Trial Outcomes & Findings for Study Assessing the Effect of Medications to Prevent Fever on Prevenar 13® (NCT NCT01392378)
NCT ID: NCT01392378
Last Updated: 2014-02-26
Results Overview
Antibody geometric least squares (LS) mean concentrations (GMCs) for 13 pneumococcal serotypes (4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95 percent (%) confidence interval (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies participants with a determinate IgG concentration to the given serotype for each arm, respectively.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
908 participants
Primary outcome timeframe
1 month after the infant series
Results posted on
2014-02-26
Participant Flow
Participant milestones
| Measure |
13vPnC + INFANRIX Hexa + Paracetamol Twice Daily
Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (greater than or equal to \[\>=\]56 to less than or equal to \[\<=\]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
|
13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
|
13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
|
13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
|
13vPnC + INFANRIX Hexa
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
|
|---|---|---|---|---|---|
|
Infant Series
STARTED
|
173
|
176
|
172
|
177
|
210
|
|
Infant Series
Vaccinated Dose 1
|
173
|
176
|
172
|
177
|
210
|
|
Infant Series
Vaccinated Dose 2
|
171
|
174
|
172
|
177
|
210
|
|
Infant Series
Vaccinated Dose 3
|
170
|
174
|
172
|
176
|
210
|
|
Infant Series
COMPLETED
|
169
|
174
|
172
|
175
|
210
|
|
Infant Series
NOT COMPLETED
|
4
|
2
|
0
|
2
|
0
|
|
After Infant Series
STARTED
|
169
|
174
|
172
|
175
|
210
|
|
After Infant Series
COMPLETED
|
169
|
173
|
170
|
175
|
209
|
|
After Infant Series
NOT COMPLETED
|
0
|
1
|
2
|
0
|
1
|
|
Toddler Dose
STARTED
|
169
|
173
|
170
|
175
|
209
|
|
Toddler Dose
COMPLETED
|
169
|
172
|
170
|
173
|
208
|
|
Toddler Dose
NOT COMPLETED
|
0
|
1
|
0
|
2
|
1
|
Reasons for withdrawal
| Measure |
13vPnC + INFANRIX Hexa + Paracetamol Twice Daily
Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (greater than or equal to \[\>=\]56 to less than or equal to \[\<=\]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
|
13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
|
13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
|
13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
|
13vPnC + INFANRIX Hexa
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
|
|---|---|---|---|---|---|
|
Infant Series
Adverse Event
|
0
|
0
|
0
|
1
|
0
|
|
Infant Series
Lost to Follow-up
|
0
|
0
|
0
|
1
|
0
|
|
Infant Series
Protocol Violation
|
0
|
1
|
0
|
0
|
0
|
|
Infant Series
Withdrawal by Parent
|
4
|
1
|
0
|
0
|
0
|
|
After Infant Series
Lost to Follow-up
|
0
|
0
|
1
|
0
|
0
|
|
After Infant Series
Withdrawal by Parent
|
0
|
1
|
1
|
0
|
1
|
|
Toddler Dose
Lost to Follow-up
|
0
|
0
|
0
|
1
|
0
|
|
Toddler Dose
Withdrawal by Parent
|
0
|
1
|
0
|
1
|
1
|
Baseline Characteristics
Study Assessing the Effect of Medications to Prevent Fever on Prevenar 13®
Baseline characteristics by cohort
| Measure |
13vPnC + INFANRIX Hexa + Paracetamol Twice Daily
n=173 Participants
Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (greater than or equal to \[\>=\]56 to less than or equal to \[\<=\]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
|
13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily
n=176 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
|
13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily
n=172 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
|
13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily
n=177 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
|
13vPnC + INFANRIX Hexa
n=210 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
|
Total
n=908 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
65.1 days
STANDARD_DEVIATION 9.5 • n=5 Participants
|
66.5 days
STANDARD_DEVIATION 10.1 • n=7 Participants
|
65.6 days
STANDARD_DEVIATION 9.7 • n=5 Participants
|
66.4 days
STANDARD_DEVIATION 10.3 • n=4 Participants
|
65.6 days
STANDARD_DEVIATION 9.4 • n=21 Participants
|
65.8 days
STANDARD_DEVIATION 9.8 • n=10 Participants
|
|
Sex: Female, Male
Female
|
87 Participants
n=5 Participants
|
89 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
79 Participants
n=4 Participants
|
98 Participants
n=21 Participants
|
428 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
86 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
98 Participants
n=4 Participants
|
112 Participants
n=21 Participants
|
480 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: 1 month after the infant seriesPopulation: Modified intent-to-treat (mITT) infant immunogenicity set: all eligible participants who had \>=1 valid,determinate assay result, 56-98 days of age at Vaccination 1, received antipyretic regimen as per randomization,may have had received additional anti-pyretic medication,had blood drawn within specified time frames,had no major protocol violations.
Antibody geometric least squares (LS) mean concentrations (GMCs) for 13 pneumococcal serotypes (4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95 percent (%) confidence interval (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies participants with a determinate IgG concentration to the given serotype for each arm, respectively.
Outcome measures
| Measure |
13vPnC + INFANRIX Hexa + Paracetamol Twice Daily
n=138 Participants
Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (greater than or equal to \[\>=\]56 to less than or equal to \[\<=\]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
|
13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily
n=155 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
|
13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily
n=148 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
|
13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily
n=147 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
|
13vPnC + INFANRIX Hexa
n=210 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
|
|---|---|---|---|---|---|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series
23F (n= 137, 155, 148, 146, 210)
|
0.85 microgram per milliliter (mcg/mL)
Interval 0.72 to 1.0
|
1.19 microgram per milliliter (mcg/mL)
Interval 1.02 to 1.4
|
0.73 microgram per milliliter (mcg/mL)
Interval 0.62 to 0.86
|
1.07 microgram per milliliter (mcg/mL)
Interval 0.91 to 1.26
|
1.04 microgram per milliliter (mcg/mL)
Interval 0.91 to 1.19
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series
4 (n = 137, 155, 148, 146, 210)
|
1.64 microgram per milliliter (mcg/mL)
Interval 1.44 to 1.87
|
1.99 microgram per milliliter (mcg/mL)
Interval 1.76 to 2.25
|
1.48 microgram per milliliter (mcg/mL)
Interval 1.31 to 1.68
|
2.07 microgram per milliliter (mcg/mL)
Interval 1.82 to 2.34
|
2.02 microgram per milliliter (mcg/mL)
Interval 1.82 to 2.25
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series
6B (n = 136, 155, 148, 146, 210)
|
0.68 microgram per milliliter (mcg/mL)
Interval 0.55 to 0.83
|
0.91 microgram per milliliter (mcg/mL)
Interval 0.76 to 1.1
|
0.56 microgram per milliliter (mcg/mL)
Interval 0.46 to 0.68
|
0.90 microgram per milliliter (mcg/mL)
Interval 0.74 to 1.09
|
0.81 microgram per milliliter (mcg/mL)
Interval 0.69 to 0.96
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series
9V (n = 138, 155, 148, 147, 210)
|
1.13 microgram per milliliter (mcg/mL)
Interval 1.01 to 1.27
|
1.45 microgram per milliliter (mcg/mL)
Interval 1.3 to 1.61
|
1.17 microgram per milliliter (mcg/mL)
Interval 1.05 to 1.3
|
1.40 microgram per milliliter (mcg/mL)
Interval 1.26 to 1.56
|
1.31 microgram per milliliter (mcg/mL)
Interval 1.19 to 1.43
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series
14 (n = 138, 155, 148, 147, 210)
|
4.45 microgram per milliliter (mcg/mL)
Interval 3.76 to 5.26
|
4.73 microgram per milliliter (mcg/mL)
Interval 4.04 to 5.54
|
4.75 microgram per milliliter (mcg/mL)
Interval 4.04 to 5.58
|
5.26 microgram per milliliter (mcg/mL)
Interval 4.48 to 6.19
|
5.38 microgram per milliliter (mcg/mL)
Interval 4.7 to 6.16
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series
18C (n = 138, 155, 148, 147, 210)
|
1.47 microgram per milliliter (mcg/mL)
Interval 1.29 to 1.66
|
1.73 microgram per milliliter (mcg/mL)
Interval 1.54 to 1.95
|
1.25 microgram per milliliter (mcg/mL)
Interval 1.11 to 1.42
|
1.75 microgram per milliliter (mcg/mL)
Interval 1.55 to 1.97
|
1.54 microgram per milliliter (mcg/mL)
Interval 1.39 to 1.7
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series
19F (n = 138, 155, 148, 147, 210)
|
1.78 microgram per milliliter (mcg/mL)
Interval 1.57 to 2.02
|
2.30 microgram per milliliter (mcg/mL)
Interval 2.04 to 2.59
|
1.59 microgram per milliliter (mcg/mL)
Interval 1.41 to 1.8
|
2.04 microgram per milliliter (mcg/mL)
Interval 1.81 to 2.31
|
1.99 microgram per milliliter (mcg/mL)
Interval 1.8 to 2.2
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series
1 (n = 138, 155, 148, 147, 210)
|
1.12 microgram per milliliter (mcg/mL)
Interval 0.98 to 1.27
|
1.50 microgram per milliliter (mcg/mL)
Interval 1.33 to 1.69
|
1.02 microgram per milliliter (mcg/mL)
Interval 0.9 to 1.16
|
1.29 microgram per milliliter (mcg/mL)
Interval 1.14 to 1.47
|
1.25 microgram per milliliter (mcg/mL)
Interval 1.12 to 1.38
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series
3 (n = 138, 155, 148, 147, 210)
|
0.71 microgram per milliliter (mcg/mL)
Interval 0.63 to 0.79
|
0.83 microgram per milliliter (mcg/mL)
Interval 0.75 to 0.93
|
0.57 microgram per milliliter (mcg/mL)
Interval 0.51 to 0.64
|
0.84 microgram per milliliter (mcg/mL)
Interval 0.75 to 0.94
|
0.88 microgram per milliliter (mcg/mL)
Interval 0.79 to 0.96
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series
5 (n = 137, 155, 148, 146, 210)
|
0.79 microgram per milliliter (mcg/mL)
Interval 0.69 to 0.91
|
0.98 microgram per milliliter (mcg/mL)
Interval 0.86 to 1.11
|
0.63 microgram per milliliter (mcg/mL)
Interval 0.55 to 0.72
|
0.90 microgram per milliliter (mcg/mL)
Interval 0.78 to 1.02
|
0.81 microgram per milliliter (mcg/mL)
Interval 0.73 to 0.91
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series
6A (n = 138, 155, 148, 146, 210)
|
0.97 microgram per milliliter (mcg/mL)
Interval 0.84 to 1.13
|
1.25 microgram per milliliter (mcg/mL)
Interval 1.09 to 1.44
|
0.85 microgram per milliliter (mcg/mL)
Interval 0.74 to 0.98
|
1.22 microgram per milliliter (mcg/mL)
Interval 1.06 to 1.41
|
1.10 microgram per milliliter (mcg/mL)
Interval 0.97 to 1.24
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series
7F (n = 138, 155, 148, 146, 210)
|
1.94 microgram per milliliter (mcg/mL)
Interval 1.74 to 2.16
|
2.22 microgram per milliliter (mcg/mL)
Interval 2.01 to 2.46
|
1.83 microgram per milliliter (mcg/mL)
Interval 1.65 to 2.03
|
2.28 microgram per milliliter (mcg/mL)
Interval 2.06 to 2.53
|
2.15 microgram per milliliter (mcg/mL)
Interval 1.97 to 2.34
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series
19A (n = 137, 155, 148, 146, 210)
|
2.70 microgram per milliliter (mcg/mL)
Interval 2.38 to 3.07
|
3.39 microgram per milliliter (mcg/mL)
Interval 3.01 to 3.82
|
2.53 microgram per milliliter (mcg/mL)
Interval 2.24 to 2.86
|
3.14 microgram per milliliter (mcg/mL)
Interval 2.77 to 3.55
|
3.02 microgram per milliliter (mcg/mL)
Interval 2.72 to 3.34
|
SECONDARY outcome
Timeframe: 1 month after the infant seriesPopulation: mITT infant immunogenicity population. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies participants with a determinate IgG concentration to the given serotype for each arm, respectively.
Percentage of participants achieving predefined antibody threshold \>=0.35 mcg/mL along with the corresponding 95% confidence interval (CI) for 13 pneumococcal serotypes (4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.
