Trial Outcomes & Findings for Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants in India (NCT NCT00452790)
NCT ID: NCT00452790
Last Updated: 2011-03-24
Results Overview
Percentage of participants achieving a predefined antibody level of greater than or equal to 0.35 mcg/mL along with the corresponding O'Brien-Fleming-adjusted, exact, 2-sided 95% confidence interval (CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F and 19 A) are presented.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
708 participants
Primary outcome timeframe
1 month after the infant series (18 weeks of age)
Results posted on
2011-03-24
Participant Flow
708 participants were enrolled and 709 were randomized into the study. One infant in the 13vPnC group was randomly assigned twice because of technical difficulties with the first random assignment. Though this infant participated in the study only once, both random assignments were included in the 354 participants in the 13vPnC group.
Participant milestones
| Measure |
13vPnC
Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
|
7vPnC
Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
|
|---|---|---|
|
Infant Series
STARTED
|
354
|
355
|
|
Infant Series
Vaccinated Dose 1
|
353
|
353
|
|
Infant Series
Vaccinated Dose 2
|
300
|
300
|
|
Infant Series
Vaccinated Dose 3
|
221
|
218
|
|
Infant Series
COMPLETED
|
219
|
214
|
|
Infant Series
NOT COMPLETED
|
135
|
141
|
|
After Infant Series
STARTED
|
219
|
214
|
|
After Infant Series
COMPLETED
|
198
|
200
|
|
After Infant Series
NOT COMPLETED
|
21
|
14
|
|
Toddler Dose
STARTED
|
198
|
200
|
|
Toddler Dose
COMPLETED
|
198
|
198
|
|
Toddler Dose
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
13vPnC
Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
|
7vPnC
Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
|
|---|---|---|
|
Infant Series
Clinical hold - consent withdrawn
|
118
|
123
|
|
Infant Series
Parent/legal guardian request
|
8
|
6
|
|
Infant Series
Failed to return
|
4
|
1
|
|
Infant Series
Protocol Violation
|
1
|
3
|
|
Infant Series
Lost to Follow-up
|
2
|
2
|
|
Infant Series
Adverse Event
|
1
|
2
|
|
Infant Series
Other reasons
|
1
|
2
|
|
Infant Series
Investigator request
|
0
|
1
|
|
Infant Series
Death
|
0
|
1
|
|
After Infant Series
Investigator request
|
10
|
10
|
|
After Infant Series
Adverse Event
|
4
|
1
|
|
After Infant Series
Parent/legal guardian request
|
1
|
3
|
|
After Infant Series
Lost to Follow-up
|
4
|
0
|
|
After Infant Series
Failed to return
|
1
|
0
|
|
After Infant Series
Other reasons
|
1
|
0
|
|
Toddler Dose
Failed to return
|
0
|
1
|
|
Toddler Dose
Parent/legal guardian request
|
0
|
1
|
Baseline Characteristics
Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants in India
Baseline characteristics by cohort
| Measure |
13vPnC
n=354 Participants
Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
|
7vPnC
n=355 Participants
Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
|
Total
n=709 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
7.1 weeks
STANDARD_DEVIATION 1.1 • n=5 Participants
|
7.2 weeks
STANDARD_DEVIATION 1.1 • n=7 Participants
|
7.1 weeks
STANDARD_DEVIATION 1.1 • n=5 Participants
|
|
Sex/Gender, Customized
Male
|
184 participants
n=5 Participants
|
186 participants
n=7 Participants
|
370 participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
169 participants
n=5 Participants
|
169 participants
n=7 Participants
|
338 participants
n=5 Participants
|
|
Sex/Gender, Customized
Unknown
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 month after the infant series (18 weeks of age)Population: Evaluable immunogenicity population: had treatments as randomized at all 3 doses, blood drawn within specified timeframes, had at least 1 valid and determinate assay result for the proposed analysis, and no major protocol violations. n=number of participants with determinate IgG antibody concentration for the specified serotype.
Percentage of participants achieving a predefined antibody level of greater than or equal to 0.35 mcg/mL along with the corresponding O'Brien-Fleming-adjusted, exact, 2-sided 95% confidence interval (CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F and 19 A) are presented.
Outcome measures
| Measure |
13vPnC
n=206 Participants
Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
|
7vPnC
n=196 Participants
Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
|
|---|---|---|
|
Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Micrograms (Mcg)/mL, 1 Month After the Infant Series.
Common serotypes - serotype 14 (n= 185,186)
|
91.4 Percentage of participants
Interval 86.3 to 95.0
|
93.5 Percentage of participants
Interval 89.0 to 96.6
|
|
Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Micrograms (Mcg)/mL, 1 Month After the Infant Series.
Common serotypes - serotype 18C (n= 204,188)
|
95.1 Percentage of participants
Interval 91.1 to 97.6
|
93.1 Percentage of participants
Interval 88.4 to 96.3
|
|
Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Micrograms (Mcg)/mL, 1 Month After the Infant Series.
Common serotypes - serotype 4 (n= 203, 192)
|
97.0 Percentage of participants
Interval 93.6 to 98.9
|
97.9 Percentage of participants
Interval 94.7 to 99.4
|
|
Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Micrograms (Mcg)/mL, 1 Month After the Infant Series.
Common serotypes - serotype 6B (n= 196,194)
|
84.7 Percentage of participants
Interval 78.8 to 89.5
|
87.1 Percentage of participants
Interval 81.5 to 91.5
|
|
Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Micrograms (Mcg)/mL, 1 Month After the Infant Series.
Common serotypes - serotype 9V (n= 204,195)
|
92.6 Percentage of participants
Interval 88.1 to 95.8
|
94.4 Percentage of participants
Interval 90.1 to 97.2
|
|
Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Micrograms (Mcg)/mL, 1 Month After the Infant Series.
Common serotypes - serotype 19F (n= 200,188)
|
95.0 Percentage of participants
Interval 91.0 to 97.6
|
94.7 Percentage of participants
Interval 90.4 to 97.4
|
|
Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Micrograms (Mcg)/mL, 1 Month After the Infant Series.
Common serotypes - serotype 23F (n= 202,186)
|
90.1 Percentage of participants
Interval 85.1 to 93.9
|
89.2 Percentage of participants
Interval 83.8 to 93.3
|
|
Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Micrograms (Mcg)/mL, 1 Month After the Infant Series.
