Age)
Decreased sleep(n=101,133)
|
10.9 Percentage of participants
|
7.5 Percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 to 15 Months of Age)
Hives (urticaria)(n=98,133)
|
1.0 Percentage of participants
|
0.8 Percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 to 15 Months of Age)
Antipyretic medication to treat symptom(n=98,133)
|
4.1 Percentage of participants
|
4.5 Percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 to 15 Months of Age)
Any systemic event(n=108,138)
|
52.8 Percentage of participants
|
39.9 Percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Within 7 days after Catch-up Dose 1Population: Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any systemic event. 'n'=participants reporting yes for at least 1 day or no for all days for specified systemic reaction.
Systemic events (any fever \>= 37.5 degrees Celsius \[C\], decreased appetite, irritability, increased sleep, decreased sleep, and hives \[urticaria\]), were reported using an electronic diary. Participants may be represented in more than 1 category.
Outcome measures
| Measure |
7vPnC + DTaP
n=139 Participants
Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
|
DTaP (Catch-up 7vPnC)
Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
|
|---|---|---|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 1 (6 to 11.5 Months of Age)
Fever >=37.5 but =<39 degrees C(n=139)
|
32.4 Percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 1 (6 to 11.5 Months of Age)
Fever >39 but =<40.0 degrees C(n=135)
|
2.2 Percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 1 (6 to 11.5 Months of Age)
Fever >40 degrees C(n=135)
|
0.0 Percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 1 (6 to 11.5 Months of Age)
Decreased appetite(n=136)
|
8.1 Percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 1 (6 to 11.5 Months of Age)
Irritability(n=136)
|
12.5 Percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 1 (6 to 11.5 Months of Age)
Increased sleep(n=136)
|
17.6 Percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 1 (6 to 11.5 Months of Age)
Decreased sleep(n=136)
|
11.8 Percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 1 (6 to 11.5 Months of Age)
Hives (urticaria)(n=135)
|
0.7 Percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 1 (6 to 11.5 Months of Age)
Antipyretic medication to treat symptom(n=136)
|
5.9 Percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 1 (6 to 11.5 Months of Age)
Any systemic event(n=139)
|
49.6 Percentage of participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Within 7 days after Catch-up Dose 2Population: Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any systemic event. 'n'=participants reporting yes for at least 1 day or no for all days for specified systemic reaction.
Systemic events (any fever \>= 37.5 degrees Celsius \[C\], decreased appetite, irritability, increased sleep, decreased sleep, and hives \[urticaria\]), were reported using an electronic diary. Participants may be represented in more than 1 category.
Outcome measures
| Measure |
7vPnC + DTaP
n=141 Participants
Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
|
DTaP (Catch-up 7vPnC)
Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
|
|---|---|---|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 2 (7 to 13 Months of Age)
Increased sleep(n=138)
|
15.9 Percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 2 (7 to 13 Months of Age)
Decreased sleep(n=139)
|
10.1 Percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 2 (7 to 13 Months of Age)
Hives (urticaria)(n=138)
|
2.2 Percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 2 (7 to 13 Months of Age)
Antipyretic medication to treat symptom(n=138)
|
5.1 Percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 2 (7 to 13 Months of Age)
Any systemic event(n=141)
|
47.5 Percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 2 (7 to 13 Months of Age)
Fever >=37.5 but =<39 degrees C(n=140)
|
32.1 Percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 2 (7 to 13 Months of Age)
Fever >39 but =<40.0 degrees C(n=138)
|
5.1 Percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 2 (7 to 13 Months of Age)
Fever >40 degrees C(n=138)
|
0.7 Percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 2 (7 to 13 Months of Age)
Decreased appetite(n=138)
|
10.9 Percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 2 (7 to 13 Months of Age)
Irritability(n=138)
|
11.6 Percentage of participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Within 7 days after Catch-up Dose 3Population: Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any systemic event. 'n'=participants reporting yes for at least 1 day or no for all days for specified systemic reaction.