Outcome measures
| Measure |
13vPnC + INFANRIX Hexa + Paracetamol Twice Daily
n=138 Participants
Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (greater than or equal to \[\>=\]56 to less than or equal to \[\<=\]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
|
13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily
n=155 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
|
13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily
n=148 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
|
13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily
n=147 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
|
13vPnC + INFANRIX Hexa
n=210 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
|
|---|---|---|---|---|---|
|
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 (n = 137, 155, 148, 146, 210)
|
96.4 percentage of participants
Interval 91.69 to 98.8
|
97.4 percentage of participants
Interval 93.52 to 99.29
|
96.6 percentage of participants
Interval 92.29 to 98.89
|
97.3 percentage of participants
Interval 93.13 to 99.25
|
98.1 percentage of participants
Interval 95.2 to 99.48
|
|
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 (n = 136, 155, 148, 146, 210)
|
72.8 percentage of participants
Interval 64.5 to 80.07
|
80.0 percentage of participants
Interval 72.83 to 85.99
|
61.5 percentage of participants
Interval 53.14 to 69.36
|
79.5 percentage of participants
Interval 71.98 to 85.69
|
77.6 percentage of participants
Interval 71.37 to 83.07
|
|
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 (n = 138, 155, 148, 147, 210)
|
94.2 percentage of participants
Interval 88.9 to 97.46
|
99.4 percentage of participants
Interval 96.46 to 99.98
|
95.9 percentage of participants
Interval 91.39 to 98.5
|
95.9 percentage of participants
Interval 91.33 to 98.49
|
96.2 percentage of participants
Interval 92.63 to 98.34
|
|
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 (n = 138, 155, 148, 147, 210)
|
100.0 percentage of participants
Interval 97.36 to 100.0
|
98.7 percentage of participants
Interval 95.42 to 99.84
|
99.3 percentage of participants
Interval 96.29 to 99.98
|
98.6 percentage of participants
Interval 95.17 to 99.83
|
99.5 percentage of participants
Interval 97.38 to 99.99
|
|
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 (n = 138, 155, 148, 147, 210)
|
96.4 percentage of participants
Interval 91.75 to 98.81
|
97.4 percentage of participants
Interval 93.52 to 99.29
|
95.3 percentage of participants
Interval 90.5 to 98.08
|
95.9 percentage of participants
Interval 91.33 to 98.49
|
96.7 percentage of participants
Interval 93.25 to 98.65
|
|
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 (n = 138, 155, 148, 147, 210)
|
97.1 percentage of participants
Interval 92.74 to 99.2
|
99.4 percentage of participants
Interval 96.46 to 99.98
|
95.3 percentage of participants
Interval 90.5 to 98.08
|
96.6 percentage of participants
Interval 92.24 to 98.89
|
97.6 percentage of participants
Interval 94.53 to 99.22
|
|
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 (n = 137, 155, 148, 146, 210)
|
86.1 percentage of participants
Interval 79.19 to 91.44
|
90.3 percentage of participants
Interval 84.54 to 94.48
|
74.3 percentage of participants
Interval 66.5 to 81.15
|
88.4 percentage of participants
Interval 82.01 to 93.07
|
88.1 percentage of participants
Interval 82.93 to 92.15
|
|
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
1 (n = 138, 155, 148, 147, 210)
|
94.2 percentage of participants
Interval 88.9 to 97.46
|
97.4 percentage of participants
Interval 93.52 to 99.29
|
90.5 percentage of participants
Interval 84.64 to 94.73
|
94.6 percentage of participants
Interval 89.56 to 97.62
|
94.3 percentage of participants
Interval 90.23 to 97.01
|
|
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
3 (n = 138, 155, 148, 147, 210)
|
83.3 percentage of participants
Interval 76.05 to 89.13
|
89.7 percentage of participants
Interval 83.78 to 93.98
|
81.1 percentage of participants
Interval 73.83 to 87.05
|
88.4 percentage of participants
Interval 82.13 to 93.12
|
91.0 percentage of participants
Interval 86.23 to 94.46
|
|
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
5 (n = 137, 155, 148, 146, 210)
|
84.7 percentage of participants
Interval 77.53 to 90.25
|
91.0 percentage of participants
Interval 85.31 to 94.97
|
76.4 percentage of participants
Interval 68.68 to 82.94
|
89.7 percentage of participants
Interval 83.62 to 94.13
|
84.3 percentage of participants
Interval 78.65 to 88.93
|
|
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
6A (n = 138, 155, 148, 146, 210)
|
86.2 percentage of participants
Interval 79.34 to 91.5
|
92.3 percentage of participants
Interval 86.87 to 95.94
|
83.1 percentage of participants
Interval 76.08 to 88.76
|
91.8 percentage of participants
Interval 86.08 to 95.68
|
91.9 percentage of participants
Interval 87.36 to 95.21
|
|
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
7F (n = 138, 155, 148, 146, 210)
|
100.0 percentage of participants
Interval 97.36 to 100.0
|
99.4 percentage of participants
Interval 96.46 to 99.98
|
97.3 percentage of participants
Interval 93.22 to 99.26
|
100.0 percentage of participants
Interval 97.51 to 100.0
|
99.5 percentage of participants
Interval 97.38 to 99.99
|
|
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
19A (n = 137, 155, 148, 146, 210)
|
98.5 percentage of participants
Interval 94.83 to 99.82
|
99.4 percentage of participants
Interval 96.46 to 99.98
|
98.0 percentage of participants
Interval 94.19 to 99.58
|
99.3 percentage of participants
Interval 96.24 to 99.98
|
100.0 percentage of participants
Interval 98.26 to 100.0
|
SECONDARY outcome
Timeframe: 1 month after the toddler dosePopulation: mITT toddler immunogenicity set: eligible participants who had \>=1 valid,determinate assay result, 56-98 days of age at Vaccination 1, received antipyretic regimen as per randomization, received all vaccinations, may have had received additional anti-pyretic medication, had blood drawn within specified time frames, had no major protocol violations.
Antibody geometric LS mean concentrations (GMCs) for 13 pneumococcal serotypes (4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies participants with a determinate IgG concentration to the given serotype for each arm respectively.
Outcome measures
| Measure |
13vPnC + INFANRIX Hexa + Paracetamol Twice Daily
n=130 Participants
Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (greater than or equal to \[\>=\]56 to less than or equal to \[\<=\]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
|
13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily
n=144 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
|
13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily
n=143 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
|
13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily
n=139 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
|
13vPnC + INFANRIX Hexa
n=206 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
|
|---|---|---|---|---|---|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose
4 (n = 130, 144, 143, 139, 206)
|
3.07 mcg/mL
Interval 2.66 to 3.54
|
3.43 mcg/mL
Interval 3.0 to 3.93
|
2.97 mcg/mL
Interval 2.6 to 3.41
|
3.43 mcg/mL
Interval 2.99 to 3.94
|
3.10 mcg/mL
Interval 2.77 to 3.48
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose
6B (n = 130, 144, 143, 139, 206)
|
6.70 mcg/mL
Interval 5.76 to 7.78
|
8.01 mcg/mL
Interval 6.94 to 9.24
|
6.38 mcg/mL
Interval 5.53 to 7.36
|
7.30 mcg/mL
Interval 6.31 to 8.44
|
7.08 mcg/mL
Interval 6.28 to 7.98
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose
9V (n = 130, 144, 143, 139, 206)
|
2.15 mcg/mL
Interval 1.93 to 2.4
|
2.23 mcg/mL
Interval 2.01 to 2.47
|
2.17 mcg/mL
Interval 1.96 to 2.41
|
2.12 mcg/mL
Interval 1.91 to 2.35
|
2.16 mcg/mL
Interval 1.99 to 2.36
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose
14 (n = 130, 144, 143, 139, 206)
|
8.10 mcg/mL
Interval 7.04 to 9.31
|
8.40 mcg/mL
Interval 7.36 to 9.59
|
7.95 mcg/mL
Interval 6.96 to 9.08
|
9.12 mcg/mL
Interval 7.96 to 10.43
|
9.10 mcg/mL
Interval 8.15 to 10.17
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose
18C (n = 130, 144, 143, 139, 206)
|
1.35 mcg/mL
Interval 1.2 to 1.53
|
1.68 mcg/mL
Interval 1.49 to 1.88
|
1.36 mcg/mL
Interval 1.21 to 1.53
|
1.63 mcg/mL
Interval 1.45 to 1.84
|
1.59 mcg/mL
Interval 1.44 to 1.75
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose
19F (n = 130, 144, 143, 139, 206)
|
8.41 mcg/mL
Interval 7.17 to 9.87
|
8.99 mcg/mL
Interval 7.72 to 10.46
|
7.53 mcg/mL
Interval 6.47 to 8.76
|
8.02 mcg/mL
Interval 6.88 to 9.36
|
7.95 mcg/mL
Interval 7.0 to 9.02
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose
23F (n = 130, 144, 142, 139, 206)
|
2.34 mcg/mL
Interval 2.01 to 2.73
|
2.96 mcg/mL
Interval 2.56 to 3.43
|
2.37 mcg/mL
Interval 2.05 to 2.75
|
2.86 mcg/mL
Interval 2.47 to 3.32
|
2.75 mcg/mL
Interval 2.43 to 3.1
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose
1 (n = 130, 144, 143, 139, 206)
|
2.80 mcg/mL
Interval 2.47 to 3.17
|
3.22 mcg/mL
Interval 2.85 to 3.62
|
2.66 mcg/mL
Interval 2.36 to 3.0
|
3.12 mcg/mL
Interval 2.76 to 3.52
|
3.04 mcg/mL
Interval 2.75 to 3.35
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose
3 (n = 129, 144, 143, 138, 203)
|
0.46 mcg/mL
Interval 0.4 to 0.52
|
0.54 mcg/mL
Interval 0.47 to 0.61
|
0.46 mcg/mL
Interval 0.4 to 0.52
|
0.49 mcg/mL
Interval 0.42 to 0.55
|
0.54 mcg/mL
Interval 0.48 to 0.6
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose
5 (n = 130, 144, 143, 139, 206)
|
2.33 mcg/mL
Interval 2.07 to 2.63
|
2.75 mcg/mL
Interval 2.46 to 3.07
|
2.40 mcg/mL
Interval 2.15 to 2.69
|
2.62 mcg/mL
Interval 2.33 to 2.93
|
2.84 mcg/mL
Interval 2.59 to 3.12
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose
6A (n = 130, 144, 143, 139, 206)
|
5.12 mcg/mL
Interval 4.48 to 5.86
|
5.73 mcg/mL
Interval 5.04 to 6.5
|
5.27 mcg/mL
Interval 4.64 to 5.99
|
5.36 mcg/mL
Interval 4.7 to 6.1
|
5.52 mcg/mL
Interval 4.97 to 6.14
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose
7F (n = 130, 144, 142, 139, 206)
|
3.79 mcg/mL
Interval 3.42 to 4.19
|
3.89 mcg/mL
Interval 3.54 to 4.28
|
3.56 mcg/mL
Interval 3.23 to 3.92
|
3.97 mcg/mL
Interval 3.6 to 4.38
|
3.98 mcg/mL
Interval 3.67 to 4.31
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose
19A (n = 129, 144, 142, 139, 206)
|
7.11 mcg/mL
Interval 6.22 to 8.12
|
7.99 mcg/mL
Interval 7.04 to 9.06
|
7.31 mcg/mL
Interval 6.43 to 8.3
|
7.35 mcg/mL
Interval 6.47 to 8.36
|
7.71 mcg/mL
Interval 6.94 to 8.57
|
SECONDARY outcome
Timeframe: 1 month after the infant seriesPopulation: mITT infant immunogenicity population. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies participants with a determinate IgG concentration to the given serotype for each arm respectively.
Percentage of participants achieving serotype-specific pneumococcal OPA titer \>= LLOQ, along with the corresponding 95% CIs for 13 pneumococcal serotypes (4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants. The OPA LLOQ in titers for each serotype: 1 = 1:18; 3 = 1:12; 4 = 1:21; 5 = 1:29; 6A = 1:37; 6B = 1:43; 7F = 1:210; 9V = 1:345; 14 = 1:35; 18C = 1:31; 19A = 1:18; 19F = 1:48; 23F = 1:13.