Additional serotypes - serotype 1 (n= 206,195)
|
96.6 Percentage of participants
Interval 93.1 to 98.6
|
0.5 Percentage of participants
Interval 0.0 to 2.8
|
|
Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Micrograms (Mcg)/mL, 1 Month After the Infant Series.
Additional serotypes - serotype 3 (n= 201,187)
|
87.6 Percentage of participants
Interval 82.1 to 91.8
|
2.1 Percentage of participants
Interval 0.6 to 5.4
|
|
Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Micrograms (Mcg)/mL, 1 Month After the Infant Series.
Additional serotypes - serotype 5 (n= 201,185)
|
85.1 Percentage of participants
Interval 79.3 to 89.7
|
24.3 Percentage of participants
Interval 18.3 to 31.2
|
|
Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Micrograms (Mcg)/mL, 1 Month After the Infant Series.
Additional serotypes - serotype 6A (n= 200,191)
|
90.0 Percentage of participants
Interval 84.9 to 93.8
|
36.1 Percentage of participants
Interval 29.3 to 43.4
|
|
Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Micrograms (Mcg)/mL, 1 Month After the Infant Series.
Additional serotypes - serotype 7F (n= 203,192)
|
98.0 Percentage of participants
Interval 95.0 to 99.5
|
2.6 Percentage of participants
Interval 0.8 to 6.0
|
|
Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Micrograms (Mcg)/mL, 1 Month After the Infant Series.
Additional serotypes - serotype 19 A (n= 204,190)
|
99.5 Percentage of participants
Interval 97.3 to 100.0
|
84.7 Percentage of participants
Interval 78.8 to 89.6
|
PRIMARY outcome
Timeframe: 1 month after the infant series (18 weeks of age)Population: Evaluable immunogenicity population: had treatments as randomized at all 3 doses, blood drawn within specified timeframes, had at least 1 valid and determinate assay result for the proposed analysis, and no major protocol violations.
Percentage of participants achieving a predefined antibody level (measured in enzyme-linked immunosorbent assay \[ELISA\] units per mL \[EU/mL\]) along with the corresponding O'Brien-Fleming-adjusted, exact, 2-sided 95% CI for concomitant antigens pertussis (PT, FHA and PRN) are presented.
Outcome measures
| Measure |
13vPnC
n=206 Participants
Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
|
7vPnC
n=196 Participants
Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
|
|---|---|---|
|
Percentage of Participants Achieving a Predefined Antibody Level for Concomitant Vaccine Pertussis Antigens (Pertussis Toxoid [PT], Filamentous Hemagglutinin [FHA], Pertactin [PRN]), 1 Month After the Infant Series.
PT >=0.975 EU/mL
|
100.0 Percentage of participants
Interval 98.2 to 100.0
|
100.0 Percentage of participants
Interval 98.1 to 100.0
|
|
Percentage of Participants Achieving a Predefined Antibody Level for Concomitant Vaccine Pertussis Antigens (Pertussis Toxoid [PT], Filamentous Hemagglutinin [FHA], Pertactin [PRN]), 1 Month After the Infant Series.
FHA >=3.91 EU/mL
|
100.0 Percentage of participants
Interval 98.2 to 100.0
|
100.0 Percentage of participants
Interval 98.1 to 100.0
|
|
Percentage of Participants Achieving a Predefined Antibody Level for Concomitant Vaccine Pertussis Antigens (Pertussis Toxoid [PT], Filamentous Hemagglutinin [FHA], Pertactin [PRN]), 1 Month After the Infant Series.
PRN >=6 EU/mL
|
92.7 Percentage of participants
Interval 88.2 to 95.9
|
95.9 Percentage of participants
Interval 92.1 to 98.2
|
SECONDARY outcome
Timeframe: 1 month after the toddler dose (13 months of age)Population: Evaluable immunogenicity population: had treatments as randomized at all 4 doses, blood drawn within specified timeframes, had at least 1 valid and determinate assay result for the proposed analysis, and no major protocol violations. n=number of participants with determinate IgG antibody concentration for the specified serotype.
Percentage of participants achieving a predefined antibody level of greater than or equal to 0.35 mcg/mL along with the corresponding exact, 2-sided 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F and 19 A) are presented.
Outcome measures
| Measure |
13vPnC
n=193 Participants
Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
|
7vPnC
n=196 Participants
Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
|
|---|---|---|
|
Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Mcg/mL, 1 Month After the Toddler Dose.
Additional serotypes - serotype 3 (n= 193,196)
|
90.2 Percentage of participants
Interval 85.1 to 94.0
|
12.9 Percentage of participants
Interval 8.5 to 18.4
|
|
Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Mcg/mL, 1 Month After the Toddler Dose.
Additional serotypes - serotype 5 (n= 192,196)
|
100.0 Percentage of participants
Interval 98.1 to 100.0
|
74.3 Percentage of participants
Interval 67.4 to 80.5
|
|
Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Mcg/mL, 1 Month After the Toddler Dose.
Common serotypes - serotype 4 (n= 193, 196)
|
100.0 Percentage of participants
Interval 98.1 to 100.0
|
100.0 Percentage of participants
Interval 98.1 to 100.0
|
|
Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Mcg/mL, 1 Month After the Toddler Dose.
Common serotypes - serotype 6B (n= 192,195)
|
100.0 Percentage of participants
Interval 98.1 to 100.0
|
99.5 Percentage of participants
Interval 97.2 to 100.0
|
|
Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Mcg/mL, 1 Month After the Toddler Dose.
Common serotypes - serotype 9V (n= 193,196)
|
99.5 Percentage of participants
Interval 97.1 to 100.0
|
99.5 Percentage of participants
Interval 97.2 to 100.0
|
|
Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Mcg/mL, 1 Month After the Toddler Dose.
Common serotypes - serotype 14 (n= 193,196)
|
99.5 Percentage of participants
Interval 97.1 to 100.0
|
99.5 Percentage of participants
Interval 97.2 to 100.0
|
|
Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Mcg/mL, 1 Month After the Toddler Dose.
Common serotypes - serotype 18C (n= 193,196)
|
99.5 Percentage of participants
Interval 97.1 to 100.0
|
99.0 Percentage of participants
Interval 96.4 to 99.9
|
|
Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Mcg/mL, 1 Month After the Toddler Dose.