Systemic events (any fever \>= 37.5 degrees Celsius \[C\], decreased appetite, irritability, increased sleep, decreased sleep, and hives \[urticaria\]), were reported using an electronic diary. Participants may be represented in more than 1 category.
Outcome measures
| Measure |
7vPnC + DTaP
n=136 Participants
Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
|
DTaP (Catch-up 7vPnC)
Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
|
|---|---|---|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 3 (13 to 16.5 Months of Age)
Fever >=37.5 but =<39 degrees C(n=134)
|
26.9 Percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 3 (13 to 16.5 Months of Age)
Fever >39 but =<40.0 degrees C(n=130)
|
0.8 Percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 3 (13 to 16.5 Months of Age)
Fever >40 degrees C(n=130)
|
0.0 Percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 3 (13 to 16.5 Months of Age)
Decreased appetite(n=130)
|
6.2 Percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 3 (13 to 16.5 Months of Age)
Irritability(n=131)
|
9.2 Percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 3 (13 to 16.5 Months of Age)
Increased sleep(n=131)
|
10.7 Percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 3 (13 to 16.5 Months of Age)
Decreased sleep(n=131)
|
6.9 Percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 3 (13 to 16.5 Months of Age)
Hives (urticaria)(n=131)
|
0.8 Percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 3 (13 to 16.5 Months of Age)
Antipyretic medication to treat symptom(n=130)
|
1.5 Percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 3 (13 to 16.5 Months of Age)
Any systemic event(n=136)
|
39.0 Percentage of participants
|
—
|
Adverse Events
7vPnC + DTaP - Infant Series
Serious events: 3 serious events
Other events: 123 other events
Deaths: 0 deaths
DTaP (Catch-up 7vPnC)- Infant Series
Serious events: 7 serious events
Other events: 126 other events
Deaths: 0 deaths
7vPnC + DTaP - After the Infant Series
Serious events: 10 serious events
Other events: 20 other events
Deaths: 0 deaths
DTaP (Catch-up 7vPnC) - After the Infant Series
Serious events: 7 serious events
Other events: 129 other events
Deaths: 0 deaths
7vPnC + DTaP - Toddler Dose
Serious events: 0 serious events
Other events: 72 other events
Deaths: 0 deaths
DTaP (Catch-up 7vPnC) - Toddler Dose
Serious events: 4 serious events
Other events: 96 other events
Deaths: 0 deaths
DTaP (Catch-up 7vPnC) - After the Toddler Dose
Serious events: 1 serious events
Other events: 85 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
7vPnC + DTaP - Infant Series
n=159 participants at risk
Participants who received 3 single 0.5 mL doses of 7vPnC subcutaneously 4 to 8 weeks apart along with 3 single 0.5 mL doses of DTaP subcutaneously (infant series), assessed from Infant Dose 1 through the blood draw 28 to 42 days post-infant series.
|
DTaP (Catch-up 7vPnC)- Infant Series
n=158 participants at risk
Participants who received 3 single 0.5 mL DTaP doses subcutaneously 4 to 8 weeks apart (infant series) followed by 2 single catch-up (CU) doses, CU Dose 1 and CU Dose 2 (separated by 4 to 6 weeks), of 7vPnC (Prevenar) 4 to 6 weeks post-infant series, assessed from Infant Dose 1 through the CU Dose 1.
|
7vPnC + DTaP - After the Infant Series
n=159 participants at risk
Participants who received 3 single 0.5 mL doses of 7vPnC subcutaneously 4 to 8 weeks apart along with 3 single 0.5 mL doses of DTaP subcutaneously (infant series), assessed after the infant series blood draw to the toddler dose.
|
DTaP (Catch-up 7vPnC) - After the Infant Series
n=158 participants at risk
Participants who received 3 single 0.5 mL DTaP doses subcutaneously 4 to 8 weeks apart (infant series) followed by 2 single catch-up (CU) doses, CU Dose 1 and CU Dose 2 (separated by 4 to 6 weeks), of 7vPnC (Prevenar) 4 to 6 weeks post-infant series, assessed after CU Dose 1 to the toddler dose.