Outcome measures
| Measure |
13vPnC + INFANRIX Hexa + Paracetamol Twice Daily
n=46 Participants
Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (greater than or equal to \[\>=\]56 to less than or equal to \[\<=\]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
|
13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily
n=48 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
|
13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily
n=44 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
|
13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily
n=44 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
|
13vPnC + INFANRIX Hexa
n=76 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
|
|---|---|---|---|---|---|
|
Percentage of Participants Achieving Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After the Infant Series
4 (n = 37, 46, 42, 41, 61)
|
100.0 percentage of participants
Interval 90.5 to 100.0
|
100.0 percentage of participants
Interval 92.3 to 100.0
|
100.0 percentage of participants
Interval 91.6 to 100.0
|
100.0 percentage of participants
Interval 91.4 to 100.0
|
100.0 percentage of participants
Interval 94.1 to 100.0
|
|
Percentage of Participants Achieving Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After the Infant Series
6B (n = 36, 45, 43, 40, 62)
|
94.4 percentage of participants
Interval 81.3 to 99.3
|
88.9 percentage of participants
Interval 75.9 to 96.3
|
88.4 percentage of participants
Interval 74.9 to 96.1
|
92.5 percentage of participants
Interval 79.6 to 98.4
|
96.8 percentage of participants
Interval 88.8 to 99.6
|
|
Percentage of Participants Achieving Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After the Infant Series
9V (n = 37, 48, 42, 41, 65)
|
62.2 percentage of participants
Interval 44.8 to 77.5
|
66.7 percentage of participants
Interval 51.6 to 79.6
|
59.5 percentage of participants
Interval 43.3 to 74.4
|
80.5 percentage of participants
Interval 65.1 to 91.2
|
75.4 percentage of participants
Interval 63.1 to 85.2
|
|
Percentage of Participants Achieving Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After the Infant Series
14 (n = 38, 48, 41, 41, 64)
|
89.5 percentage of participants
Interval 75.2 to 97.1
|
97.9 percentage of participants
Interval 88.9 to 99.9
|
100.0 percentage of participants
Interval 91.4 to 100.0
|
97.6 percentage of participants
Interval 87.1 to 99.9
|
96.9 percentage of participants
Interval 89.2 to 99.6
|
|
Percentage of Participants Achieving Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After the Infant Series
18C (n = 37, 47, 41, 41, 62)
|
100.0 percentage of participants
Interval 90.5 to 100.0
|
95.7 percentage of participants
Interval 85.5 to 99.5
|
100.0 percentage of participants
Interval 91.4 to 100.0
|
97.6 percentage of participants
Interval 87.1 to 99.9
|
100.0 percentage of participants
Interval 94.2 to 100.0
|
|
Percentage of Participants Achieving Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After the Infant Series
19F (n = 37, 46, 41, 42, 63)
|
97.3 percentage of participants
Interval 85.8 to 99.9
|
87.0 percentage of participants
Interval 73.7 to 95.1
|
90.2 percentage of participants
Interval 76.9 to 97.3
|
92.9 percentage of participants
Interval 80.5 to 98.5
|
95.2 percentage of participants
Interval 86.7 to 99.0
|
|
Percentage of Participants Achieving Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After the Infant Series
23F (n = 38, 45, 42, 42, 63)
|
92.1 percentage of participants
Interval 78.6 to 98.3
|
97.8 percentage of participants
Interval 88.2 to 99.9
|
92.9 percentage of participants
Interval 80.5 to 98.5
|
90.5 percentage of participants
Interval 77.4 to 97.3
|
93.7 percentage of participants
Interval 84.5 to 98.2
|
|
Percentage of Participants Achieving Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After the Infant Series
1 (n = 42, 42, 43, 44, 74)
|
47.6 percentage of participants
Interval 32.0 to 63.6
|
42.9 percentage of participants
Interval 27.7 to 59.0
|
30.2 percentage of participants
Interval 17.2 to 46.1
|
29.5 percentage of participants
Interval 16.8 to 45.2
|
45.9 percentage of participants
Interval 34.3 to 57.9
|
|
Percentage of Participants Achieving Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After the Infant Series
3 (n = 41, 41, 39, 39, 69)
|
97.6 percentage of participants
Interval 87.1 to 99.9
|
97.6 percentage of participants
Interval 87.1 to 99.9
|
97.4 percentage of participants
Interval 86.5 to 99.9
|
94.9 percentage of participants
Interval 82.7 to 99.4
|
100.0 percentage of participants
Interval 94.8 to 100.0
|
|
Percentage of Participants Achieving Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After the Infant Series
5 (n = 42, 43, 44, 42, 73)
|
92.9 percentage of participants
Interval 80.5 to 98.5
|
90.7 percentage of participants
Interval 77.9 to 97.4
|
86.4 percentage of participants
Interval 72.6 to 94.8
|
92.9 percentage of participants
Interval 80.5 to 98.5
|
86.3 percentage of participants
Interval 76.2 to 93.2
|
|
Percentage of Participants Achieving Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After the Infant Series
6A (n = 46, 42, 39, 39, 76)
|
93.5 percentage of participants
Interval 82.1 to 98.6
|
100.0 percentage of participants
Interval 91.6 to 100.0
|
100.0 percentage of participants
Interval 91.0 to 100.0
|
100.0 percentage of participants
Interval 91.0 to 100.0
|
98.7 percentage of participants
Interval 92.9 to 100.0
|
|
Percentage of Participants Achieving Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After the Infant Series
7F (n = 46, 42, 40, 39, 76)
|
100.0 percentage of participants
Interval 92.3 to 100.0
|
100.0 percentage of participants
Interval 91.6 to 100.0
|
100.0 percentage of participants
Interval 91.2 to 100.0
|
97.4 percentage of participants
Interval 86.5 to 99.9
|
100.0 percentage of participants
Interval 95.3 to 100.0
|
|
Percentage of Participants Achieving Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After the Infant Series
19A (n = 42, 44, 41, 42, 74)
|
92.9 percentage of participants
Interval 80.5 to 98.5
|
100.0 percentage of participants
Interval 92.0 to 100.0
|
90.2 percentage of participants
Interval 76.9 to 97.3
|
88.1 percentage of participants
Interval 74.4 to 96.0
|
97.3 percentage of participants
Interval 90.6 to 99.7
|
SECONDARY outcome
Timeframe: 1 month after the infant seriesPopulation: mITT infant immunogenicity population. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies participants with a determinate OPA titer to the given serotype for each arm respectively.
Antibody-mediated serum OPA against the 13 pneumococcal serotypes (4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F and 19A) was measured centrally using a pneumococcal OPA assay. Results were expressed as OPA titers. OPA titers were logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs).
Outcome measures
| Measure |
13vPnC + INFANRIX Hexa + Paracetamol Twice Daily
n=46 Participants
Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (greater than or equal to \[\>=\]56 to less than or equal to \[\<=\]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
|
13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily
n=48 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
|
13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily
n=44 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
|
13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily
n=44 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
|
13vPnC + INFANRIX Hexa
n=76 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
|
|---|---|---|---|---|---|
|
Geometric Mean Titer (GMT) for Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) 1 Month After the Infant Series
4 (n = 37, 46, 42, 41, 61)
|
1269 titer
Interval 961.2 to 1674.2
|
1135 titer
Interval 885.2 to 1456.1
|
1240 titer
Interval 955.9 to 1609.3
|
1361 titer
Interval 1045.4 to 1771.0
|
1086 titer
Interval 874.9 to 1347.9
|
|
Geometric Mean Titer (GMT) for Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) 1 Month After the Infant Series
6B (n = 36, 45, 43, 40, 62)
|
794 titer
Interval 450.4 to 1399.6
|
655 titer
Interval 394.6 to 1087.9
|
470 titer
Interval 279.9 to 789.7
|
663 titer
Interval 387.2 to 1135.1
|
748 titer
Interval 485.6 to 1152.0
|
|
Geometric Mean Titer (GMT) for Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) 1 Month After the Infant Series
9V (n = 37, 48, 42, 41, 65)
|
120 titer
Interval 52.5 to 274.2
|
166 titer
Interval 80.5 to 343.3
|
93 titer
Interval 43.0 to 203.0
|
285 titer
Interval 129.8 to 623.8
|
241 titer
Interval 129.0 to 448.7
|
|
Geometric Mean Titer (GMT) for Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) 1 Month After the Infant Series
14 (n = 38, 48, 41, 41, 64)
|
435 titer
Interval 277.2 to 683.5
|
622 titer
Interval 416.0 to 928.6
|
650 titer
Interval 420.7 to 1003.0
|
991 titer
Interval 642.1 to 1530.9
|
951 titer
Interval 671.6 to 1346.3
|
|
Geometric Mean Titer (GMT) for Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) 1 Month After the Infant Series
18C (n = 37, 47, 41, 41, 62)
|
1094 titer
Interval 777.8 to 1539.2
|
853 titer
Interval 630.0 to 1154.3
|
877 titer
Interval 634.1 to 1212.7
|
1031 titer
Interval 745.8 to 1426.2
|
1092 titer
Interval 838.9 to 1421.3
|
|
Geometric Mean Titer (GMT) for Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) 1 Month After the Infant Series
19F (n = 37, 46, 41, 42, 63)
|
346 titer
Interval 219.7 to 545.4
|
221 titer
Interval 146.8 to 331.9
|
165 titer
Interval 106.8 to 253.4
|
294 titer
Interval 191.8 to 450.2
|
279 titer
Interval 196.8 to 395.0
|
|
Geometric Mean Titer (GMT) for Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) 1 Month After the Infant Series
23F (n = 38, 45, 42, 42, 63)
|
342 titer
Interval 211.6 to 552.6
|
441 titer
Interval 283.7 to 685.4
|
332 titer
Interval 210.0 to 523.4
|
321 titer
Interval 203.3 to 506.7
|
366 titer
Interval 252.4 to 532.1
|
|
Geometric Mean Titer (GMT) for Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) 1 Month After the Infant Series
1 (n = 42, 42, 43, 44, 74)
|
12 titer
Interval 8.7 to 17.7
|
11 titer
Interval 7.5 to 15.4
|
8 titer
Interval 5.5 to 11.2
|
8 titer
Interval 5.4 to 10.9
|
12 titer
Interval 9.0 to 15.5
|
|
Geometric Mean Titer (GMT) for Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) 1 Month After the Infant Series
3 (n = 41, 41, 39, 39, 69)
|
72 titer
Interval 57.4 to 91.1
|
76 titer
Interval 60.4 to 95.7
|
56 titer
Interval 44.1 to 70.8
|
62 titer
Interval 49.3 to 79.1
|
87 titer
Interval 73.1 to 104.3
|
|
Geometric Mean Titer (GMT) for Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) 1 Month After the Infant Series
5 (n = 42, 43, 44, 42, 73)
|
86 titer
Interval 59.7 to 122.7
|
96 titer
Interval 67.4 to 137.3
|
54 titer
Interval 37.7 to 76.2
|
99 titer
Interval 69.1 to 142.0
|
76 titer
Interval 57.5 to 99.2
|
|
Geometric Mean Titer (GMT) for Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) 1 Month After the Infant Series
6A (n = 46, 42, 39, 39, 76)
|
1060 titer
Interval 784.5 to 1431.1
|
1681 titer
Interval 1227.3 to 2302.3
|
1228 titer
Interval 886.0 to 1701.9
|
1281 titer
Interval 924.0 to 1775.1
|
1462 titer
Interval 1157.1 to 1847.1
|
|
Geometric Mean Titer (GMT) for Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) 1 Month After the Infant Series
7F (n = 46, 42, 40, 39, 76)
|
1766 titer
Interval 1387.0 to 2247.7
|
1907 titer
Interval 1481.0 to 2454.6
|
1747 titer
Interval 1348.6 to 2263.3
|
1584 titer
Interval 1218.8 to 2058.9
|
2125 titer
Interval 1761.6 to 2564.6
|
|
Geometric Mean Titer (GMT) for Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) 1 Month After the Infant Series
19A (n = 42, 44, 41, 42, 74)
|
185 titer
Interval 127.8 to 268.3
|
257 titer
Interval 178.5 to 368.5
|
163 titer
Interval 112.3 to 237.9
|
159 titer
Interval 110.0 to 230.9
|
240 titer
Interval 181.9 to 318.0
|
SECONDARY outcome
Timeframe: 1 month after the infant seriesPopulation: mITT infant immunogenicity population. Here 'N' (number of participants analyzed) signifies participants with a determinate antibody concentration to the given concomitant vaccine antigen.
Geometric LS mean concentrations (GMCs) and corresponding 2-sided 95% CIs were evaluated for Hib PRP antibody.