Common serotypes - serotype 19F (n= 193,196)
|
97.9 Percentage of participants
Interval 94.8 to 99.4
|
98.0 Percentage of participants
Interval 94.9 to 99.4
|
|
Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Mcg/mL, 1 Month After the Toddler Dose.
Common serotypes - serotype 23F (n= 193,196)
|
98.4 Percentage of participants
Interval 95.5 to 99.7
|
99.5 Percentage of participants
Interval 97.2 to 100.0
|
|
Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Mcg/mL, 1 Month After the Toddler Dose.
Additional serotypes - serotype 1 (n= 193,196)
|
98.4 Percentage of participants
Interval 95.5 to 99.7
|
3.1 Percentage of participants
Interval 1.1 to 6.6
|
|
Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Mcg/mL, 1 Month After the Toddler Dose.
Additional serotypes - serotype 6A (n= 193,196)
|
100.0 Percentage of participants
Interval 98.1 to 100.0
|
92.8 Percentage of participants
Interval 88.2 to 96.0
|
|
Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Mcg/mL, 1 Month After the Toddler Dose.
Additional serotypes - serotype 7F (n= 193,196)
|
99.0 Percentage of participants
Interval 96.3 to 99.9
|
9.8 Percentage of participants
Interval 6.0 to 14.9
|
|
Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Mcg/mL, 1 Month After the Toddler Dose.
Additional serotypes - serotype 19 A (n= 193,196)
|
100.0 Percentage of participants
Interval 98.1 to 100.0
|
98.5 Percentage of participants
Interval 95.5 to 99.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 month after the 3-dose infant series (18 weeks of age)Population: Evaluable immunogenicity population: had treatments as randomized at all 3 doses, blood drawn within specified timeframes, had at least 1 valid and determinate assay result for the proposed analysis, and no major protocol violations. n=number of participants with determinate IgG antibody concentration for the specified serotype.
Antibody GMC as measured in mcg/mL for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding O'Brien-Fleming-adjusted, 2-sided 95% CIs were calculated.
Outcome measures
| Measure |
13vPnC
n=206 Participants
Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
|
7vPnC
n=196 Participants
Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
|
|---|---|---|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the 3-Dose Infant Series
Common serotypes - serotype 4 (n= 203,192)
|
2.19 mcg/mL
Interval 1.95 to 2.46
|
2.58 mcg/mL
Interval 2.26 to 2.95
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the 3-Dose Infant Series
Common serotypes - serotype 6B (n= 196,194)
|
1.45 mcg/mL
Interval 1.2 to 1.75
|
1.56 mcg/mL
Interval 1.28 to 1.89
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the 3-Dose Infant Series
Common serotypes - serotype 9V (n= 204,195)
|
1.34 mcg/mL
Interval 1.19 to 1.5
|
1.46 mcg/mL
Interval 1.28 to 1.65
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the 3-Dose Infant Series
Common serotypes - serotype 14 (n= 185,186)
|
2.84 mcg/mL
Interval 2.35 to 3.43
|
2.39 mcg/mL
Interval 1.98 to 2.9
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the 3-Dose Infant Series
Common serotypes - serotype 18C (n= 204,188)
|
1.61 mcg/mL
Interval 1.42 to 1.82
|
1.70 mcg/mL
Interval 1.47 to 1.96
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the 3-Dose Infant Series
Common serotypes - serotype 19F (n= 200,188)
|
2.25 mcg/mL
Interval 1.97 to 2.56
|
2.47 mcg/mL
Interval 2.11 to 2.89
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the 3-Dose Infant Series
Common serotypes - serotype 23F (n= 202,186)
|
1.38 mcg/mL
Interval 1.18 to 1.6
|
1.46 mcg/mL
Interval 1.25 to 1.7
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the 3-Dose Infant Series
Additional serotypes - serotype 1 (n= 206,195)
|
1.95 mcg/mL
Interval 1.72 to 2.22
|
0.03 mcg/mL
Interval 0.03 to 0.04
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the 3-Dose Infant Series
Additional serotypes - serotype 3 (n= 201,195)
|
0.80 mcg/mL
Interval 0.72 to 0.9
|
0.05 mcg/mL
Interval 0.05 to 0.06
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the 3-Dose Infant Series
Additional serotypes - serotype 5 (n= 201,195)
|
0.93 mcg/mL
Interval 0.82 to 1.06
|
0.20 mcg/mL
Interval 0.18 to 0.23
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the 3-Dose Infant Series
Additional serotypes - serotype 6A (n= 200,195)
|
1.44 mcg/mL
Interval 1.25 to 1.66
|
0.28 mcg/mL
Interval 0.25 to 0.31
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the 3-Dose Infant Series
Additional serotypes - serotype 7F (n= 203,195)
|
2.27 mcg/mL
Interval 2.05 to 2.33
|
0.06 mcg/mL
Interval 0.05 to 0.06
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the 3-Dose Infant Series
Additional serotypes - serotype 19A (n= 204,195)
|
2.76 mcg/mL
Interval 2.46 to 3.1
|
0.74 mcg/mL
Interval 0.66 to 0.82
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 month after toddler dose (13 months of age)Population: Evaluable immunogenicity population: had treatments as randomized at all 4 doses, blood drawn within specified timeframes, had at least 1 valid and determinate assay result for the proposed analysis, and no major protocol violations. n=number of participants with determinate IgG antibody concentration for the specified serotype.
Antibody GMC as measured in mcg/mL for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were presented.