|
7vPnC + DTaP - Toddler Dose
n=122 participants at risk
Participants who received a single 0.5 mL dose of 7vPnC subcutaneously (toddler dose) along with 0.5 mL dose of DTaP subcutaneously, assessed from the toddler dose through the blood draw 28 to 42 days post-toddler dose.
|
DTaP (Catch-up 7vPnC) - Toddler Dose
n=149 participants at risk
Participants who received a single 0.5 mL DTaP dose subcutaneously (toddler dose) followed by a single catch-up (CU) dose (CU Dose 3) of 7vPnC (Prevenar) 4 to 6 weeks after toddler dose; assessed from toddler dose through the CU Dose 3.
|
DTaP (Catch-up 7vPnC) - After the Toddler Dose
n=149 participants at risk
Participants who received a single 0.5 mL DTaP dose subcutaneously (toddler dose) followed by a single catch-up (CU) dose (CU Dose 3) of 7vPnC (Prevenar) 4 to 6 weeks after toddler dose; assessed after the CU Dose 3 to 28 to 42 days post-CU Dose 3.
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.63%
1/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Gastrointestinal disorders
Intussusception
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.63%
1/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.63%
1/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.63%
1/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
General disorders
Pyrexia
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.63%
1/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Gastroenteritis viral
|
0.63%
1/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.63%
1/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.63%
1/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Respiratory syncytial virus bronchitis
|
0.63%
1/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.63%
1/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Bronchitis bacterial
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.63%
1/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Respiratory syncytial virus bronchiolitis
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.63%
1/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Metabolism and nutrition disorders
Weight gain poor
|
0.63%
1/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Respiratory, thoracic and mediastinal disorders
Adenoidal hypertrophy
|
0.63%
1/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
0.63%
1/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar hypertrophy
|
0.63%
1/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Congenital, familial and genetic disorders
Cryptorchism
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.63%
1/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Bronchitis
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.63%
1/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.63%
1/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
1.3%
2/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Adenovirus infection
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.63%
1/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Exanthema subitum
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.63%
1/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Gastroenteritis adenovirus
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.63%
1/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Otitis media
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.63%
1/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Pneumonia mycoplasmal
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.63%
1/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Pneumonia respiratory syncytial viral
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.63%
1/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.63%
1/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Nervous system disorders
Febrile convulsion
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
2.5%
4/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
1.3%
2/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.67%
1/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.67%
1/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Respiratory, thoracic and mediastinal disorders
Infantile asthma
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.63%
1/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.63%
1/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Vascular disorders
Kawasaki's disease
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.63%
1/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
1.3%
2/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.67%
1/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
Other adverse events
| Measure |
7vPnC + DTaP - Infant Series
n=159 participants at risk
Participants who received 3 single 0.5 mL doses of 7vPnC subcutaneously 4 to 8 weeks apart along with 3 single 0.5 mL doses of DTaP subcutaneously (infant series), assessed from Infant Dose 1 through the blood draw 28 to 42 days post-infant series.
|
DTaP (Catch-up 7vPnC)- Infant Series
n=158 participants at risk
Participants who received 3 single 0.5 mL DTaP doses subcutaneously 4 to 8 weeks apart (infant series) followed by 2 single catch-up (CU) doses, CU Dose 1 and CU Dose 2 (separated by 4 to 6 weeks), of 7vPnC (Prevenar) 4 to 6 weeks post-infant series, assessed from Infant Dose 1 through the CU Dose 1.
|
7vPnC + DTaP - After the Infant Series
n=159 participants at risk
Participants who received 3 single 0.5 mL doses of 7vPnC subcutaneously 4 to 8 weeks apart along with 3 single 0.5 mL doses of DTaP subcutaneously (infant series), assessed after the infant series blood draw to the toddler dose.
|
DTaP (Catch-up 7vPnC) - After the Infant Series
n=158 participants at risk
Participants who received 3 single 0.5 mL DTaP doses subcutaneously 4 to 8 weeks apart (infant series) followed by 2 single catch-up (CU) doses, CU Dose 1 and CU Dose 2 (separated by 4 to 6 weeks), of 7vPnC (Prevenar) 4 to 6 weeks post-infant series, assessed after CU Dose 1 to the toddler dose.