Outcome measures
| Measure |
13vPnC + INFANRIX Hexa + Paracetamol Twice Daily
n=136 Participants
Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (greater than or equal to \[\>=\]56 to less than or equal to \[\<=\]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
|
13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily
n=146 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
|
13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily
n=144 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
|
13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily
n=139 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
|
13vPnC + INFANRIX Hexa
n=198 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
|
|---|---|---|---|---|---|
|
Geometric Mean Concentration (GMC) for Antigen-specific Haemophilus Influenzae Type b (Hib) Polyribosylribitol Phosphate (PRP) Antibody 1 Month After the Infant Series
|
0.54 mcg/mL
Interval 0.44 to 0.66
|
0.59 mcg/mL
Interval 0.49 to 0.73
|
0.49 mcg/mL
Interval 0.4 to 0.6
|
0.51 mcg/mL
Interval 0.42 to 0.63
|
0.58 mcg/mL
Interval 0.49 to 0.69
|
SECONDARY outcome
Timeframe: 1 month after the infant seriesPopulation: mITT infant immunogenicity population. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Geometric LS mean concentration (GMCs) were measured in Enzyme-linked Immunosorbent Assay (ELISA) units/mL (EU/mL) and corresponding 2-sided 95% CIs were evaluated for pertussis (pertussis toxin \[PT\], filamentous hemagglutinin \[FHA\] and pertactin \[PRN\]) antibodies.
Outcome measures
| Measure |
13vPnC + INFANRIX Hexa + Paracetamol Twice Daily
n=132 Participants
Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (greater than or equal to \[\>=\]56 to less than or equal to \[\<=\]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
|
13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily
n=143 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
|
13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily
n=141 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
|
13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily
n=131 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
|
13vPnC + INFANRIX Hexa
n=193 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
|
|---|---|---|---|---|---|
|
Geometric Mean Concentration (GMC) for Antigen-specific Pertussis Toxin (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antibody 1 Month After the Infant Series
Pertussis PT
|
40.86 EU/mL
Interval 36.49 to 45.76
|
43.51 EU/mL
Interval 39.02 to 48.51
|
40.27 EU/mL
Interval 36.09 to 44.93
|
39.26 EU/mL
Interval 35.04 to 43.98
|
44.85 EU/mL
Interval 40.84 to 49.25
|
|
Geometric Mean Concentration (GMC) for Antigen-specific Pertussis Toxin (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antibody 1 Month After the Infant Series
Pertussis FHA
|
46.29 EU/mL
Interval 41.49 to 51.65
|
40.65 EU/mL
Interval 36.59 to 45.16
|
41.32 EU/mL
Interval 37.16 to 45.94
|
35.55 EU/mL
Interval 31.85 to 39.68
|
48.42 EU/mL
Interval 44.22 to 53.01
|
|
Geometric Mean Concentration (GMC) for Antigen-specific Pertussis Toxin (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antibody 1 Month After the Infant Series
Pertussis PRN
|
72.90 EU/mL
Interval 63.26 to 84.01
|
71.26 EU/mL
Interval 62.18 to 81.66
|
65.82 EU/mL
Interval 57.38 to 75.5
|
68.53 EU/mL
Interval 59.44 to 79.02
|
84.57 EU/mL
Interval 75.21 to 95.09
|
SECONDARY outcome
Timeframe: 1 month after the infant seriesPopulation: mITT infant immunogenicity population. Here 'N' (number of participants analyzed) signifies participants with a determinate antibody concentration to the given concomitant vaccine antigen.
Geometric LS mean concentration (GMCs) were measured in International Units/mL (IU/mL) and corresponding 2-sided 95% CIs were evaluated for tetanus and diphtheria antibodies.
Outcome measures
| Measure |
13vPnC + INFANRIX Hexa + Paracetamol Twice Daily
n=132 Participants
Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (greater than or equal to \[\>=\]56 to less than or equal to \[\<=\]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
|
13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily
n=143 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
|
13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily
n=141 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
|
13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily
n=131 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
|
13vPnC + INFANRIX Hexa
n=193 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
|
|---|---|---|---|---|---|
|
Geometric Mean Concentration (GMC) for Antigen-specific Tetanus and Diphtheria Antibody 1 Month After the Infant Series
Tetanus
|
0.73 IU/mL
Interval 0.65 to 0.83
|
0.70 IU/mL
Interval 0.62 to 0.79
|
0.69 IU/mL
Interval 0.61 to 0.77
|
0.60 IU/mL
Interval 0.53 to 0.68
|
0.82 IU/mL
Interval 0.74 to 0.9
|
|
Geometric Mean Concentration (GMC) for Antigen-specific Tetanus and Diphtheria Antibody 1 Month After the Infant Series
Diphtheria
|
0.62 IU/mL
Interval 0.56 to 0.69
|
0.68 IU/mL
Interval 0.61 to 0.75
|
0.61 IU/mL
Interval 0.55 to 0.68
|
0.65 IU/mL
Interval 0.59 to 0.73
|
0.65 IU/mL
Interval 0.6 to 0.72
|
SECONDARY outcome
Timeframe: 1 month after the infant seriesPopulation: mITT infant immunogenicity population. Here 'N' (number of participants analyzed) signifies participants with a determinate antibody concentration to the given concomitant vaccine antigen.
Geometric LS mean concentration (GMCs) were measured in milli international units/mL (mIU/mL) and corresponding 2-sided 95% CIs were evaluated for hepatitis B virus (HBV) antibody.
Outcome measures
| Measure |
13vPnC + INFANRIX Hexa + Paracetamol Twice Daily
n=105 Participants
Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (greater than or equal to \[\>=\]56 to less than or equal to \[\<=\]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
|
13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily
n=116 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
|
13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily
n=120 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
|
13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily
n=112 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
|
13vPnC + INFANRIX Hexa
n=156 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
|
|---|---|---|---|---|---|
|
Geometric Mean Concentration (GMC) for Antigen-specific Hepatitis B Virus (HBV) Antibody 1 Month After the Infant Series
|
756.42 mIU/mL
Interval 589.71 to 970.26
|
770.93 mIU/mL
Interval 608.34 to 976.98
|
689.34 mIU/mL
Interval 546.12 to 870.11
|
599.12 mIU/mL
Interval 470.78 to 762.43
|
733.29 mIU/mL
Interval 597.81 to 899.46
|
SECONDARY outcome
Timeframe: 1 month after the infant seriesPopulation: mITT infant immunogenicity population. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Geometric LS mean concentrations (GMCs) were measured as titers and corresponding 2-sided 95% CIs were evaluated for poliomyelitis type 1, 2 and 3 antibodies.
Outcome measures
| Measure |
13vPnC + INFANRIX Hexa + Paracetamol Twice Daily
n=89 Participants
Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (greater than or equal to \[\>=\]56 to less than or equal to \[\<=\]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
|
13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily
n=105 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
|
13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily
n=93 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
|
13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily
n=84 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
|
13vPnC + INFANRIX Hexa
n=135 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
|
|---|---|---|---|---|---|
|
Geometric Mean Titer (GMT) for Antigen-specific Poliomyelitis Type 1, 2 and 3 Antibodies 1 Month After the Infant Series
Poliomyelitis Type 1
|
68.11 titer
Interval 53.14 to 87.3
|
66.59 titer
Interval 52.98 to 83.68
|
67.43 titer
Interval 52.89 to 85.96
|
70.66 titer
Interval 54.73 to 91.23
|
72.02 titer
Interval 58.88 to 88.1
|
|
Geometric Mean Titer (GMT) for Antigen-specific Poliomyelitis Type 1, 2 and 3 Antibodies 1 Month After the Infant Series
Poliomyelitis Type 2
|
79.60 titer
Interval 61.54 to 102.95
|
73.52 titer
Interval 58.01 to 93.16
|
62.12 titer
Interval 48.3 to 79.9
|
55.17 titer
Interval 42.33 to 71.89
|
67.37 titer
Interval 54.67 to 83.02
|
|
Geometric Mean Titer (GMT) for Antigen-specific Poliomyelitis Type 1, 2 and 3 Antibodies 1 Month After the Infant Series
Poliomyelitis Type 3
|
246.22 titer
Interval 192.84 to 314.38
|
184.03 titer
Interval 146.96 to 230.46
|
257.92 titer
Interval 203.08 to 327.56
|
218.85 titer
Interval 170.18 to 281.44
|
231.02 titer
Interval 189.44 to 281.72
|
SECONDARY outcome
Timeframe: 1 month after the toddler dosePopulation: mITT toddler immunogenicity population. Here 'N' (number of participants analyzed) signifies participants with a determinate antibody concentration to the given concomitant vaccine antigen.
Geometric LS mean concentration (GMCs) were measured in mcg/mL and corresponding 2-sided 95% CIs were evaluated for Hib PRP antibody.
Outcome measures
| Measure |
13vPnC + INFANRIX Hexa + Paracetamol Twice Daily
n=126 Participants
Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (greater than or equal to \[\>=\]56 to less than or equal to \[\<=\]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
|
13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily
n=135 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
|
13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily
n=141 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
|
13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily
n=138 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
|
13vPnC + INFANRIX Hexa
n=202 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
|
|---|---|---|---|---|---|
|
Geometric Mean Concentration (GMC) for Antigen-specific Haemophilus Influenzae Type b (Hib) Polyribosylribitol Phosphate (PRP) Antibody 1 Month After the Toddler Dose
|
9.65 mcg/mL
Interval 7.74 to 12.03
|
9.35 mcg/mL
Interval 7.55 to 11.57
|
8.25 mcg/mL
Interval 6.69 to 10.16
|
7.84 mcg/mL
Interval 6.35 to 9.68
|
8.96 mcg/mL
Interval 7.53 to 10.67
|
SECONDARY outcome
Timeframe: 1 month after the toddler dosePopulation: mITT toddler immunogenicity population. Here 'N' (number of participants analyzed) signifies participants with a determinate antibody concentration to the given concomitant vaccine antigen.
Geometric LS mean concentration (GMCs) were measured in EU/mL and corresponding 2-sided 95% CIs were evaluated for pertussis (pertussis toxin \[PT\], filamentous hemagglutinin \[FHA\] and pertactin \[PRN\]) antibodies.
Outcome measures
| Measure |
13vPnC + INFANRIX Hexa + Paracetamol Twice Daily
n=123 Participants
Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (greater than or equal to \[\>=\]56 to less than or equal to \[\<=\]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
|
13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily
n=137 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
|
13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily
n=141 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
|
13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily
n=136 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
|
13vPnC + INFANRIX Hexa
n=199 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
|
|---|---|---|---|---|---|
|
Geometric Mean Concentration (GMC) for Antigen-specific Pertussis Toxin (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antibodies 1 Month After the Toddler Dose
Pertussis PT
|
77.43 EU/mL
Interval 68.12 to 88.02
|
76.93 EU/mL
Interval 68.13 to 86.87
|
73.72 EU/mL
Interval 65.4 to 83.1
|
73.38 EU/mL
Interval 64.96 to 82.9
|
74.01 EU/mL
Interval 66.91 to 81.86
|
|
Geometric Mean Concentration (GMC) for Antigen-specific Pertussis Toxin (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antibodies 1 Month After the Toddler Dose
Pertussis FHA
|
115.55 EU/mL
Interval 104.32 to 128.0
|
117.87 EU/mL
Interval 106.98 to 129.87
|
123.56 EU/mL
Interval 112.3 to 135.95
|
108.11 EU/mL
Interval 98.09 to 119.16
|
117.01 EU/mL
Interval 107.97 to 126.81
|
|
Geometric Mean Concentration (GMC) for Antigen-specific Pertussis Toxin (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antibodies 1 Month After the Toddler Dose
Pertussis PRN
|
158.28 EU/mL
Interval 136.3 to 183.81
|
156.98 EU/mL
Interval 136.24 to 180.87
|
160.96 EU/mL
Interval 139.98 to 185.08
|
158.71 EU/mL
Interval 137.67 to 182.97
|
172.80 EU/mL
Interval 153.64 to 194.36
|
SECONDARY outcome
Timeframe: 1 month after the toddler dosePopulation: mITT toddler immunogenicity population. Here 'N' (number of participants analyzed) signifies participants with a determinate antibody concentration to the given concomitant vaccine antigen.
Geometric LS mean concentration (GMCs) were measured in IU/mL and corresponding 2-sided 95% CIs were evaluated for tetanus and diphtheria antibodies.