Outcome measures
| Measure |
13vPnC
n=193 Participants
Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
|
7vPnC
n=196 Participants
Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
|
|---|---|---|
|
GMC for Serotype-specific Pneumococcal IgG Antibody, 1 Month After the Toddler Dose
Common serotypes - serotype 4 (n= 193, 196)
|
5.33 mcg/mL
Interval 4.69 to 6.04
|
5.85 mcg/mL
Interval 5.13 to 6.68
|
|
GMC for Serotype-specific Pneumococcal IgG Antibody, 1 Month After the Toddler Dose
Common serotypes - serotype 6B (n= 192, 195)
|
12.24 mcg/mL
Interval 10.6 to 14.13
|
11.60 mcg/mL
Interval 9.95 to 13.53
|
|
GMC for Serotype-specific Pneumococcal IgG Antibody, 1 Month After the Toddler Dose
Common serotypes - serotype 9V (n= 193,196)
|
3.01 mcg/mL
Interval 2.68 to 3.37
|
3.33 mcg/mL
Interval 2.96 to 3.75
|
|
GMC for Serotype-specific Pneumococcal IgG Antibody, 1 Month After the Toddler Dose
Common serotypes - serotype 14 (n= 193,196)
|
10.59 mcg/mL
Interval 9.21 to 12.18
|
10.95 mcg/mL
Interval 9.41 to 12.74
|
|
GMC for Serotype-specific Pneumococcal IgG Antibody, 1 Month After the Toddler Dose
Common serotypes - serotype 18C (n= 193,196)
|
2.63 mcg/mL
Interval 2.33 to 2.97
|
2.98 mcg/mL
Interval 2.65 to 3.34
|
|
GMC for Serotype-specific Pneumococcal IgG Antibody, 1 Month After the Toddler Dose
Common serotypes - serotype 19F (n= 193,196)
|
8.38 mcg/mL
Interval 7.11 to 9.87
|
5.65 mcg/mL
Interval 4.84 to 6.58
|
|
GMC for Serotype-specific Pneumococcal IgG Antibody, 1 Month After the Toddler Dose
Common serotypes - serotype 23F (n= 193,196)
|
4.27 mcg/mL
Interval 3.66 to 4.98
|
5.31 mcg/mL
Interval 4.66 to 6.04
|
|
GMC for Serotype-specific Pneumococcal IgG Antibody, 1 Month After the Toddler Dose
Additional serotypes - serotype 1 (n= 193,196)
|
5.10 mcg/mL
Interval 4.39 to 5.92
|
0.04 mcg/mL
Interval 0.04 to 0.05
|
|
GMC for Serotype-specific Pneumococcal IgG Antibody, 1 Month After the Toddler Dose
Additional serotypes - serotype 3 (n= 193,196)
|
0.91 mcg/mL
Interval 0.81 to 1.03
|
0.09 mcg/mL
Interval 0.08 to 0.11
|
|
GMC for Serotype-specific Pneumococcal IgG Antibody, 1 Month After the Toddler Dose
Additional serotypes - serotype 5 (n= 192,196)
|
3.58 mcg/mL
Interval 3.2 to 4.0
|
0.64 mcg/mL
Interval 0.55 to 0.75
|
|
GMC for Serotype-specific Pneumococcal IgG Antibody, 1 Month After the Toddler Dose
Additional serotypes - serotype 6A (n= 193,196)
|
8.13 mcg/mL
Interval 7.11 to 9.28
|
1.87 mcg/mL
Interval 1.62 to 2.17
|
|
GMC for Serotype-specific Pneumococcal IgG Antibody, 1 Month After the Toddler Dose
Additional serotypes - serotype 7F (n= 193,196)
|
4.81 mcg/mL
Interval 4.27 to 5.42
|
0.06 mcg/mL
Interval 0.05 to 0.08
|
|
GMC for Serotype-specific Pneumococcal IgG Antibody, 1 Month After the Toddler Dose
Additional serotypes - serotype 19A (n= 193,196)
|
14.12 mcg/mL
Interval 12.45 to 16.01
|
3.56 mcg/mL
Interval 3.14 to 4.05
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Within 4 days after the dose 1 of the infant series (6 weeks of age)Population: Safety population: all participants who received dose 1 of the infant series vaccination (6 weeks of age). n= number of participants reporting yes for at least 1 day or no for all days for each treatment group respectively.
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 cm to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (\> 7.0 cm). Participants may be represented in more than 1 category.
Outcome measures
| Measure |
13vPnC
n=353 Participants
Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
|
7vPnC
n=353 Participants
Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
|
|---|---|---|
|
Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 1 (6 Weeks of Age)
Tenderness: Any (n= 347,347)
|
62.5 Percentage of participants
|
59.7 Percentage of participants
|
|
Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 1 (6 Weeks of Age)
Tenderness: Significant (n= 341,343)
|
42.2 Percentage of participants
|
40.5 Percentage of participants
|
|
Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 1 (6 Weeks of Age)
Induration: Any (n= 339,342)
|
21.5 Percentage of participants
|
22.5 Percentage of participants
|
|
Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 1 (6 Weeks of Age)
Induration: Mild (n= 338,340)
|
19.2 Percentage of participants
|
19.1 Percentage of participants
|
|
Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 1 (6 Weeks of Age)
Induration: Moderate (n= 331,338)
|
4.8 Percentage of participants
|
5.6 Percentage of participants
|
|
Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 1 (6 Weeks of Age)
Induration: Severe (n= 329,336)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 1 (6 Weeks of Age)
Erythema: Any (n= 333,339)
|
12.6 Percentage of participants
|
13.3 Percentage of participants
|
|
Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 1 (6 Weeks of Age)
Erythema: Mild (n= 333,338)
|
11.4 Percentage of participants
|
11.8 Percentage of participants
|
|
Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 1 (6 Weeks of Age)
Erythema: Moderate (n= 330,337)
|
1.5 Percentage of participants
|
1.8 Percentage of participants
|
|
Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 1 (6 Weeks of Age)
Erythema: Severe (n= 329,336)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 1 (6 Weeks of Age)
Any of the above (n= 349,348)
|
66.8 Percentage of participants
|
65.2 Percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Within 4 days after the dose 2 of the infant series (10 weeks of age)Population: Safety population: all participants who received the first 2 doses of the infant series vaccination (10 weeks of age).n= number of participants reporting yes for at least 1 day or no for all days for each treatment group respectively.
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 cm to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (\> 7.0 cm). Participants may be represented in more than 1 category.