|
7vPnC + DTaP - Toddler Dose
n=122 participants at risk
Participants who received a single 0.5 mL dose of 7vPnC subcutaneously (toddler dose) along with 0.5 mL dose of DTaP subcutaneously, assessed from the toddler dose through the blood draw 28 to 42 days post-toddler dose.
|
DTaP (Catch-up 7vPnC) - Toddler Dose
n=149 participants at risk
Participants who received a single 0.5 mL DTaP dose subcutaneously (toddler dose) followed by a single catch-up (CU) dose (CU Dose 3) of 7vPnC (Prevenar) 4 to 6 weeks after toddler dose; assessed from toddler dose through the CU Dose 3.
|
DTaP (Catch-up 7vPnC) - After the Toddler Dose
n=149 participants at risk
Participants who received a single 0.5 mL DTaP dose subcutaneously (toddler dose) followed by a single catch-up (CU) dose (CU Dose 3) of 7vPnC (Prevenar) 4 to 6 weeks after toddler dose; assessed after the CU Dose 3 to 28 to 42 days post-CU Dose 3.
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.63%
1/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.63%
1/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
1.3%
2/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
1.3%
2/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.67%
1/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Eye disorders
Conjunctivitis
|
3.8%
6/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
8.9%
14/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
5.7%
9/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.82%
1/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
2.7%
4/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
1.3%
2/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Eye disorders
Eye discharge
|
1.9%
3/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
1.9%
3/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
1.3%
2/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.82%
1/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
1.3%
2/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Eye disorders
Keratitis
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.63%
1/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.63%
1/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.63%
1/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Gastrointestinal disorders
Constipation
|
5.0%
8/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
5.1%
8/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
3.8%
6/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.82%
1/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.67%
1/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Gastrointestinal disorders
Diarrhoea
|
4.4%
7/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
5.7%
9/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.63%
1/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
5.1%
8/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
4.9%
6/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
4.0%
6/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
1.3%
2/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Gastrointestinal disorders
Haematochezia
|
0.63%
1/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.63%
1/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.63%
1/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Gastrointestinal disorders
Dyspepsia
|
0.63%
1/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Gastrointestinal disorders
Ileus
|
0.63%
1/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.63%
1/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Gastrointestinal disorders
Intussusception
|
0.63%
1/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.63%
1/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Gastrointestinal disorders
Vomiting
|
0.63%
1/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
1.3%
2/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.82%
1/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
General disorders
Vaccination site erythema
|
3.1%
5/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
6.3%
10/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
1.3%
2/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
General disorders
Pyrexia
|
3.1%
5/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
2.5%
4/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.67%
1/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
General disorders
Vaccination site induration
|
0.63%
1/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
2.5%
4/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
1.3%
2/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
General disorders
Injection site induration
|
0.63%
1/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.63%
1/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
General disorders
Vaccination site swelling
|
0.63%
1/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.63%
1/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
General disorders
Application site erythema
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.63%
1/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
General disorders
Injection site haemorrhage
|
0.63%
1/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Immune system disorders
Food allergy
|
1.3%
2/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.63%
1/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
3.8%
6/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
3.8%
6/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.82%
1/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Immune system disorders
Allergy to arthropod bite
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.63%
1/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Immune system disorders
Milk allergy
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.63%
1/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.63%
1/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.63%
1/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Nasopharyngitis
|
30.8%
49/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
37.3%
59/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.63%
1/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
39.9%
63/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
22.1%
27/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
28.9%
43/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
28.2%
42/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Upper respiratory tract infection
|
22.0%
35/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
13.9%
22/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
3.1%
5/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
17.1%
27/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
13.9%
17/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
12.8%
19/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
6.7%
10/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Gastroenteritis
|
11.9%
19/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
7.6%
12/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
8.2%
13/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
1.6%
2/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
2.7%
4/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
5.4%
8/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Influenza
|
10.1%
16/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
7.6%
12/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.67%
1/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.67%
1/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Bronchitis
|
6.3%
10/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
7.0%
11/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
10.8%
17/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
9.0%
11/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
8.1%
12/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
6.0%
9/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Exanthema subitum
|
3.8%
6/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
8.2%
13/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
13.3%
21/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
1.6%
2/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
4.7%
7/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
2.7%
4/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Gastroenteritis viral
|
4.4%
7/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
1.9%
3/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
1.3%
2/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.67%
1/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Varicella
|
3.1%
5/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
1.9%
3/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
1.3%
2/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
1.6%
2/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
2.0%
3/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
1.3%
2/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Impetigo
|
1.3%
2/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
3.2%
5/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
1.3%
2/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.67%
1/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.67%
1/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Otitis media
|
3.1%
5/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