Outcome measures
| Measure |
13vPnC + INFANRIX Hexa + Paracetamol Twice Daily
n=123 Participants
Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (greater than or equal to \[\>=\]56 to less than or equal to \[\<=\]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
|
13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily
n=137 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
|
13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily
n=141 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
|
13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily
n=136 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
|
13vPnC + INFANRIX Hexa
n=199 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
|
|---|---|---|---|---|---|
|
Geometric Mean Concentration (GMC) for Antigen-specific Tetanus and Diphtheria Antibodies 1 Month After the Toddler Dose
Tetanus
|
2.54 IU/mL
Interval 2.28 to 2.83
|
2.50 IU/mL
Interval 2.26 to 2.77
|
2.60 IU/mL
Interval 2.35 to 2.88
|
2.29 IU/mL
Interval 2.07 to 2.54
|
2.66 IU/mL
Interval 2.44 to 2.89
|
|
Geometric Mean Concentration (GMC) for Antigen-specific Tetanus and Diphtheria Antibodies 1 Month After the Toddler Dose
Diphtheria
|
1.64 IU/mL
Interval 1.49 to 1.8
|
1.94 IU/mL
Interval 1.77 to 2.12
|
1.69 IU/mL
Interval 1.54 to 1.84
|
1.87 IU/mL
Interval 1.71 to 2.04
|
1.90 IU/mL
Interval 1.77 to 2.05
|
SECONDARY outcome
Timeframe: 1 month after the toddler dosePopulation: mITT toddler immunogenicity population. Here 'N' (number of participants analyzed) signifies participants with a determinate antibody concentration to the given concomitant vaccine antigen.
Geometric LS mean concentration (GMCs) were measured in mIU/mL and corresponding 2-sided 95% CIs were evaluated for hepatitis B virus (HBV) antibody.
Outcome measures
| Measure |
13vPnC + INFANRIX Hexa + Paracetamol Twice Daily
n=119 Participants
Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (greater than or equal to \[\>=\]56 to less than or equal to \[\<=\]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
|
13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily
n=131 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
|
13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily
n=133 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
|
13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily
n=133 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
|
13vPnC + INFANRIX Hexa
n=191 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
|
|---|---|---|---|---|---|
|
Geometric Mean Concentration (GMC) for Antigen-specific Hepatitis B Virus (HBV) Antibody 1 Month After the Toddler Dose
|
4868.61 mIU/mL
Interval 3750.57 to 6319.94
|
4148.04 mIU/mL
Interval 3234.82 to 5319.08
|
4250.41 mIU/mL
Interval 3320.88 to 5440.13
|
4263.28 mIU/mL
Interval 3330.93 to 5456.6
|
3866.37 mIU/mL
Interval 3146.78 to 4750.52
|
SECONDARY outcome
Timeframe: 1 month after the toddler dosePopulation: mITT toddler immunogenicity population. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Geometric LS mean concentration (GMCs) were measured as titers and corresponding 2-sided 95% CIs were evaluated for poliomyelitis type 1, 2 and 3 antibodies.
Outcome measures
| Measure |
13vPnC + INFANRIX Hexa + Paracetamol Twice Daily
n=123 Participants
Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (greater than or equal to \[\>=\]56 to less than or equal to \[\<=\]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
|
13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily
n=133 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
|
13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily
n=141 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
|
13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily
n=136 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
|
13vPnC + INFANRIX Hexa
n=201 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
|
|---|---|---|---|---|---|
|
Geometric Mean Titer (GMT) for Antigen-specific Poliomyelitis Type 1, 2 and 3 Antibodies 1 Month After the Toddler Dose
Poliomyelitis Type 1
|
399.56 titer
Interval 332.13 to 480.68
|
426.63 titer
Interval 357.15 to 509.62
|
443.97 titer
Interval 373.58 to 527.63
|
415.45 titer
Interval 348.48 to 495.29
|
406.37 titer
Interval 351.67 to 469.59
|
|
Geometric Mean Titer (GMT) for Antigen-specific Poliomyelitis Type 1, 2 and 3 Antibodies 1 Month After the Toddler Dose
Poliomyelitis Type 2
|
613.18 titer
Interval 515.3 to 729.65
|
586.30 titer
Interval 496.01 to 693.03
|
587.56 titer
Interval 499.47 to 691.18
|
605.78 titer
Interval 513.44 to 714.73
|
621.07 titer
Interval 542.07 to 711.57
|
|
Geometric Mean Titer (GMT) for Antigen-specific Poliomyelitis Type 1, 2 and 3 Antibodies 1 Month After the Toddler Dose
Poliomyelitis Type 3
|
1205.80 titer
Interval 1001.18 to 1452.24
|
1045.57 titer
Interval 874.35 to 1250.32
|
1210.29 titer
Interval 1017.32 to 1439.87
|
1187.11 titer
Interval 994.68 to 1416.76
|
1237.86 titer
Interval 1070.27 to 1431.7
|
SECONDARY outcome
Timeframe: 1 month after the infant seriesPopulation: mITT infant immunogenicity population. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies participants with a determinate antibody concentration or titer to the given concomitant vaccine antigen for each arm respectively.
Percentage of participants achieving pre-specified criteria for concomitant antigens contained in INFANRIX hexa (Hib polyribosylribitol phosphate \[PRP\] \>=0.15 mcg/mL; Hib PRP \>=1 mcg/mL; Pertussis PT \>=14.6 EU/mL, FHA \>=16.1 EU/mL, PRN \>=24.0 EU/mL; Tetanus \>=0.1 IU/mL; Diphtheria \>=0.1 IU/mL; HBV \>=10 mIU/mL; Poliomyelitis Type 1, 2, 3 \>=1:8 titer) along with the corresponding 95% CIs were presented. Exact 2-sided CI based on the observed proportion of participants. Pre-specified criteria for pertussis was the level that 95% of the participants achieved in 13vPnC + INFANRIX hexa group.
Outcome measures
| Measure |
13vPnC + INFANRIX Hexa + Paracetamol Twice Daily
n=136 Participants
Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (greater than or equal to \[\>=\]56 to less than or equal to \[\<=\]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
|
13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily
n=146 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
|
13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily
n=144 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
|
13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily
n=139 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
|
13vPnC + INFANRIX Hexa
n=198 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
|
|---|---|---|---|---|---|
|
Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Infant Series
Hib PRP >=0.15 mcg/mL (n= 136, 146, 144, 139, 198)
|
87.5 percentage of participants
Interval 80.7 to 92.5
|
84.2 percentage of participants
Interval 77.3 to 89.7
|
86.1 percentage of participants
Interval 79.4 to 91.3
|
85.6 percentage of participants
Interval 78.7 to 91.0
|
87.9 percentage of participants
Interval 82.5 to 92.1
|
|
Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Infant Series
Hib PRP >=1 mcg/mL (n = 136, 146, 144, 139, 198)
|
33.8 percentage of participants
Interval 25.9 to 42.4
|
37.0 percentage of participants
Interval 29.2 to 45.4
|
27.1 percentage of participants
Interval 20.0 to 35.1
|
28.1 percentage of participants
Interval 20.8 to 36.3
|
33.8 percentage of participants
Interval 27.3 to 40.9
|
|
Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Infant Series
Pertussis PT >=14.6 EU/mL (n= 132,143,141,131,193)
|
93.2 percentage of participants
Interval 87.5 to 96.8
|
97.2 percentage of participants
Interval 93.0 to 99.2
|
91.5 percentage of participants
Interval 85.6 to 95.5
|
90.8 percentage of participants
Interval 84.5 to 95.2
|
95.3 percentage of participants
Interval 91.3 to 97.8
|
|
Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Infant Series
Pertussis FHA >=16.1 EU/mL (n=132,143,141,131,193)
|
96.2 percentage of participants
Interval 91.4 to 98.8
|
92.3 percentage of participants
Interval 86.7 to 96.1
|
93.6 percentage of participants
Interval 88.2 to 97.0
|
88.5 percentage of participants
Interval 81.8 to 93.4
|
95.3 percentage of participants
Interval 91.3 to 97.8
|
|
Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Infant Series
Pertussis PRN >=24.0 EU/mL (n=132,143,141,131,193)
|
90.9 percentage of participants
Interval 84.7 to 95.2
|
87.4 percentage of participants
Interval 80.8 to 92.4
|
88.7 percentage of participants
Interval 82.2 to 93.4
|
89.3 percentage of participants
Interval 82.7 to 94.0
|
95.3 percentage of participants
Interval 91.3 to 97.8
|
|
Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Infant Series
Tetanus >=0.1 IU/mL (n = 132,143,141,131,193)
|
100.0 percentage of participants
Interval 97.2 to 100.0
|
100.0 percentage of participants
Interval 97.5 to 100.0
|
100.0 percentage of participants
Interval 97.4 to 100.0
|
98.5 percentage of participants
Interval 94.6 to 99.8
|
99.5 percentage of participants
Interval 97.1 to 100.0
|
|
Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Infant Series
Diphtheria >=0.1 IU/mL (n = 132,143,141,131,193)
|
100.0 percentage of participants
Interval 97.2 to 100.0
|
98.6 percentage of participants
Interval 95.0 to 99.8
|
99.3 percentage of participants
Interval 96.1 to 100.0
|
97.7 percentage of participants
Interval 93.5 to 99.5
|
99.5 percentage of participants
Interval 97.1 to 100.0
|
|
Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Infant Series
HBV >= 10mIU/mL (n = 105,116,120,112,156)
|
100.0 percentage of participants
Interval 96.5 to 100.0
|
99.1 percentage of participants
Interval 95.3 to 100.0
|
99.2 percentage of participants
Interval 95.4 to 100.0
|
99.1 percentage of participants
Interval 95.1 to 100.0
|
98.7 percentage of participants
Interval 95.4 to 99.8
|
|
Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Infant Series
PoliomyelitisType1 >=1:8titer (n=89,105,93,84,135)
|
97.8 percentage of participants
Interval 92.1 to 99.7
|
98.1 percentage of participants
Interval 93.3 to 99.8
|
97.8 percentage of participants
Interval 92.4 to 99.7
|
100.0 percentage of participants
Interval 95.7 to 100.0
|
99.3 percentage of participants
Interval 95.9 to 100.0
|
|
Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Infant Series
PoliomyelitisType2 >=1:8titer (n=89,105,93,84,135)
|
95.5 percentage of participants
Interval 88.9 to 98.8
|
98.1 percentage of participants
Interval 93.3 to 99.8
|
95.7 percentage of participants
Interval 89.4 to 98.8
|
96.4 percentage of participants
Interval 89.9 to 99.3
|
95.6 percentage of participants
Interval 90.6 to 98.4
|
|
Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Infant Series
PoliomyelitisType3 >=1:8titer (n=89,105,93,84,135)
|
100.0 percentage of participants
Interval 95.9 to 100.0
|
100.0 percentage of participants
Interval 96.5 to 100.0
|
98.9 percentage of participants
Interval 94.2 to 100.0
|
98.8 percentage of participants
Interval 93.5 to 100.0
|
99.3 percentage of participants
Interval 95.9 to 100.0
|
SECONDARY outcome
Timeframe: 1 month after the toddler dosePopulation: mITT toddler immunogenicity population. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies participants with a determinate antibody concentration or titer to the given concomitant vaccine antigen for each arm respectively.
Percentage of participants achieving pre-specified criteria for concomitant antigens contained in INFANRIX hexa (Hib polyribosylribitol phosphate \[PRP\] \>=0.15 mcg/mL; Hib PRP \>=1 mcg/mL; Pertussis PT \>=14.8 EU/mL, FHA \>=46.5 EU/mL, PRN \>=43.5 EU/mL; Tetanus \>=0.1 IU/mL; Diphtheria \>=0.1 IU/mL; HBV \>=10 mIU/mL; Poliomyelitis Type 1, 2, 3 \>=1:8 titer) along with the corresponding 95% CIs were presented. Exact 2-sided CI based on the observed proportion of participants. Pre-specified criteria for pertussis was the level that 95% of the participants achieved in 13vPnC + INFANRIX hexa group.
Outcome measures
| Measure |
13vPnC + INFANRIX Hexa + Paracetamol Twice Daily
n=126 Participants
Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (greater than or equal to \[\>=\]56 to less than or equal to \[\<=\]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
|
13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily
n=137 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
|
13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily
n=141 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
|
13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily
n=138 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
|
13vPnC + INFANRIX Hexa
n=202 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
|
|---|---|---|---|---|---|
|
Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Toddler Dose
Hib PRP >=0.15 mcg/mL (n= 126, 135, 141, 138, 202)
|
100.0 percentage of participants
Interval 97.1 to 100.0
|
99.3 percentage of participants
Interval 95.9 to 100.0
|
100.0 percentage of participants
Interval 97.4 to 100.0
|
100.0 percentage of participants
Interval 97.4 to 100.0
|
100.0 percentage of participants
Interval 98.2 to 100.0
|
|
Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Toddler Dose
Hib PRP >=1 mcg/mL (n = 126, 135, 141, 138, 202)
|
95.2 percentage of participants
Interval 89.9 to 98.2
|
96.3 percentage of participants
Interval 91.6 to 98.8
|
95.7 percentage of participants
Interval 91.0 to 98.4
|
95.7 percentage of participants
Interval 90.8 to 98.4
|
95.0 percentage of participants
Interval 91.1 to 97.6
|
|
Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Toddler Dose
Pertussis PT >=14.8 EU/mL (n= 123,137,141,136,199)
|
97.6 percentage of participants
Interval 93.0 to 99.5
|
99.3 percentage of participants
Interval 96.0 to 100.0
|
98.6 percentage of participants
Interval 95.0 to 99.8
|
100.0 percentage of participants
Interval 97.3 to 100.0
|
95.5 percentage of participants
Interval 91.6 to 97.9
|
|
Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Toddler Dose
Pertussis FHA >=46.5 EU/mL (n=123,137,141,136,199)
|
91.1 percentage of participants
Interval 84.6 to 95.5
|
94.9 percentage of participants
Interval 89.8 to 97.9
|
93.6 percentage of participants
Interval 88.2 to 97.0
|
92.6 percentage of participants
Interval 86.9 to 96.4
|
95.5 percentage of participants
Interval 91.6 to 97.9
|
|
Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Toddler Dose
Pertussis PRN >=43.5 EU/mL (n=123,137,141,136,199)
|
91.9 percentage of participants
Interval 85.6 to 96.0
|
94.9 percentage of participants
Interval 89.8 to 97.9
|
94.3 percentage of participants
Interval 89.1 to 97.5
|
94.1 percentage of participants
Interval 88.7 to 97.4
|
95.5 percentage of participants
Interval 91.6 to 97.9
|
|
Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Toddler Dose
Tetanus >=0.1 IU/mL (n = 123,137,141,136,199)
|
100.0 percentage of participants
Interval 97.0 to 100.0
|
100.0 percentage of participants
Interval 97.3 to 100.0
|
100.0 percentage of participants
Interval 97.4 to 100.0
|
100.0 percentage of participants
Interval 97.3 to 100.0
|
100.0 percentage of participants
Interval 98.2 to 100.0
|
|
Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Toddler Dose
Diphtheria >=0.1 IU/mL (n = 123,137,141,136,199)
|
100.0 percentage of participants
Interval 97.0 to 100.0
|
100.0 percentage of participants
Interval 97.3 to 100.0
|
100.0 percentage of participants
Interval 97.4 to 100.0
|
100.0 percentage of participants
Interval 97.3 to 100.0
|
100.0 percentage of participants
Interval 98.2 to 100.0
|
|
Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Toddler Dose
HBV >= 10 mIU/mL (n = 119,131,133,133,191)
|
100.0 percentage of participants
Interval 96.9 to 100.0
|
98.5 percentage of participants
Interval 94.6 to 99.8
|
100.0 percentage of participants
Interval 97.3 to 100.0
|
100.0 percentage of participants
Interval 97.3 to 100.0
|
99.5 percentage of participants
Interval 97.1 to 100.0
|
|
Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Toddler Dose
Poliomyelitis 1 >=1:8titer (n=123,133,141,136,201)
|
99.2 percentage of participants
Interval 95.6 to 100.0
|
100.0 percentage of participants
Interval 97.3 to 100.0
|
100.0 percentage of participants
Interval 97.4 to 100.0
|
100.0 percentage of participants
Interval 97.3 to 100.0
|
99.5 percentage of participants
Interval 97.3 to 100.0
|
|
Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Toddler Dose
Poliomyelitis 2 >=1:8titer (n=123,133,141,136,201)
|
100.0 percentage of participants
Interval 97.0 to 100.0
|
100.0 percentage of participants
Interval 97.3 to 100.0
|
100.0 percentage of participants
Interval 97.4 to 100.0
|
100.0 percentage of participants
Interval 97.3 to 100.0
|
100.0 percentage of participants
Interval 98.2 to 100.0
|
|
Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Toddler Dose
Poliomyelitis 3 >=1:8titer (n=123,133,141,136,201)
|
100.0 percentage of participants
Interval 97.0 to 100.0
|
100.0 percentage of participants
Interval 97.3 to 100.0
|
100.0 percentage of participants
Interval 97.4 to 100.0
|
100.0 percentage of participants
Interval 97.3 to 100.0
|
100.0 percentage of participants
Interval 98.2 to 100.0
|
SECONDARY outcome
Timeframe: Within 4 days after infant series Dose 1Population: Safety analysis set Dose 1: participants who received Dose 1 of 13vPnC/INFANRIX hexa in infant series, had Adverse Event (AE) or temperature data. 'N'(number of participants analyzed)=participants reported yes for \>=1 day or no for all days, 'n'=participants reporting yes for \>=1 day or no for all days for specified event for each arm respectively.
Participants' core (rectal) temperature was collected for 4 days after each vaccination using an electronic diary. Participants' temperature was collected at 6 to 8 hours after vaccination, 6 to 8 hours following that and coincidentally with antipyretic administration for groups receiving antipyretics. Temperature was recorded at bedtime daily for 3 following days (Day 2 to Day 4) and at any time during the 3 days when fever was suspected. The highest temperature for each day was recorded in the e-diary. Incidences of fever were presented in following categories: \>=38 but \<=39 degree Celsius (degree C), greater than (\>) 39 but \<=40 degree C and \>40 degree C.
Outcome measures
| Measure |
13vPnC + INFANRIX Hexa + Paracetamol Twice Daily
n=149 Participants
Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (greater than or equal to \[\>=\]56 to less than or equal to \[\<=\]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
|
13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily
n=157 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
|
13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily
n=147 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
|
13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily
n=155 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
|
13vPnC + INFANRIX Hexa
n=187 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
|
|---|---|---|---|---|---|
|
Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 1
Fever >=38, <=39 degree C (n= 149,157,147,155,187)
|
32.9 percentage of participants
|
45.2 percentage of participants
|
18.4 percentage of participants
|
34.2 percentage of participants
|
41.7 percentage of participants
|
|
Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 1
Fever >39, <=40 degree C (n = 138,145,137,146,170)
|
1.4 percentage of participants
|
1.4 percentage of participants
|
0.7 percentage of participants
|
0.7 percentage of participants
|
1.2 percentage of participants
|
|
Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 1
Fever >40 degree C (n = 138,145,137,146,170)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Within 4 days after infant series Dose 2Population: Safety analysis set Dose 2: participants who received Dose 2 of 13vPnC/INFANRIX hexa in infant series and had AE or temperature data available. 'N' (number of participants analyzed) =participants reported yes for \>=1 day or no for all days, 'n'=participants reporting yes for \>=1 day or no for all days for specified event for each arm respectively.
Participants' rectal temperature was collected for 4 days after each vaccination using an electronic diary. Participants' temperature was collected at 6 to 8 hours after vaccination, 6 to 8 hours following that and coincidentally with antipyretic administration for groups receiving antipyretics. Temperature was recorded at bedtime daily for 3 following days (Day 2 to Day 4) and at any time during the 3 days when fever was suspected. The highest temperature for each day was recorded in the e-diary. Incidences of fever were presented in following categories: \>=38 but \<=39 degree C, \>39 but \<=40 degree C and \>40 degree C.
Outcome measures
| Measure |
13vPnC + INFANRIX Hexa + Paracetamol Twice Daily
n=141 Participants
Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (greater than or equal to \[\>=\]56 to less than or equal to \[\<=\]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
|
13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily
n=152 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
|
13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily
n=140 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
|
13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily
n=159 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
|
13vPnC + INFANRIX Hexa
n=181 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
|
|---|---|---|---|---|---|
|
Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 2
Fever >=38, <=39 degree C (n= 141,152,140,159,181)
|
26.2 percentage of participants
|
42.8 percentage of participants
|
21.4 percentage of participants
|
44.0 percentage of participants
|
39.8 percentage of participants
|
|
Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 2
Fever >39, <=40 degree C (n = 133,140,134,145,164)
|
1.5 percentage of participants
|
0.7 percentage of participants
|
1.5 percentage of participants
|
1.4 percentage of participants
|
3.7 percentage of participants
|
|
Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 2
Fever >40 degree C (n = 131,140,133,144,164)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Within 4 days after infant series Dose 3Population: Safety analysis set Dose 3: participants who received Dose 3 of 13vPnC/INFANRIX hexa in infant series and had AE or temperature data available. 'N' (number of participants analyzed) =participants reported yes for \>=1 day or no for all days, 'n'=participants reporting yes for \>=1 day or no for all days for specified event for each arm respectively.
Participants' rectal temperature was collected for 4 days after each vaccination using an electronic diary. Participants' temperature was collected at 6 to 8 hours after vaccination, 6 to 8 hours following that and coincidentally with antipyretic administration for groups receiving antipyretics. Temperature was recorded at bedtime daily for 3 following days (Day 2 to Day 4) and at any time during the 3 days when fever was suspected. The highest temperature for each day was recorded in the e-diary. Incidences of fever were presented in following categories: \>=38 but \<=39 degree C, \>39 but \<=40 degree C and \>40 degree C. Report of fever \>40 degrees C after 13vPnC Infant Series Dose 3 was confirmed as data entry error.
Outcome measures
| Measure |
13vPnC + INFANRIX Hexa + Paracetamol Twice Daily
n=136 Participants
Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (greater than or equal to \[\>=\]56 to less than or equal to \[\<=\]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
|
13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily
n=146 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
|
13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily
n=135 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
|
13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily
n=141 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
|
13vPnC + INFANRIX Hexa
n=175 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
|
|---|---|---|---|---|---|
|
Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 3
Fever >=38, <=39 degree C (n= 136,146,135,141,175)
|
22.1 percentage of participants
|
30.8 percentage of participants
|
17.0 percentage of participants
|
33.3 percentage of participants
|
29.7 percentage of participants
|
|
Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 3
Fever >39, <=40 degree C (n = 129,137,125,136,167)
|
1.6 percentage of participants
|
2.9 percentage of participants
|
0.8 percentage of participants
|
1.5 percentage of participants
|
1.8 percentage of participants
|
|
Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 3
Fever >40 degree C (n = 128,136,126,135,166)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.8 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Within 4 days after toddler dosePopulation: Safety analysis set toddler dose: participants who receive toddler dose of 13vPnC or INFANRIX hexa and had AE or temperature data available. 'N' (number of participants analyzed) =participants reported yes for \>=1 day or no for all days, 'n' =participants reporting yes for \>=1 day or no for all days for specified event for each arm, respectively.
Participants' rectal temperature was collected for 4 days after each vaccination using an electronic diary. Participants' temperature was collected at 6 to 8 hours after vaccination, 6 to 8 hours following that and coincidentally with antipyretic administration for groups receiving antipyretics. Temperature was recorded at bedtime daily for 3 following days (Day 2 to Day 4) and at any time during the 3 days when fever was suspected. The highest temperature for each day was recorded in the e-diary. Incidences of fever were presented in following categories: \>=38 but \<=39 degree C, \>39 but \<=40 degree C and \>40 degree C.
Outcome measures
| Measure |
13vPnC + INFANRIX Hexa + Paracetamol Twice Daily
n=133 Participants
Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (greater than or equal to \[\>=\]56 to less than or equal to \[\<=\]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
|
13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily
n=140 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
|
13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily
n=134 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
|
13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily
n=144 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
|
13vPnC + INFANRIX Hexa
n=162 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
|
|---|---|---|---|---|---|
|
Percentage of Participants Reporting Fever Within 4 Days: Toddler Dose
Fever >40 degree C (n = 123,125,117,122,150)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants Reporting Fever Within 4 Days: Toddler Dose
Fever >=38, <=39 degree C (n= 133,140,134,144,162)
|
31.6 percentage of participants
|
37.1 percentage of participants
|
37.3 percentage of participants
|
50.0 percentage of participants
|
30.2 percentage of participants
|
|
Percentage of Participants Reporting Fever Within 4 Days: Toddler Dose
Fever >39, <=40 degree C (n = 128,127,118,123,150)
|
5.5 percentage of participants
|
7.1 percentage of participants
|
4.2 percentage of participants
|
5.7 percentage of participants
|
2.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to 1 Month (28 to 42 days) after infant seriesPopulation: Safety analysis set Dose 1 included all participants who receive Dose 1 of 13vPnC or INFANRIX hexa in infant series and had AE or temperature data available.
An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent events for infant series were events between infant series Dose 1 and up to 1 month (28 to 42 days) after infant series that were absent before treatment or that worsened relative to pre-treatment state. Reported non-SAEs included AEs other than SAEs collected using electronic diary (fever, systematic assessment) and events spontaneously collected on case report form at each visit (non-systematic assessment).
Outcome measures
| Measure |
13vPnC + INFANRIX Hexa + Paracetamol Twice Daily
n=173 Participants
Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (greater than or equal to \[\>=\]56 to less than or equal to \[\<=\]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
|
13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily
n=176 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
|
13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily
n=172 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
|
13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily
n=177 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
|
13vPnC + INFANRIX Hexa
n=210 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
|
|---|---|---|---|---|---|
|
Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs): Infant Series
Non-SAEs
|
57 participants
|
71 participants
|
67 participants
|
72 participants
|
80 participants
|
|
Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs): Infant Series
SAEs
|
7 participants
|
3 participants
|
11 participants
|
8 participants
|
10 participants
|
SECONDARY outcome
Timeframe: 1 Month (28 to 42 days) after infant series Dose 3 up to toddler dosePopulation: Safety analysis set Dose 3 included all participants who receive Dose 3 of 13vPnC or INFANRIX hexa in infant series and had AE or temperature data available.
An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent events after the infant series were events between 1 month (28 to 42 days) after infant series to toddler dose that were absent before treatment or that worsened relative to pre-treatment state. Reported non-SAEs included AEs other than SAEs spontaneously collected on case report form (non-systematic assessment).
Outcome measures
| Measure |
13vPnC + INFANRIX Hexa + Paracetamol Twice Daily
n=170 Participants
Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (greater than or equal to \[\>=\]56 to less than or equal to \[\<=\]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
|
13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily
n=174 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
|
13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily
n=172 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
|
13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily
n=176 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
|
13vPnC + INFANRIX Hexa
n=210 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
|
|---|---|---|---|---|---|
|
Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs): After the Infant Series
Non-SAEs
|
3 participants
|
6 participants
|
3 participants
|
4 participants
|
8 participants
|
|
Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs): After the Infant Series
SAEs
|
6 participants
|
14 participants
|
10 participants
|
11 participants
|
9 participants
|
SECONDARY outcome
Timeframe: Toddler dose up to 1 Month (28 to 42 days) after toddler dosePopulation: Safety analysis set toddler dose included all participants who receive toddler dose of 13vPnC or INFANRIX hexa and had AE or temperature data available.
An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent events for toddler dose were events between toddler dose and up to 1 month (28 to 42 days) after toddler dose that were absent before treatment or that worsened relative to pre-treatment state. Reported non-SAEs included AEs other than SAEs collected using electronic diary (fever, systematic assessment) and events spontaneously collected on case report form at each visit (non-systematic assessment).
Outcome measures
| Measure |
13vPnC + INFANRIX Hexa + Paracetamol Twice Daily
n=169 Participants
Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (greater than or equal to \[\>=\]56 to less than or equal to \[\<=\]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
|
13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily
n=173 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
|
13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily
n=170 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
|
13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily
n=175 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
|
13vPnC + INFANRIX Hexa
n=209 Participants
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
|
|---|---|---|---|---|---|
|
Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs): Toddler Dose
Non-SAEs
|
47 participants
|
57 participants
|
52 participants
|
76 participants
|
50 participants
|
|
Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs): Toddler Dose
SAEs
|
3 participants
|
2 participants
|
1 participants
|
1 participants
|
1 participants
|
Adverse Events
13vPnC+ INFANRIX Hexa +Paracetamol Twice Daily -Infant Series
Serious events: 7 serious events
Other events: 57 other events
Deaths: 0 deaths
13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily -Infant Series
Serious events: 3 serious events
Other events: 71 other events
Deaths: 0 deaths
13vPnC+INFANRIX Hexa+Paracetamol Thrice Daily -Infant Series
Serious events: 11 serious events
Other events: 67 other events
Deaths: 0 deaths
13vPnC+ INFANRIX Hexa+ Ibuprofen Thrice Daily -Infant Series
Serious events: 8 serious events
Other events: 72 other events
Deaths: 0 deaths
13vPnC + INFANRIX Hexa - Infant Series
Serious events: 10 serious events
Other events: 80 other events
Deaths: 0 deaths
13vPnC +INFANRIX Hexa +Paracetamol Twice Daily -After Inf Ser
Serious events: 6 serious events
Other events: 3 other events
Deaths: 0 deaths
13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily -After Inf Ser
Serious events: 14 serious events
Other events: 6 other events
Deaths: 0 deaths
13vPnC+INFANRIX Hexa +Paracetamol Thrice Daily -After Inf Ser
Serious events: 10 serious events
Other events: 3 other events
Deaths: 0 deaths
13vPnC +INFANRIX Hexa +Ibuprofen Thrice Daily -After Inf Ser
Serious events: 11 serious events
Other events: 4 other events
Deaths: 0 deaths
13vPnC + INFANRIX Hexa - After Infant Series
Serious events: 9 serious events
Other events: 8 other events
Deaths: 0 deaths
13vPnC +INFANRIX Hexa + Paracetamol Twice Daily -Toddler Dose
Serious events: 3 serious events
Other events: 47 other events
Deaths: 0 deaths
13vPnC +INFANRIX Hexa + Ibuprofen Twice Daily -Toddler Dose
Serious events: 2 serious events
Other events: 57 other events
Deaths: 0 deaths
13vPnC +INFANRIX Hexa +Paracetamol Thrice Daily -Toddler Dose
Serious events: 1 serious events
Other events: 52 other events
Deaths: 0 deaths
13vPnC +INFANRIX Hexa +Ibuprofen Thrice Daily -Toddler Dose
Serious events: 1 serious events
Other events: 76 other events
Deaths: 0 deaths
13vPnC + INFANRIX Hexa - Toddler Dose
Serious events: 1 serious events
Other events: 50 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
13vPnC+ INFANRIX Hexa +Paracetamol Twice Daily -Infant Series
n=173 participants at risk
Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions 28 to 42 days apart in infant series, along with paracetamol suspension 15 mg/kg orally at 6 to 8 hours after vaccination and 6 to 8 hours after first dose of paracetamol, assessed from Infant series Dose 1 through the blood draw 28 to 42 days post infant series.
|
13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily -Infant Series
n=176 participants at risk
Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions 28 to 42 days apart, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after vaccination and 6 to 8 hours after first dose of ibuprofen, assessed from Infant series Dose 1 through the blood draw 28 to 42 days post infant series.
|
13vPnC+INFANRIX Hexa+Paracetamol Thrice Daily -Infant Series
n=172 participants at risk
Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions 28 to 42 days apart, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol, assessed from Infant series Dose 1 through the blood draw 28 to 42 days post infant series.
|
13vPnC+ INFANRIX Hexa+ Ibuprofen Thrice Daily -Infant Series
n=177 participants at risk
Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions 28 to 42 days apart, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen, assessed from Infant series Dose 1 through the blood draw 28 to 42 days post infant series.
|
13vPnC + INFANRIX Hexa - Infant Series
n=210 participants at risk
Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions 28 to 42 days apart, assessed from Infant series Dose 1 through the blood draw 28 to 42 days post infant series (Inf Ser).
|
13vPnC +INFANRIX Hexa +Paracetamol Twice Daily -After Inf Ser
n=170 participants at risk
Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions 28 to 42 days apart in infant series (Inf Ser), along with paracetamol suspension 15 mg/kg orally at 6 to 8 hours after vaccination and 6 to 8 hours after first dose of paracetamol, assessed after the infant series blood draw up to toddler dose.
|
13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily -After Inf Ser
n=174 participants at risk
Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions 28 to 42 days apart in infant series (Inf Ser), along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after vaccination and 6 to 8 hours after first dose of ibuprofen, assessed after the infant series blood draw up to toddler dose.
|
13vPnC+INFANRIX Hexa +Paracetamol Thrice Daily -After Inf Ser
n=172 participants at risk
Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions 28 to 42 days apart in infant series (Inf Ser), along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol, assessed after the infant series blood draw up to toddler dose.
|
13vPnC +INFANRIX Hexa +Ibuprofen Thrice Daily -After Inf Ser
n=176 participants at risk
Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions 28 to 42 days apart in infant series (Inf Ser), along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen, assessed after the infant series blood draw up to toddler dose.
|
13vPnC + INFANRIX Hexa - After Infant Series
n=210 participants at risk
Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions 28 to 42 days apart in infant series, assessed after the infant series blood draw up to toddler dose.
|
13vPnC +INFANRIX Hexa + Paracetamol Twice Daily -Toddler Dose
n=169 participants at risk
Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions 28 to 42 days apart in infant series and toddler dose (0.5 mL) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 366 to 425 days of age, along with paracetamol suspension 15 mg/kg orally at 6 to 8 hours after vaccination and 6 to 8 hours after first dose of paracetamol, assessed from the toddler dose through the blood draw 28 to 42 days post toddler dose.
|
13vPnC +INFANRIX Hexa + Ibuprofen Twice Daily -Toddler Dose
n=173 participants at risk
Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions 28 to 42 days apart in infant series and toddler dose (0.5 mL) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 366 to 425 days of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after vaccination and 6 to 8 hours after first dose of ibuprofen, assessed from the toddler dose through the blood draw 28 to 42 days post toddler dose.
|
13vPnC +INFANRIX Hexa +Paracetamol Thrice Daily -Toddler Dose
n=170 participants at risk
Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions 28 to 42 days apart in infant series and toddler dose (0.5 mL) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 366 to 425 days of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol, assessed from the toddler dose through the blood draw 28 to 42 days post toddler dose.
|
13vPnC +INFANRIX Hexa +Ibuprofen Thrice Daily -Toddler Dose
n=175 participants at risk
Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions 28 to 42 days apart in infant series and toddler dose (0.5 mL) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 366 to 425 days of age, along with ibuprofen suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen, assessed from the toddler dose through the blood draw 28 to 42 days post toddler dose.
|
13vPnC + INFANRIX Hexa - Toddler Dose
n=209 participants at risk
Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions 28 to 42 days apart in infant series and toddler dose (0.5 mL) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 366 to 425 days of age, assessed from the toddler dose through the blood draw 28 to 42 days post toddler dose.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.58%
1/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.57%
1/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.48%
1/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.57%
1/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.58%
1/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
1.1%
2/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
1.4%
3/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Gastrointestinal disorders
Diarrhoea haemorrhagic
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.48%
1/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.57%
1/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.58%
1/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Gastrointestinal disorders
Stomatitis
|
0.58%
1/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.58%
1/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.58%
1/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.48%
1/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.58%
1/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.57%
1/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.48%
1/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Bronchitis
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.58%
1/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
1.1%
2/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.57%
1/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
1.1%
2/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Bronchopneumonia
|
1.2%
2/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.48%
1/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Exanthema subitum
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.58%
1/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.59%
1/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.58%
1/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.56%
1/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.48%
1/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
1.2%
2/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
2.3%
4/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.57%
1/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.59%
1/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Laryngitis
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.58%
1/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.58%
1/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.48%
1/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.56%
1/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.56%
1/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Otitis media
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.48%
1/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.57%
1/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Otitis media acute
|
0.58%
1/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.57%
1/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Pertussis
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.48%
1/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Pneumonia
|
1.2%
2/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
1.7%
3/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
1.1%
2/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.95%
2/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.59%
1/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.57%
1/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
1.2%
2/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
1.1%
2/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.48%
1/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.58%
1/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
1.1%
2/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.57%
1/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.58%
1/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Urinary tract infection
|
0.58%
1/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
1.1%
2/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.58%
1/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
1.1%
2/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.58%
1/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
1.1%
2/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.48%
1/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
1.2%
2/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Congenital, familial and genetic disorders
Ventricular septal defect
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.48%
1/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.57%
1/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.58%
1/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.57%
1/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Ear infection
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.57%
1/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Gastroenteritis Escherichia coli
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.58%
1/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Gastroenteritis rotavirus
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
1.7%
3/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.58%
1/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.48%
1/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.59%
1/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.48%
1/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Injury, poisoning and procedural complications
Exposure to toxic agent
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.58%
1/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.57%
1/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Nervous system disorders
Movement disorder
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.59%
1/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.57%
1/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.48%
1/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.59%
1/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.58%
1/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.57%
1/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Viral infection
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.59%
1/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Psychiatric disorders
Breath holding
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.48%
1/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
Other adverse events
| Measure |
13vPnC+ INFANRIX Hexa +Paracetamol Twice Daily -Infant Series
n=173 participants at risk
Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions 28 to 42 days apart in infant series, along with paracetamol suspension 15 mg/kg orally at 6 to 8 hours after vaccination and 6 to 8 hours after first dose of paracetamol, assessed from Infant series Dose 1 through the blood draw 28 to 42 days post infant series.
|
13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily -Infant Series
n=176 participants at risk
Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions 28 to 42 days apart, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after vaccination and 6 to 8 hours after first dose of ibuprofen, assessed from Infant series Dose 1 through the blood draw 28 to 42 days post infant series.
|
13vPnC+INFANRIX Hexa+Paracetamol Thrice Daily -Infant Series
n=172 participants at risk
Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions 28 to 42 days apart, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol, assessed from Infant series Dose 1 through the blood draw 28 to 42 days post infant series.
|
13vPnC+ INFANRIX Hexa+ Ibuprofen Thrice Daily -Infant Series
n=177 participants at risk
Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions 28 to 42 days apart, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen, assessed from Infant series Dose 1 through the blood draw 28 to 42 days post infant series.
|
13vPnC + INFANRIX Hexa - Infant Series
n=210 participants at risk
Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions 28 to 42 days apart, assessed from Infant series Dose 1 through the blood draw 28 to 42 days post infant series (Inf Ser).
|
13vPnC +INFANRIX Hexa +Paracetamol Twice Daily -After Inf Ser
n=170 participants at risk
Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions 28 to 42 days apart in infant series (Inf Ser), along with paracetamol suspension 15 mg/kg orally at 6 to 8 hours after vaccination and 6 to 8 hours after first dose of paracetamol, assessed after the infant series blood draw up to toddler dose.
|
13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily -After Inf Ser
n=174 participants at risk
Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions 28 to 42 days apart in infant series (Inf Ser), along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after vaccination and 6 to 8 hours after first dose of ibuprofen, assessed after the infant series blood draw up to toddler dose.
|
13vPnC+INFANRIX Hexa +Paracetamol Thrice Daily -After Inf Ser
n=172 participants at risk
Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions 28 to 42 days apart in infant series (Inf Ser), along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol, assessed after the infant series blood draw up to toddler dose.
|
13vPnC +INFANRIX Hexa +Ibuprofen Thrice Daily -After Inf Ser
n=176 participants at risk
Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions 28 to 42 days apart in infant series (Inf Ser), along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen, assessed after the infant series blood draw up to toddler dose.
|
13vPnC + INFANRIX Hexa - After Infant Series
n=210 participants at risk
Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions 28 to 42 days apart in infant series, assessed after the infant series blood draw up to toddler dose.
|
13vPnC +INFANRIX Hexa + Paracetamol Twice Daily -Toddler Dose
n=169 participants at risk
Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions 28 to 42 days apart in infant series and toddler dose (0.5 mL) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 366 to 425 days of age, along with paracetamol suspension 15 mg/kg orally at 6 to 8 hours after vaccination and 6 to 8 hours after first dose of paracetamol, assessed from the toddler dose through the blood draw 28 to 42 days post toddler dose.
|
13vPnC +INFANRIX Hexa + Ibuprofen Twice Daily -Toddler Dose
n=173 participants at risk
Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions 28 to 42 days apart in infant series and toddler dose (0.5 mL) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 366 to 425 days of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after vaccination and 6 to 8 hours after first dose of ibuprofen, assessed from the toddler dose through the blood draw 28 to 42 days post toddler dose.
|
13vPnC +INFANRIX Hexa +Paracetamol Thrice Daily -Toddler Dose
n=170 participants at risk
Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions 28 to 42 days apart in infant series and toddler dose (0.5 mL) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 366 to 425 days of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol, assessed from the toddler dose through the blood draw 28 to 42 days post toddler dose.
|
13vPnC +INFANRIX Hexa +Ibuprofen Thrice Daily -Toddler Dose
n=175 participants at risk
Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions 28 to 42 days apart in infant series and toddler dose (0.5 mL) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 366 to 425 days of age, along with ibuprofen suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen, assessed from the toddler dose through the blood draw 28 to 42 days post toddler dose.
|
13vPnC + INFANRIX Hexa - Toddler Dose
n=209 participants at risk
Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions 28 to 42 days apart in infant series and toddler dose (0.5 mL) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 366 to 425 days of age, assessed from the toddler dose through the blood draw 28 to 42 days post toddler dose.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.57%
1/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.58%
1/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.48%
1/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
1.2%
2/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.58%
1/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Congenital, familial and genetic disorders
Atrial septal defect
|
0.58%
1/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.58%
1/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.56%
1/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Congenital, familial and genetic disorders
Patent ductus arteriosus
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.58%
1/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.56%
1/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Eye disorders
Conjunctivitis
|
0.58%
1/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
1.7%
3/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
4.1%
7/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
2.8%
5/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.59%
1/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.48%
1/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Eye disorders
Dacryostenosis acquired
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.58%
1/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.56%
1/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.48%
1/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.57%
1/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.56%
1/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.48%
1/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
1.7%
3/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.56%
1/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.95%
2/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.58%
1/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.58%
1/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
1.1%
2/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
2.9%
5/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
2.3%
4/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.95%
2/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
1.8%
3/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.58%
1/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.59%
1/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
2.9%
5/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.96%
2/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Gastrointestinal disorders
Dyschezia
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.56%
1/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.56%
1/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.57%
1/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.58%
1/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.58%
1/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.48%
1/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.48%
1/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.48%
1/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Gastrointestinal disorders
Intestinal haemorrhage
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.57%
1/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Gastrointestinal disorders
Teething
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
1.1%
2/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.48%
1/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.48%
1/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
General disorders
Adverse drug reaction
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.56%
1/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
General disorders
Crying
|
0.58%
1/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.48%
1/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
General disorders
Irritability
|
0.58%
1/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
General disorders
Pyrexia
|
1.2%
2/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
3.4%
6/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
2.9%
5/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
1.1%
2/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.95%
2/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.57%
1/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.59%
1/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
1.7%
3/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.59%
1/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
1.7%
3/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.96%
2/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
General disorders
Vaccination site nodule
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.57%
1/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Immune system disorders
Milk allergy
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.57%
1/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.48%
1/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Anal abscess
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.48%
1/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Bronchitis
|
5.2%
9/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
4.5%
8/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
6.4%
11/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
5.1%
9/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
2.4%
5/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.48%
1/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
1.2%
2/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
1.8%
3/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
2.9%
5/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.96%
2/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.48%
1/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Candidiasis
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.57%
1/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Conjunctivitis infective
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.56%
1/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Cystitis
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.57%
1/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Ear infection
|
0.58%
1/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.59%
1/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Exanthema subitum
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
2.3%
4/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.58%
1/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.95%
2/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
1.2%
2/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.58%
1/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
2.4%
4/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.48%
1/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.57%
1/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.59%
1/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.57%
1/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.48%
1/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Impetigo
|
0.58%
1/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.48%
1/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Laryngitis
|
0.58%
1/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
1.1%
2/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
1.7%
3/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.56%
1/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.96%
2/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.57%
1/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.56%
1/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Nasopharyngitis
|
6.4%
11/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
3.4%
6/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
5.8%
10/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
4.5%
8/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
8.6%
18/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.48%
1/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.59%
1/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
1.2%
2/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
2.4%
4/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
1.1%
2/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.48%
1/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
1.2%
2/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.56%
1/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.48%
1/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Otitis media
|
0.58%
1/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.57%
1/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.95%
2/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.57%
1/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.58%
1/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.57%
1/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.56%
1/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.59%
1/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Pharyngitis
|
2.3%
4/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
3.4%
6/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
2.9%
5/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
2.3%
4/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
1.4%
3/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.59%
1/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
1.2%
2/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
2.9%
5/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.56%
1/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.95%
2/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Respiratory tract infection
|
2.3%
4/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
4.0%
7/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
2.3%
4/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
2.8%
5/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
1.4%
3/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.58%
1/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
3.4%
6/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.96%
2/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Rhinitis
|
1.7%
3/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
4.0%
7/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
6.4%
11/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
5.6%
10/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
4.3%
9/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.58%
1/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
1.2%
2/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
2.3%
4/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
2.9%
5/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
1.7%
3/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
2.4%
5/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Upper respiratory tract infection
|
8.7%
15/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
6.8%
12/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
8.1%
14/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
9.6%
17/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
5.7%
12/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
4.1%
7/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
4.0%
7/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
1.8%
3/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
2.3%
4/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
3.3%
7/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.57%
1/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
1.7%
3/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Varicella
|
0.58%
1/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
1.1%
2/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
1.7%
3/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.48%
1/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.59%
1/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.57%
1/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Viral upper respiratory tract infection
|
1.2%
2/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.57%
1/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.48%
1/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.57%
1/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.48%
1/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.58%
1/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Injury, poisoning and procedural complications
Mouth injury
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.57%
1/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Investigations
Cardiac murmur
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
1.1%
2/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
1.7%
3/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.56%
1/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.48%
1/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.48%
1/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.59%
1/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
1.7%
3/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Metabolism and nutrition disorders
Calcium metabolism disorder
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.56%
1/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Metabolism and nutrition disorders
Weight gain poor
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.57%
1/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.56%
1/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Nervous system disorders
Hypertonia
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.48%
1/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Nervous system disorders
Hypotonia
|
0.58%
1/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.58%
1/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.56%
1/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.48%
1/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Nervous system disorders
Neuromyopathy
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.58%
1/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.56%
1/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.48%
1/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Psychiatric disorders
Apathy
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.56%
1/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Renal and urinary disorders
Hypercalciuria
|
0.58%
1/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.57%
1/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Reproductive system and breast disorders
Genital labial adhesions
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.48%
1/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.58%
1/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.56%
1/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.58%
1/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Cafe au lait spots
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.48%
1/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.59%
1/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.57%
1/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
1.7%
3/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.57%
1/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.58%
1/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.56%
1/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.57%
1/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.48%
1/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
1.2%
2/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
1.2%
2/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
1.1%
2/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.58%
1/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.56%
1/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
1.9%
4/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.59%
1/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
1.2%
2/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.56%
1/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.57%
1/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.58%
1/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.56%
1/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.59%
1/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.57%
1/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.57%
1/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.56%
1/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.48%
1/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.59%
1/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.57%
1/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.58%
1/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
1.1%
2/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.58%
1/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.56%
1/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.48%
1/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Skin depigmentation
|
0.58%
1/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.57%
1/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.48%
1/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Congenital, familial and genetic disorders
Keratosis follicular
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.48%
1/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.59%
1/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.57%
1/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Immune system disorders
Food allergy
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.57%
1/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.57%
1/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Psychiatric disorders
Psychomotor retardation
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.57%
1/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Renal and urinary disorders
Vesicoureteric reflux
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.58%
1/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Reproductive system and breast disorders
Breast enlargement
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.57%
1/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.48%
1/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.48%
1/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.59%
1/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
1.8%
3/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.48%
1/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.59%
1/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
General disorders
Vaccination site swelling
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.48%
1/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Coxsackie viral infection
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.59%
1/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.59%
1/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.59%
1/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.48%
1/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Viral infection
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.59%
1/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.59%
1/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.48%
1/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.59%
1/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.48%
1/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Investigations
Weight increased
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.58%
1/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.57%
1/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
1.1%
2/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.48%
1/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/177 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/174 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/172 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/176 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/210 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/169 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/173 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/170 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.48%
1/209 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
General disorders
Fever >=38, <=39 degree C
|
22.1%
30/136 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
30.8%
45/146 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
17.0%
23/135 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
33.3%
47/141 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
29.7%
52/175 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and 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 pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and 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 pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and 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 pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and 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 pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and 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 pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and 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 pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and 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 pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and 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 pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and 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 pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and 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 pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
General disorders
Fever >39, <=40 degree C
|
1.6%
2/129 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
2.9%
4/137 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.80%
1/125 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
1.5%
2/136 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
1.8%
3/167 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and 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 pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and 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 pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and 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 pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and 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 pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and 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 pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and 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 pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and 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 pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and 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 pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and 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 pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and 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 pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
General disorders
Fever >40 degree C
|
0.00%
0/128 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/136 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.79%
1/126 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/135 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/166 • AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and 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 pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and 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 pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and 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 pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and 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 pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and 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 pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and 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 pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and 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 pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and 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 pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and 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 pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and 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 pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and 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