Outcome measures
| Measure |
13vPnC
n=300 Participants
Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
|
7vPnC
n=300 Participants
Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
|
|---|---|---|
|
Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 2 (10 Weeks of Age)
Erythema: Mild (n= 275,279)
|
13.1 Percentage of participants
|
15.8 Percentage of participants
|
|
Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 2 (10 Weeks of Age)
Tenderness: Any (n= 284,282)
|
44.4 Percentage of participants
|
44.0 Percentage of participants
|
|
Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 2 (10 Weeks of Age)
Tenderness: Significant (n= 278,279)
|
26.6 Percentage of participants
|
28.0 Percentage of participants
|
|
Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 2 (10 Weeks of Age)
Induration: Any (n= 281,278)
|
20.6 Percentage of participants
|
18.7 Percentage of participants
|
|
Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 2 (10 Weeks of Age)
Induration: Mild (n= 281,277)
|
16.7 Percentage of participants
|
16.2 Percentage of participants
|
|
Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 2 (10 Weeks of Age)
Induration: Moderate (n= 273,272)
|
5.1 Percentage of participants
|
4.0 Percentage of participants
|
|
Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 2 (10 Weeks of Age)
Induration: Severe (n= 273,271)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 2 (10 Weeks of Age)
Erythema: Any (n= 275,280)
|
13.8 Percentage of participants
|
17.9 Percentage of participants
|
|
Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 2 (10 Weeks of Age)
Erythema: Moderate (n= 273,273)
|
1.5 Percentage of participants
|
2.9 Percentage of participants
|
|
Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 2 (10 Weeks of Age)
Erythema: Severe (n= 273,271)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 2 (10 Weeks of Age)
Any of the above (n= 285,286)
|
51.6 Percentage of participants
|
53.1 Percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Within 4 days after the dose 3 of the infant series (14 weeks of age)Population: Safety population: all participants who received all 3 doses of the infant series vaccination (14 weeks of age).n= number of participants reporting yes for at least 1 day or no for all days for each treatment group respectively.
Local reactions were reported using an electronic diary by the parent/legal guardian. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration and erythema present); Mild (0.5 cm to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (\> 7.0 cm). Participants may be represented in more than 1 category.
Outcome measures
| Measure |
13vPnC
n=221 Participants
Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
|
7vPnC
n=218 Participants
Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
|
|---|---|---|
|
Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 3 (14 Weeks of Age)
Tenderness: Any (n= 204,200)
|
37.3 Percentage of participants
|
38.0 Percentage of participants
|
|
Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 3 (14 Weeks of Age)
Tenderness: Significant (n= 199,196)
|
24.1 Percentage of participants
|
23.5 Percentage of participants
|
|
Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 3 (14 Weeks of Age)
Induration: Any (n= 198,195)
|
17.2 Percentage of participants
|
13.8 Percentage of participants
|
|
Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 3 (14 Weeks of Age)
Induration: Mild (n= 196,195)
|
15.8 Percentage of participants
|
11.8 Percentage of participants
|
|
Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 3 (14 Weeks of Age)
Induration: Moderate (n= 193,193)
|
2.6 Percentage of participants
|
3.6 Percentage of participants
|
|
Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 3 (14 Weeks of Age)
Induration: Severe (n= 191,193)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 3 (14 Weeks of Age)
Erythema: Any (n= 192,195)
|
10.4 Percentage of participants
|
9.7 Percentage of participants
|
|
Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 3 (14 Weeks of Age)
Erythema: Mild (n= 192,195)
|
10.4 Percentage of participants
|
9.2 Percentage of participants
|
|
Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 3 (14 Weeks of Age)
Erythema: Moderate (n= 191,193)
|
0.0 Percentage of participants
|
0.5 Percentage of participants
|
|
Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 3 (14 Weeks of Age)
Erythema: Severe (n= 191,193)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 3 (14 Weeks of Age)
Any of the above (n= 206,202)
|
43.2 Percentage of participants
|
42.1 Percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Within 4 days after the toddler dose (12 months of age)Population: Safety population: all participants who received toddler dose vaccination(after 12 months). n= number of participants reporting yes for at least 1 day or no for all days for each treatment group respectively.
Local reactions were reported using an electronic diary by the parent/legal guardian. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration and erythema present); Mild (0.5 cm to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (\> 7.0 cm). Participants may be represented in more than 1 category.
Outcome measures
| Measure |
13vPnC
n=198 Participants
Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
|
7vPnC
n=200 Participants
Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
|
|---|---|---|
|
Percentage of Participants With Pre-specified Local Reactions: Toddler Dose (12 Months of Age)
Induration: Severe (n= 167,169)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Pre-specified Local Reactions: Toddler Dose (12 Months of Age)
Erythema: Moderate (n= 169,170)
|
3.6 Percentage of participants
|
4.1 Percentage of participants
|
|
Percentage of Participants With Pre-specified Local Reactions: Toddler Dose (12 Months of Age)
Tenderness: Any (n= 174,176)
|
29.9 Percentage of participants
|
30.7 Percentage of participants
|
|
Percentage of Participants With Pre-specified Local Reactions: Toddler Dose (12 Months of Age)
Tenderness: Significant (n= 171,170)
|
15.8 Percentage of participants
|
17.1 Percentage of participants
|
|
Percentage of Participants With Pre-specified Local Reactions: Toddler Dose (12 Months of Age)
Induration: Any (n= 173,176)
|
19.7 Percentage of participants
|
17.6 Percentage of participants
|
|
Percentage of Participants With Pre-specified Local Reactions: Toddler Dose (12 Months of Age)
Induration: Mild (n= 170,175)
|
15.9 Percentage of participants
|
14.9 Percentage of participants
|
|
Percentage of Participants With Pre-specified Local Reactions: Toddler Dose (12 Months of Age)
Induration: Moderate (n= 170,171)
|
5.3 Percentage of participants
|
7.6 Percentage of participants
|
|
Percentage of Participants With Pre-specified Local Reactions: Toddler Dose (12 Months of Age)
Erythema: Any (n= 174,176)
|
14.9 Percentage of participants
|
14.2 Percentage of participants
|
|
Percentage of Participants With Pre-specified Local Reactions: Toddler Dose (12 Months of Age)
Erythema: Mild (n= 172,175)
|
12.2 Percentage of participants
|
10.9 Percentage of participants
|
|
Percentage of Participants With Pre-specified Local Reactions: Toddler Dose (12 Months of Age)
Erythema: Severe (n= 167,169)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Pre-specified Local Reactions: Toddler Dose (12 Months of Age)
Any of the above (n= 177,178)
|
36.7 Percentage of participants
|
41.0 Percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Within 4 days after the dose 1 of the infant series (6 weeks of age)Population: Safety population: all participants who received at least dose 1 of the infant series vaccination (after 6 weeks. n=number of participants reporting yes for at least 1 day or no for all days for each treatment group respectively.