1.3%
2/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
5.7%
9/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
3.3%
4/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
1.3%
2/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
1.3%
2/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Respiratory syncytial virus infection
|
1.3%
2/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
3.2%
5/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
1.6%
2/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Bronchiolitis
|
3.1%
5/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.63%
1/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.67%
1/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Pharyngitis
|
0.63%
1/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
3.2%
5/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
2.7%
4/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
3.2%
5/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
2.5%
4/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.67%
1/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Enteritis infectious
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
1.9%
3/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.63%
1/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.82%
1/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Rhinitis
|
0.63%
1/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
1.3%
2/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
2.0%
3/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.67%
1/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Gastroenteritis rotavirus
|
1.3%
2/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Molluscum contagiosum
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
1.3%
2/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
1.3%
2/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Oral candidiasis
|
0.63%
1/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.63%
1/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.63%
1/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Otitis externa
|
1.3%
2/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Paronychia
|
1.3%
2/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.63%
1/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Respiratory syncytial virus bronchitis
|
0.63%
1/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.63%
1/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Tonsillitis
|
0.63%
1/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.63%
1/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.63%
1/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.82%
1/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.67%
1/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Adenovirus infection
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.63%
1/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.63%
1/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Cellulitis
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.63%
1/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.63%
1/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Conjunctivitis viral
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.63%
1/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Croup infectious
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.63%
1/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.67%
1/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Fungal infection
|
0.63%
1/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Fungal skin infection
|
0.63%
1/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.63%
1/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Genital candidiasis
|
0.63%
1/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
0.63%
1/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
7.0%
11/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
3.3%
4/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
4.0%
6/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
1.3%
2/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Hordeolum
|
0.63%
1/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Mucocutaneous candidiasis
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.63%
1/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Respiratory tract infection
|
0.63%
1/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Rotavirus infection
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.63%
1/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.63%
1/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.67%
1/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Sinusitis
|
0.63%
1/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.67%
1/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Staphylococcal scalded skin syndrome
|
0.63%
1/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Vaccination site infection
|
0.63%
1/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Viral infection
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.63%
1/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Viral rash
|
0.63%
1/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.63%
1/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.82%
1/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.67%
1/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
1.3%
2/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.63%
1/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.82%
1/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Injury, poisoning and procedural complications
Contusion
|
0.63%
1/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
2.0%
3/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.67%
1/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.63%
1/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.63%
1/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.82%
1/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.67%
1/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
1.3%
2/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Investigations
Alanine aminotransferase increased
|
0.63%
1/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Investigations
Aspartate aminotransferase increased
|
0.63%
1/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.63%
1/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Metabolism and nutrition disorders
Lactose intolerance
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.63%
1/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.63%
1/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.82%
1/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.63%
1/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.63%
1/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.63%
1/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
1.9%
3/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.63%
1/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.63%
1/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.63%
1/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.67%
1/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.67%
1/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Eczema
|
16.4%
26/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
13.9%
22/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
1.3%
2/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
2.5%
4/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
1.6%
2/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
2.0%
3/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
3.4%
5/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
10.1%
16/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
8.2%
13/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.63%
1/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
8.2%
13/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
5.7%
7/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
1.3%
2/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
2.7%
4/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Eczema infantile
|
3.8%
6/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
5.1%
8/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.63%
1/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.63%
1/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Asteatosis
|
3.1%
5/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
2.5%
4/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.63%
1/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.82%
1/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.67%
1/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.67%
1/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.63%
1/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
3.8%
6/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.63%
1/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
1.3%
2/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.82%
1/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.67%
1/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.67%
1/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Heat rash
|
1.9%
3/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
1.9%
3/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
10.1%
16/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
1.6%