Systemic events (any fever \>=38 degrees Celsius \[C\], decreased appetite, irritability, increased sleep, decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.
Outcome measures
| Measure |
13vPnC
n=353 Participants
Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
|
7vPnC
n=353 Participants
Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
|
|---|---|---|
|
Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 1 (6 Weeks of Age)
Fever >=38 but <=39 degrees C (n= 313,324)
|
19.8 Percentage of participants
|
21.6 Percentage of participants
|
|
Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 1 (6 Weeks of Age)
Fever >40 degrees C (n= 309,322)
|
0.3 Percentage of participants
|
0.9 Percentage of participants
|
|
Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 1 (6 Weeks of Age)
Decreased appetite (n= 343,347)
|
55.7 Percentage of participants
|
55.9 Percentage of participants
|
|
Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 1 (6 Weeks of Age)
Fever >39 but <=40 degrees C (n= 309,322)
|
2.3 Percentage of participants
|
1.2 Percentage of participants
|
|
Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 1 (6 Weeks of Age)
Irritability (n= 345,347)
|
83.2 Percentage of participants
|
79.8 Percentage of participants
|
|
Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 1 (6 Weeks of Age)
Increased sleep (n= 338,342)
|
40.8 Percentage of participants
|
36.8 Percentage of participants
|
|
Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 1 (6 Weeks of Age)
Decreased sleep (n= 336,343)
|
55.7 Percentage of participants
|
56.0 Percentage of participants
|
|
Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 1 (6 Weeks of Age)
Any systemic event (n= 350,348)
|
94.3 Percentage of participants
|
90.8 Percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Within 4 days after the dose 2 of the infant series (10 weeks of age)Population: Safety population: all participants who received dose 2 of the infant series vaccination (10 weeks of age); n= number of participants reporting yes for at least 1 day or no for all days for each treatment group respectively.
Systemic events (any fever \>=38 degrees Celsius \[C\], decreased appetite, irritability, increased sleep, decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.
Outcome measures
| Measure |
13vPnC
n=300 Participants
Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
|
7vPnC
n=300 Participants
Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
|
|---|---|---|
|
Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 2 (10 Weeks of Age)
Fever >=38 but <=39 degrees C (n= 263,249)
|
10.3 Percentage of participants
|
15.3 Percentage of participants
|
|
Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 2 (10 Weeks of Age)
Fever >39 but <=40 degrees C (n= 259,247)
|
0.8 Percentage of participants
|
0.4 Percentage of participants
|
|
Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 2 (10 Weeks of Age)
Fever >40 degrees C (n= 259,247)
|
0.0 Percentage of participants
|
0.4 Percentage of participants
|
|
Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 2 (10 Weeks of Age)
Decreased appetite (n= 281,282)
|
48.0 Percentage of participants
|
46.5 Percentage of participants
|
|
Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 2 (10 Weeks of Age)
Irritability (n= 290,291)
|
70.7 Percentage of participants
|
69.8 Percentage of participants
|
|
Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 2 (10 Weeks of Age)
Increased sleep (n= 285,275)
|
33.7 Percentage of participants
|
26.9 Percentage of participants
|
|
Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 2 (10 Weeks of Age)
Decreased sleep (n= 282,286)
|
37.9 Percentage of participants
|
46.9 Percentage of participants
|
|
Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 2 (10 Weeks of Age)
Any systemic event (n= 294,297)
|
80.6 Percentage of participants
|
80.5 Percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Within 4 days after the dose 3 of the infant series (14 weeks of age)Population: Safety population: all participants who received dose 3 of the infant series vaccination (14 weeks of age).n= number of participants reporting yes for at least 1 day or no for all days for each treatment group respectively.
Systemic events (any fever \>=38 degrees Celsius \[C\], decreased appetite, irritability, increased sleep, decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.
Outcome measures
| Measure |
13vPnC
n=221 Participants
Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
|
7vPnC
n=218 Participants
Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
|
|---|---|---|
|
Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 3 (14 Weeks of Age)
Fever >=38 but <=39 degrees C (n= 181,172)
|
7.7 Percentage of participants
|
14.0 Percentage of participants
|
|
Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 3 (14 Weeks of Age)
Fever >39 but <=40 degrees C (n= 179,170)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 3 (14 Weeks of Age)
Fever >40 degrees C (n= 179,171)
|
0.0 Percentage of participants
|
0.6 Percentage of participants
|
|
Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 3 (14 Weeks of Age)
Decreased appetite (n= 202,200)
|
42.1 Percentage of participants
|
41.0 Percentage of participants
|
|
Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 3 (14 Weeks of Age)
Irritability (n= 208,208)
|
64.4 Percentage of participants
|
67.3 Percentage of participants
|
|
Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 3 (14 Weeks of Age)
Increased sleep (n= 199,195)
|
20.1 Percentage of participants
|
20.5 Percentage of participants
|
|
Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 3 (14 Weeks of Age)
Decreased sleep (n= 205,201)
|
42.4 Percentage of participants
|
36.8 Percentage of participants
|
|
Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 3 (14 Weeks of Age)
Any systemic event (n= 213,209)
|
75.1 Percentage of participants
|
78.5 Percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Within 4 days after the toddler dose(12 months of age)Population: Safety population: all participants who received toddler dose vaccination (12 months of age).n= number of participants reporting yes for at least 1 day or no for all days for each treatment group respectively.
Systemic events (any fever \>=38 degrees Celsius \[C\], decreased appetite, irritability, increased sleep, decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.
Outcome measures
| Measure |
13vPnC
n=198 Participants
Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
|
7vPnC
n=200 Participants
Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
|
|---|---|---|
|
Percentage of Participants With Pre-specified Systemic Events: Toddler Dose (12 Months of Age)
Irritability (n= 174,183)
|
38.5 Percentage of participants
|
35.0 Percentage of participants
|
|
Percentage of Participants With Pre-specified Systemic Events: Toddler Dose (12 Months of Age)
Fever >=38 but <=39 degrees C (n= 161,154)
|
5.6 Percentage of participants
|
6.5 Percentage of participants
|
|
Percentage of Participants With Pre-specified Systemic Events: Toddler Dose (12 Months of Age)
Fever >39 but <=40 degrees (n= 160,152)
|
0.6 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Pre-specified Systemic Events: Toddler Dose (12 Months of Age)
Fever >40 degrees C (n= 160,152)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Pre-specified Systemic Events: Toddler Dose (12 Months of Age)
Decreased appetite (n= 174,179)
|
28.7 Percentage of participants
|
24.6 Percentage of participants
|
|
Percentage of Participants With Pre-specified Systemic Events: Toddler Dose (12 Months of Age)
Increased sleep (n= 171,170)
|
12.3 Percentage of participants
|
9.4 Percentage of participants
|
|
Percentage of Participants With Pre-specified Systemic Events: Toddler Dose (12 Months of Age)
Decreased sleep (n= 172,178)
|
22.7 Percentage of participants
|
27.0 Percentage of participants
|
|
Percentage of Participants With Pre-specified Systemic Events: Toddler Dose (12 Months of Age)
Any systemic event (n= 179,186)
|
54.7 Percentage of participants
|
52.7 Percentage of participants
|
Adverse Events
Infant Series 13vPnC
Serious events: 8 serious events
Other events: 330 other events
Deaths: 0 deaths
Infant Series 7vPnC
Serious events: 6 serious events
Other events: 316 other events
Deaths: 0 deaths
After the Infant Series 13vPnC
Serious events: 8 serious events
Other events: 5 other events
Deaths: 0 deaths
After the Infant Series 7vPnC
Serious events: 11 serious events
Other events: 9 other events
Deaths: 0 deaths
Toddler Dose 13vPnC
Serious events: 4 serious events
Other events: 98 other events
Deaths: 0 deaths
Toddler Dose 7vPnC
Serious events: 1 serious events
Other events: 98 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Infant Series 13vPnC
n=353 participants at risk
Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 6, 10 and 14 weeks of age (infant series), co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
|
Infant Series 7vPnC
n=353 participants at risk
Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series), co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
|
After the Infant Series 13vPnC
n=353 participants at risk
Participants received 1 single 0.5 mL dose of 13vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series), co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV). AEs were collected from approximately 1 month after Dose 3 to the Toddler dose.
|
After the Infant Series 7vPnC
n=353 participants at risk
Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series), co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV). AEs were collected from approximately 1 month after Dose 3 to the Toddler dose.
|
Toddler Dose 13vPnC
n=198 participants at risk
Participants received 1 single 0.5 mL dose of 13vPnC, administered intramuscularly, at 12 months of age (toddler dose).
|
Toddler Dose 7vPnC
n=200 participants at risk
Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 12 months of age (toddler dose).
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Cardiac failure congestive
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Gastrointestinal disorders
Infantile colic
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Infections and infestations
Bronchiolitis
|
0.57%
2/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
1.1%
4/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Infections and infestations
Bronchopneumonia
|
0.85%
3/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.51%
1/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Infections and infestations
Meningitis bacterial
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Infections and infestations
Viral infection
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Nervous system disorders
Convulsion
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Congenital, familial and genetic disorders
Heart disease congenital
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
General disorders
Pyrexia
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Hepatobiliary disorders
Hepatosplenomegaly
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
1.1%
4/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
1.0%
2/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.57%
2/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Infections and infestations
Lower respiratory tract infection viral
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.57%
2/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.57%
2/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Infections and infestations
Dysentery
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Infections and infestations
Sepsis
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Infections and infestations
Septic shock
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Infections and infestations
Viral myocarditis
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.57%
2/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute lymphocytic leukaemia
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Nervous system disorders
Febrile convulsion
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Nervous system disorders
Status epilepticus
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Psychiatric disorders
Breath holding
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.50%
1/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.51%
1/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
Other adverse events
| Measure |
Infant Series 13vPnC
n=353 participants at risk
Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 6, 10 and 14 weeks of age (infant series), co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
|
Infant Series 7vPnC
n=353 participants at risk
Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series), co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
|
After the Infant Series 13vPnC
n=353 participants at risk
Participants received 1 single 0.5 mL dose of 13vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series), co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV). AEs were collected from approximately 1 month after Dose 3 to the Toddler dose.
|
After the Infant Series 7vPnC
n=353 participants at risk
Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series), co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV). AEs were collected from approximately 1 month after Dose 3 to the Toddler dose.
|
Toddler Dose 13vPnC
n=198 participants at risk
Participants received 1 single 0.5 mL dose of 13vPnC, administered intramuscularly, at 12 months of age (toddler dose).
|
Toddler Dose 7vPnC
n=200 participants at risk
Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 12 months of age (toddler dose).
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Ventricular extrasystoles
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Ear and labyrinth disorders
Ear pain
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Ear and labyrinth disorders
Otorrhoea
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Eye disorders
Eye discharge
|
0.57%
2/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Eye disorders
Lacrimation increased
|
0.57%
2/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Gastrointestinal disorders
Diarrhoea
|
5.9%
21/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
7.4%
26/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.51%
1/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
1.5%
3/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Gastrointestinal disorders
Vomiting
|
1.1%
4/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
1.7%
6/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Gastrointestinal disorders
Constipation
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Gastrointestinal disorders
Infantile colic
|
0.57%
2/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Gastrointestinal disorders
Flatulence
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Gastrointestinal disorders
Perianal erythema
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
General disorders
Injection site pain
|
21.2%
75/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
19.8%
70/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
General disorders
Injection site swelling
|
15.6%
55/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
16.1%
57/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
General disorders
Pyrexia
|
8.2%
29/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
5.9%
21/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
1.0%
2/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
3.0%
6/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
General disorders
Injection site erythema
|
3.4%
12/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
3.4%
12/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
General disorders
Injection site nodule
|
1.4%
5/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
3.4%
12/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
General disorders
Irritability
|
64.4%
134/208 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
67.3%
140/208 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
—
0/0 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
—
0/0 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
—
0/0 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
—
0/0 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
General disorders
Tenderness
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Infections and infestations
Rhinitis
|
13.3%
47/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
10.5%
37/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.85%
3/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.51%
1/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
2.0%
4/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Infections and infestations
Upper respiratory tract infection
|
11.0%
39/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
12.7%
45/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.57%
2/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.57%
2/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
5.6%
11/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
3.0%
6/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Infections and infestations
Nasopharyngitis
|
3.1%
11/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
4.8%
17/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.51%
1/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
1.0%
2/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Infections and infestations
Gastroenteritis
|
2.3%
8/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
1.4%
5/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
1.0%
2/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
1.5%
3/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Infections and infestations
Lower respiratory tract infection
|
1.4%
5/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.57%
2/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Infections and infestations
Bronchiolitis
|
1.1%
4/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.57%
2/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.51%
1/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Infections and infestations
Respiratory tract infection
|
0.57%
2/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.85%
3/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Infections and infestations
Bronchopneumonia
|
0.57%
2/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Infections and infestations
Otitis media
|
0.57%
2/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Infections and infestations
Viral infection
|
0.57%
2/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.50%
1/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Infections and infestations
Acarodermatitis
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.57%
2/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.51%
1/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Infections and infestations
Omphalitis
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Infections and infestations
Viral diarrhoea
|
0.57%
2/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.50%
1/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Infections and infestations
Abscess neck
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Infections and infestations
Body tinea
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Infections and infestations
Bronchitis
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Infections and infestations
Fungal infection
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Infections and infestations
Impetigo
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Infections and infestations
Oral candidiasis
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Infections and infestations
Otitis candidiasis
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Infections and infestations
Rash pustular
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Infections and infestations
Respiratory tract infection viral
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.51%
1/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Infections and infestations
Viral rash
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Nervous system disorders
Crying
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Nervous system disorders
Convulsion
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Nervous system disorders
Somnolence
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Pregnancy, puerperium and perinatal conditions
Umbilical granuloma
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Reproductive system and breast disorders
Penile adhesion
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.5%
37/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
11.3%
40/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.57%
2/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
2.5%
5/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
3.0%
6/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Respiratory, thoracic and mediastinal disorders
Upper airway obstruction
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.85%
3/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.57%
2/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.57%
2/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.57%
2/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.57%
2/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.57%
2/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.57%
2/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.57%
2/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.57%
2/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Skin and subcutaneous tissue disorders
Acne infantile
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Skin and subcutaneous tissue disorders
Dandruff
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Congenital, familial and genetic disorders
Macrocephaly
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Infections and infestations
Tuberculosis
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Musculoskeletal and connective tissue disorders
Rickets
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Nervous system disorders
Febrile convulsion
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.28%
1/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.51%
1/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
1.0%
2/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Congenital, familial and genetic disorders
Phimosis
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.51%
1/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Immune system disorders
Allergy to arthropod bite
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.51%
1/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Infections and infestations
Furuncle
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.50%
1/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Metabolism and nutrition disorders
Decreased appetitie
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.50%
1/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.51%
1/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Vascular disorders
Pallor
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/353 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.51%
1/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.50%
1/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Skin and subcutaneous tissue disorders
Tenderness (any)
|
37.3%
76/204 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
38.0%
76/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
—
0/0 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
—
0/0 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
—
0/0 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
—
0/0 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Skin and subcutaneous tissue disorders
Tenderness (significant)
|
24.1%
48/199 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
23.5%
46/196 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
—
0/0 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
—
0/0 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
—
0/0 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
—
0/0 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Skin and subcutaneous tissue disorders
Induration (any)
|
17.2%
34/198 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
13.8%
27/195 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
—
0/0 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
—
0/0 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
—
0/0 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
—
0/0 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Skin and subcutaneous tissue disorders
Induration (mild)
|
15.8%
31/196 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
11.8%
23/195 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
—
0/0 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
—
0/0 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
—
0/0 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
—
0/0 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Skin and subcutaneous tissue disorders
Induration (moderate)
|
2.6%
5/193 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
3.6%
7/193 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
—
0/0 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
—
0/0 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
—
0/0 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
—
0/0 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Skin and subcutaneous tissue disorders
Induration (severe)
|
0.00%
0/191 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/193 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
—
0/0 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
—
0/0 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
—
0/0 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
—
0/0 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Skin and subcutaneous tissue disorders
Erythema (any)
|
10.4%
20/192 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
9.7%
19/195 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
—
0/0 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
—
0/0 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
—
0/0 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
—
0/0 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Skin and subcutaneous tissue disorders
Erythema (mild)
|
10.4%
20/192 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
9.2%
18/195 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
—
0/0 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
—
0/0 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
—
0/0 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
—
0/0 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Skin and subcutaneous tissue disorders
Erythema (moderate)
|
0.00%
0/191 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.52%
1/193 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
—
0/0 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
—
0/0 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
—
0/0 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
—
0/0 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
Skin and subcutaneous tissue disorders
Erythema (severe)
|
0.00%
0/191 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/193 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
—
0/0 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
—
0/0 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
—
0/0 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
—
0/0 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
General disorders
Fever ≥ 38 degrees Celsius [C] but ≤ 39 degrees C
|
19.8%
62/313 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
21.6%
70/324 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
—
0/0 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
—
0/0 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
5.6%
9/161 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
6.5%
10/154 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
General disorders
Fever ≥ 38 degrees C but ≤ 39 degrees C
|
7.7%
14/181 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
14.0%
24/172 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
—
0/0 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
—
0/0 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
—
0/0 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
—
0/0 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
General disorders
Fever > 39 degrees C but ≤ 40 degrees C
|
0.00%
0/179 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.00%
0/170 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
—
0/0 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
—
0/0 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
—
0/0 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
—
0/0 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
General disorders
Fever > 40 degrees C
|
0.00%
0/179 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
0.58%
1/171 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
—
0/0 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
—
0/0 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
—
0/0 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
—
0/0 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
General disorders
Decreased appetite
|
42.1%
85/202 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
41.0%
82/200 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
—
0/0 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
—
0/0 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
—
0/0 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
—
0/0 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
General disorders
Increased sleep
|
20.1%
40/199 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
20.5%
40/195 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
—
0/0 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
—
0/0 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
—
0/0 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
—
0/0 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
|
General disorders
Decreased sleep
|
42.4%
87/205 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
36.8%
74/201 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
—
0/0 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
—
0/0 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
—
0/0 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
—
0/0 • Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
|
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