2/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.67%
1/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.67%
1/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.63%
1/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
1.9%
3/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
2.5%
4/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
1.9%
3/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
1.3%
2/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
1.9%
3/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.82%
1/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
1.3%
2/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.63%
1/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.63%
1/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
1.9%
3/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.63%
1/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.63%
1/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.63%
1/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
1.9%
3/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
1.3%
2/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.67%
1/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.63%
1/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.63%
1/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
1.3%
2/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.67%
1/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.63%
1/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.63%
1/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
1.6%
2/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.67%
1/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
1.3%
2/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.63%
1/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.63%
1/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Cardiac disorders
Wolff-Parkinson-White syndrome
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.63%
1/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Respiratory, thoracic and mediastinal disorders
Infantile asthma
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.63%
1/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis perennial
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.63%
1/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.63%
1/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Immune system disorders
Allergy to animal
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.63%
1/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.82%
1/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.63%
1/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Gastroenteritis bacterial
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
1.3%
2/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Candidiasis
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.63%
1/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Conjunctivitis bacterial
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.63%
1/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.67%
1/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Herpangina
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.63%
1/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.82%
1/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.67%
1/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.63%
1/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Localised infection
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.63%
1/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Otitis media bacterial
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.63%
1/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
2.5%
4/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.82%
1/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.63%
1/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Generalised erythema
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.63%
1/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.67%
1/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Candida nappy rash
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.82%
1/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.67%
1/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.67%
1/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Injury, poisoning and procedural complications
Face injury
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.67%
1/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.82%
1/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Reproductive system and breast disorders
Genital rash
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.82%
1/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.67%
1/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Eye disorders
Eyelid oedema
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.67%
1/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.67%
1/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.67%
1/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Gastroenteritis adenovirus
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.67%
1/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Injury, poisoning and procedural complications
Lip injury
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.67%
1/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Eczema asteatotic
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/159 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/158 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/122 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.67%
1/149 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Erythema (Any)
|
52.8%
65/123 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
30.6%
44/144 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
32.1%
43/134 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Erythema (Mild)
|
46.3%
57/123 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
28.0%
40/143 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
27.1%
36/133 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Erythema (Moderate)
|
20.0%
24/120 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
5.8%
8/139 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
9.9%
13/131 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Erythema (Severe)
|
0.00%
0/118 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/138 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/130 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Induration (Any)
|
44.4%
55/124 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
19.4%
28/144 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
27.6%
37/134 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Induration (Mild)
|
42.7%
53/124 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
19.4%
28/144 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
24.8%
33/133 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Induration (Moderate)
|
11.8%
14/119 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
2.2%
3/139 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
9.9%
13/131 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Induration (Severe)
|
0.00%
0/118 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/138 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/130 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Tenderness (Any)
|
5.0%
6/119 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
3.6%
5/138 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
6.8%
9/132 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Tenderness (Significant)
|
0.00%
0/118 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/138 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/130 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
General disorders
Fever ≥37.5°C but ≤39°C
|
19.2%
23/120 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
14.9%
21/141 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
General disorders
Fever>39°C but ≤40°C
|
1.7%
2/118 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.72%
1/138 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
General disorders
Fever >40.0°C
|
0.00%
0/118 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/138 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
General disorders
Decreased appetite
|
8.4%
10/119 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
6.5%
9/138 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
General disorders
Irritability
|
10.2%
12/118 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
7.2%
10/139 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
General disorders
Increased sleep
|
16.0%
19/119 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
18.4%
26/141 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
General disorders
Decreased sleep
|
6.7%
8/120 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
14.3%
20/140 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
General disorders
Hives (urticaria)
|
1.7%
2/119 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/138 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
|
General disorders
Use of antipyretic medication to treat symptoms
|
1.7%
2/119 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
2.2%
3/138 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER