Trial Outcomes & Findings for Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants. (NCT NCT00366340)
NCT ID: NCT00366340
Last Updated: 2012-08-08
Results Overview
Percentage of Participants achieving World Health Organization (WHO) predefined antibody threshold ≥0.35 μg/mL along with the corresponding 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 19A) are presented.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
604 participants
Primary outcome timeframe
One month after 3-dose infant series (5 months of age)
Results posted on
2012-08-08
Participant Flow
Participants were recruited in Germany from October 2006 to April 2007.
Participants were enrolled into the study according to inclusion/exclusion criteria without a screening period.
Participant milestones
| Measure |
13vPnC
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose).
|
7vPnC
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose)
|
|---|---|---|
|
Infant Series
STARTED
|
301
|
303
|
|
Infant Series
Vaccinated Dose 1
|
300
|
303
|
|
Infant Series
Vaccinated Dose 2
|
296
|
297
|
|
Infant Series
Vaccinated Dose 3
|
294
|
293
|
|
Infant Series
COMPLETED
|
293
|
293
|
|
Infant Series
NOT COMPLETED
|
8
|
10
|
|
After the Infant Series
STARTED
|
293
|
293
|
|
After the Infant Series
COMPLETED
|
290
|
287
|
|
After the Infant Series
NOT COMPLETED
|
3
|
6
|
|
Toddler Dose
STARTED
|
290
|
287
|
|
Toddler Dose
COMPLETED
|
289
|
286
|
|
Toddler Dose
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
13vPnC
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose).
|
7vPnC
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose)
|
|---|---|---|
|
Infant Series
Protocol Violation
|
3
|
4
|
|
Infant Series
Withdrawal by Subject
|
3
|
3
|
|
Infant Series
Adverse Event
|
0
|
2
|
|
Infant Series
Lost to Follow-up
|
1
|
1
|
|
Infant Series
Failure to return
|
1
|
0
|
|
After the Infant Series
Parent/legal guardian request
|
1
|
1
|
|
After the Infant Series
Failed to return
|
0
|
1
|
|
After the Infant Series
Protocol Violation
|
2
|
2
|
|
After the Infant Series
Adverse Event
|
0
|
1
|
|
After the Infant Series
Lost to Follow-up
|
0
|
1
|
|
Toddler Dose
Failed to return
|
1
|
0
|
|
Toddler Dose
Parent/legal guardian request
|
0
|
1
|
Baseline Characteristics
Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants.
Baseline characteristics by cohort
| Measure |
13vPnC
n=301 Participants
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose).
|
7vPnC
n=303 Participants
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose)
|
Total
n=604 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
2.5 months
STANDARD_DEVIATION 0.6 • n=5 Participants
|
2.5 months
STANDARD_DEVIATION 0.6 • n=7 Participants
|
2.5 months
STANDARD_DEVIATION 0.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
151 Participants
n=5 Participants
|
127 Participants
n=7 Participants
|
278 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
150 Participants
n=5 Participants
|
176 Participants
n=7 Participants
|
326 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: One month after 3-dose infant series (5 months of age)Population: Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations.
Percentage of Participants achieving World Health Organization (WHO) predefined antibody threshold ≥0.35 μg/mL along with the corresponding 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 19A) are presented.
Outcome measures
| Measure |
13vPnC
n=285 Participants
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose).
|
7vPnC
n=279 Participants
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose)
|
13vPnC After Toddler Dose
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age (toddler dose).
|
7vPnC After Toddler Dose
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age (toddler dose)
|
13vPnC Dose 3
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 4 months (infant series).
|
7vPnC Dose 3
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 4 months (infant series).
|
13vPnC Toddler Dose
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age.
|
7vPnC Toddler Dose
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Common Serotypes-Serotype 4
|
98.2 Percentage of Participants
Interval 96.0 to 99.4
|
98.2 Percentage of Participants
Interval 95.9 to 99.4
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Common Serotypes-Serotype 6B
|
77.5 Percentage of Participants
Interval 72.2 to 82.2
|
87.1 Percentage of Participants
Interval 82.5 to 90.8
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Common Serotypes-Serotype 9V
|
98.6 Percentage of Participants
Interval 96.4 to 99.6
|
96.4 Percentage of Participants
Interval 93.5 to 98.3
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Common Serotypes-Serotype 14
|
98.9 Percentage of Participants
Interval 96.9 to 99.8
|
97.5 Percentage of Participants
Interval 94.9 to 99.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Common Serotypes-Serotype 18C
|
97.2 Percentage of Participants
Interval 94.5 to 98.8
|
98.6 Percentage of Participants
Interval 96.3 to 99.6
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Common Serotypes-Serotype 19F
|
95.8 Percentage of Participants
Interval 92.7 to 97.8
|
96.0 Percentage of Participants
Interval 93.0 to 98.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Common Serotypes-Serotype 23F
|
88.7 Percentage of Participants
Interval 84.5 to 92.2
|
89.5 Percentage of Participants
Interval 85.3 to 92.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Additional Serotypes-Serotype 1
|
96.1 Percentage of Participants
Interval 93.2 to 98.1
|
1.4 Percentage of Participants
Interval 0.4 to 3.7
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Additional Serotypes-Serotype 3
|
98.2 Percentage of Participants
Interval 95.9 to 99.4
|
6.3 Percentage of Participants
Interval 3.7 to 9.8
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Additional Serotypes-Serotype 5
|
93.0 Percentage of Participants
Interval 89.3 to 95.6
|
31.6 Percentage of Participants
Interval 25.8 to 37.8
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Additional Serotypes-Serotype 6A
|
91.9 Percentage of Participants
Interval 88.1 to 94.8
|
31.6 Percentage of Participants
Interval 26.1 to 37.5
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Additional Serotypes-Serotype 7F
|
98.6 Percentage of Participants
Interval 96.4 to 99.6
|
4.0 Percentage of Participants
Interval 2.0 to 7.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Additional Serotypes-Serotype 19A
|
99.3 Percentage of Participants
Interval 97.5 to 99.9
|
79.2 Percentage of Participants
Interval 73.8 to 83.9
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: One month after 3-dose infant series (5 months of age)Population: Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations.
Antibody concentration/geometric mean concentration (GMC) as measured by enzyme-linked immunosorbent assay (ELISA) 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 ratios (13vPnC/7vPnC) and corresponding 2-sided 95% CI were evaluated.
Outcome measures
| Measure |
13vPnC
n=285 Participants
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose).
|
7vPnC
n=279 Participants
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose)
|
13vPnC After Toddler Dose
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age (toddler dose).
|
7vPnC After Toddler Dose
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age (toddler dose)
|
13vPnC Dose 3
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 4 months (infant series).
|
7vPnC Dose 3
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 4 months (infant series).
|
13vPnC Toddler Dose
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age.
|
7vPnC Toddler Dose
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age.
|
|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Common Serotypes - Serotype 4
|
2.18 μg/mL
Interval 1.98 to 2.4
|
2.99 μg/mL
Interval 2.68 to 3.33
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Common Serotypes - Serotype 6B
|
0.98 μg/mL
Interval 0.84 to 1.14
|
1.49 μg/mL
Interval 1.27 to 1.75
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Common Serotypes - Serotype 9V
|
1.65 μg/mL
Interval 1.51 to 1.8
|
1.96 μg/mL
Interval 1.77 to 2.17
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Common Serotypes - Serotype 14
|
4.14 μg/mL
Interval 3.68 to 4.66
|
4.61 μg/mL
Interval 4.07 to 5.23
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Common Serotypes - Serotype 18C
|
1.94 μg/mL
Interval 1.76 to 2.14
|
2.25 μg/mL
Interval 2.04 to 2.49
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Common Serotypes - Serotype 19F
|
1.73 μg/mL
Interval 1.56 to 1.92
|
2.86 μg/mL
Interval 2.53 to 3.24
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Common Serotypes - Serotype 23F
|
1.26 μg/mL
Interval 1.11 to 1.43
|
1.44 μg/mL
Interval 1.25 to 1.65
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Additional Serotypes - Serotype 1
|
1.83 μg/mL
Interval 1.64 to 2.04
|
0.03 μg/mL
Interval 0.02 to 0.03
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Additional Serotypes - Serotype 3
|
1.55 μg/mL
Interval 1.41 to 1.72
|
0.05 μg/mL
Interval 0.04 to 0.06
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Additional Serotypes - Serotype 5
|
1.31 μg/mL
Interval 1.17 to 1.46
|
0.20 μg/mL
Interval 0.18 to 0.23
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Additional Serotypes - Serotype 6A
|
1.33 μg/mL
Interval 1.18 to 1.49
|
0.23 μg/mL
Interval 0.2 to 0.26
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Additional Serotypes - Serotype 7F
|
2.59 μg/mL
Interval 2.36 to 2.85
|
0.04 μg/mL
Interval 0.04 to 0.05
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Additional Serotypes - Serotype 19A
|
3.26 μg/mL
Interval 2.97 to 3.59
|
0.64 μg/mL
Interval 0.58 to 0.71
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: One month after 3-dose infant series (5 months of age)Population: Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n)=number of participants with a determinate postinfant series OPA antibody titer to the given serotype.
Percentage of Participants achieving functional antibody titer ≥1:8 as measured by opsonophagocytic activity assay (OPA) along with the corresponding 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 19A) are presented.
Outcome measures
| Measure |
13vPnC
n=285 Participants
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose).
|
7vPnC
n=279 Participants
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose)
|
13vPnC After Toddler Dose
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age (toddler dose).
|
7vPnC After Toddler Dose
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age (toddler dose)
|
13vPnC Dose 3
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 4 months (infant series).
|
7vPnC Dose 3
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 4 months (infant series).
|
13vPnC Toddler Dose
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age.
|
7vPnC Toddler Dose
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series.
Common Serotypes - Serotype 4 (n=92,94)
|
100.0 Percentage of Participants
Interval 96.1 to 100.0
|
100.0 Percentage of Participants
Interval 96.2 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series.
Common Serotypes - Serotype 6B (n=100,94)
|
96.0 Percentage of Participants
Interval 90.1 to 98.9
|
98.9 Percentage of Participants
Interval 94.2 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series.
Common Serotypes - Serotype 9V (n=89,89)
|
100.0 Percentage of Participants
Interval 95.9 to 100.0
|
100.0 Percentage of Participants
Interval 95.9 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series.
Common Serotypes - Serotype 14 (n=95,89)
|
100.0 Percentage of Participants
Interval 96.2 to 100.0
|
100.0 Percentage of Participants
Interval 95.9 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series.
Common Serotypes - Serotype 18C (n=100,94)
|
100.0 Percentage of Participants
Interval 96.4 to 100.0
|
98.9 Percentage of Participants
Interval 94.2 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series.
Common Serotypes - Serotype 19F (n=100,94)
|
96.0 Percentage of Participants
Interval 90.1 to 98.9
|
93.6 Percentage of Participants
Interval 86.6 to 97.6
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series.
Common Serotypes - Serotype 23F (n=100,93)
|
96.0 Percentage of Participants
Interval 90.1 to 98.9
|
95.7 Percentage of Participants
Interval 89.4 to 98.8
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series.
Additional Serotypes - Serotype 1 (n=100,92)
|
93.0 Percentage of Participants
Interval 86.1 to 97.1
|
4.3 Percentage of Participants
Interval 1.2 to 10.8
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series.
Additional Serotypes - Serotype 3 (n=100,94)
|
99.0 Percentage of Participants
Interval 94.6 to 100.0
|
24.5 Percentage of Participants
Interval 16.2 to 34.4
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series.
Additional Serotypes - Serotype 5 (n=100,94)
|
99.0 Percentage of Participants
Interval 94.6 to 100.0
|
4.3 Percentage of Participants
Interval 1.2 to 10.5
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series.
Additional Serotypes - Serotype 6A (n=99,93)
|
96.0 Percentage of Participants
Interval 90.0 to 98.9
|
72.0 Percentage of Participants
Interval 61.8 to 80.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series.
Additional Serotypes - Serotype 7F (n=99,94)
|
100.0 Percentage of Participants
Interval 96.3 to 100.0
|
78.7 Percentage of Participants
Interval 69.1 to 86.5
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series.
Additional Serotypes - Serotype 19A (n=95,94)
|
100.00 Percentage of Participants
Interval 96.2 to 100.0
|
17.0 Percentage of Participants
Interval 10.1 to 26.2
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: One month after 3-dose infant series (5 months of age)Population: Evaluable immunogenicity (per protocol) population of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n)= number of participants with a determinate antibody titer for the specified serotype.
Antibody functionality/geometric mean titer (GMT) as measured by opsonophagocytic activity assay (OPA) 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.
Outcome measures
| Measure |
13vPnC
n=285 Participants
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose).
|
7vPnC
n=279 Participants
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose)
|
13vPnC After Toddler Dose
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age (toddler dose).
|
7vPnC After Toddler Dose
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age (toddler dose)
|
13vPnC Dose 3
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 4 months (infant series).
|
7vPnC Dose 3
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 4 months (infant series).
|
13vPnC Toddler Dose
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age.
|
7vPnC Toddler Dose
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age.
|
|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Antibody Titer in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Common Serotypes -Serotype 4 (n=92,94)
|
1573.29 titer
Interval 1283.03 to 1929.21
|
1860.79 titer
Interval 1540.0 to 2248.41
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Titer in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Common Serotypes - Serotype 6B (n=100,94)
|
744.43 titer
Interval 556.91 to 995.11
|
1160.76 titer
Interval 921.46 to 1462.19
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Titer in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Common Serotypes - Serotype 9V (n=89,89)
|
4937.84 titer
Interval 3614.78 to 6745.14
|
5379.51 titer
Interval 3935.51 to 7353.34
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Titer in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Common Serotypes - Serotype 14 (n=95,89)
|
2139.65 titer
Interval 1570.1 to 2915.79
|
3345.19 titer
Interval 2473.27 to 4524.5
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Titer in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Common Serotypes - Serotype 18C (n=100,94)
|
1509.65 titer
Interval 1243.64 to 1832.56
|
1780.26 titer
Interval 1382.42 to 2292.59
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Titer in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Common Serotypes - Serotype 19F (n=100,94)
|
150.12 titer
Interval 116.89 to 192.81
|
165.69 titer
Interval 122.98 to 223.23
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Titer in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Common Serotypes - Serotype 23F (n=100,93)
|
1089.92 titer
Interval 795.2 to 1493.86
|
1070.83 titer
Interval 786.59 to 1457.78
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Titer in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Additional Serotypes - Serotype 1 (n=100,92)
|
50.21 titer
Interval 39.39 to 64.02
|
4.15 titer
Interval 3.99 to 4.32
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Titer in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Additional Serotypes - Serotype 3 (n=100,94)
|
250.73 titer
Interval 205.52 to 305.89
|
6.13 titer
Interval 5.17 to 7.28
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Titer in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Additional Serotypes - Serotype 5 (n=100,94)
|
162.02 titer
Interval 126.31 to 207.82
|
4.64 titer
Interval 3.96 to 5.43
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Titer in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Additional Serotypes - Serotype 6A (n=99,93)
|
1228.45 titer
Interval 883.49 to 1708.11
|
122.40 titer
Interval 74.09 to 202.21
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Titer in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Additional Serotypes - Serotype 7F (n=99,94)
|
11544.75 titer
Interval 9364.02 to 14233.34
|
115.45 titer
Interval 75.16 to 177.32
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Titer in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Additional Serotypes - Serotype 19A (n=95,94)
|
442.48 titer
Interval 360.53 to 543.06
|
6.70 titer
Interval 5.19 to 8.66
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: One month after the infant series (5 months of age) ; one month after the toddler dose (13 months of age)Population: Evaluable immunogenicity (per protocol) population of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (N)= number of participants with a antibody concentration ≥ the prespecified level for the given concomitant antigen.
Predefined Antibody Levels for Haemophilus Influenzae Type b (0.15 µg/mL or 1.0 µg/mL), for Diphtheria Toxoid (0.01 or 0.1 International units \[IU\]/mL) and for Hepatitis B (≥ 10.0 mIU/mL).
Outcome measures
| Measure |
13vPnC
n=267 Participants
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose).
|
7vPnC
n=252 Participants
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose)
|
13vPnC After Toddler Dose
n=252 Participants
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age (toddler dose).
|
7vPnC After Toddler Dose
n=242 Participants
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age (toddler dose)
|
13vPnC Dose 3
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 4 months (infant series).
|
7vPnC Dose 3
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 4 months (infant series).
|
13vPnC Toddler Dose
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age.
|
7vPnC Toddler Dose
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose
Haemophilus influenzae type b 0.15 µg/mL threshold
|
89.5 Percentage of Participants
Interval 85.2 to 92.9
|
86.9 Percentage of Participants
Interval 82.1 to 90.8
|
100.0 Percentage of Participants
Interval 98.5 to 100.0
|
100.0 Percentage of Participants
Interval 98.5 to 100.0
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose
Haemophilus influenzae type b 1.0 µg/mL threshold
|
58.4 Percentage of Participants
Interval 52.3 to 64.4
|
54.0 Percentage of Participants
Interval 47.6 to 60.2
|
99.6 Percentage of Participants
Interval 97.8 to 100.0
|
97.9 Percentage of Participants
Interval 95.2 to 99.3
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose
Diphtheria toxoid at 0.01 IU/mL threshold
|
100.0 Percentage of Participants
Interval 98.7 to 100.0
|
100.0 Percentage of Participants
Interval 98.6 to 100.0
|
100.0 Percentage of Participants
Interval 98.6 to 100.0
|
100.0 Percentage of Participants
Interval 98.6 to 100.0
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose
Diphtheria toxoid at 0.1 IU/mL threshold
|
89.7 Percentage of Participants
Interval 85.5 to 93.0
|
94.2 Percentage of Participants
Interval 90.6 to 96.7
|
100.0 Percentage of Participants
Interval 98.6 to 100.0
|
100.0 Percentage of Participants
Interval 98.6 to 100.0
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose
Hepatitis B at ≥ 10.0 mIU/mL
|
94.9 Percentage of Participants
Interval 91.7 to 97.2
|
96.3 Percentage of Participants
Interval 93.2 to 98.2
|
99.3 Percentage of Participants
Interval 97.4 to 99.9
|
98.5 Percentage of Participants
Interval 96.1 to 99.6
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: One month after the infant series (5 months of age) ; one month after the toddler dose (13 months of age)Population: Evaluable immunogenicity (per protocol) population of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (N)= number of participants with a determinate antibody concentration for the specified concomitant antigen.
Outcome measures
| Measure |
13vPnC
n=267 Participants
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose).
|
7vPnC
n=252 Participants
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose)
|
13vPnC After Toddler Dose
n=285 Participants
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age (toddler dose).
|
7vPnC After Toddler Dose
n=279 Participants
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age (toddler dose)
|
13vPnC Dose 3
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 4 months (infant series).
|
7vPnC Dose 3
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 4 months (infant series).
|
13vPnC Toddler Dose
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age.
|
7vPnC Toddler Dose
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age.
|
|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Antibody Concentration of Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose
|
1.23 μg/mL
Interval 1.03 to 1.46
|
1.00 μg/mL
Interval 0.83 to 1.2
|
11.79 μg/mL
Interval 10.36 to 13.41
|
10.24 μg/mL
Interval 8.88 to 11.82
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: One month after the infant series (5 months of age) ; one month after the toddler dose (13 months of age)Population: Evaluable immunogenicity (per protocol) population of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (N)= number of participants with a determinate antibody concentration for the specified concomitant antigen.
Outcome measures
| Measure |
13vPnC
n=272 Participants
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose).
|
7vPnC
n=258 Participants
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose)
|
13vPnC After Toddler Dose
n=285 Participants
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age (toddler dose).
|
7vPnC After Toddler Dose
n=279 Participants
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age (toddler dose)
|
13vPnC Dose 3
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 4 months (infant series).
|
7vPnC Dose 3
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 4 months (infant series).
|
13vPnC Toddler Dose
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age.
|
7vPnC Toddler Dose
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age.
|
|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Antibody Concentration of Diphtheria Toxoid in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose
|
0.36 IU/mL
Interval 0.32 to 0.41
|
0.53 IU/mL
Interval 0.47 to 0.6
|
2.67 IU/mL
Interval 2.44 to 2.93
|
3.08 IU/mL
Interval 2.74 to 3.47
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: One month after the infant series (5 months of age) ; one month after the toddler dose (13 months of age)Population: Evaluable immunogenicity (per protocol) population of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (N)= number of participants with a determinate antibody concentration for the specified concomitant antigen.
Antibody geometric mean concentration (GMC) as measured by 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.
Outcome measures
| Measure |
13vPnC
n=277 Participants
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose).
|
7vPnC
n=268 Participants
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose)
|
13vPnC After Toddler Dose
n=285 Participants
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age (toddler dose).
|
7vPnC After Toddler Dose
n=279 Participants
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age (toddler dose)
|
13vPnC Dose 3
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 4 months (infant series).
|
7vPnC Dose 3
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 4 months (infant series).
|
13vPnC Toddler Dose
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age.
|
7vPnC Toddler Dose
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age.
|
|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Antibody Concentration of Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose
|
145.19 mIU/mL
Interval 122.62 to 171.92
|
165.25 mIU/mL
Interval 140.33 to 194.61
|
1118.05 mIU/mL
Interval 935.26 to 1336.56
|
1195.82 mIU/mL
Interval 976.12 to 1464.98
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Immediately before (12 months of age) and one month after the toddler dose (13 months of age)Population: Evaluable immunogenicity (per protocol) population of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n)= number of participants with a determinate antibody concentration for the specified concomitant antigen.
Antibody concentration/geometric mean concentration as measured by ELISA with their corresponding 95% CI immediately before and after the toddler dose 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.
Outcome measures
| Measure |
13vPnC
n=285 Participants
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose).
|
7vPnC
n=279 Participants
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose)
|
13vPnC After Toddler Dose
n=285 Participants
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age (toddler dose).
|
7vPnC After Toddler Dose
n=279 Participants
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age (toddler dose)
|
13vPnC Dose 3
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 4 months (infant series).
|
7vPnC Dose 3
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 4 months (infant series).
|
13vPnC Toddler Dose
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age.
|
7vPnC Toddler Dose
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age.
|
|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose
Common Serotypes -Serotype 4 (n=277,264,276,263)
|
0.46 μg/mL
Interval 0.42 to 0.51
|
0.58 μg/mL
Interval 0.53 to 0.64
|
4.16 μg/mL
Interval 3.75 to 4.62
|
5.07 μg/mL
Interval 4.53 to 5.67
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose
Common Serotypes - Serotype 6B (n=275,261,273,251)
|
0.97 μg/mL
Interval 0.87 to 1.07
|
1.06 μg/mL
Interval 0.94 to 1.2
|
9.14 μg/mL
Interval 8.14 to 10.26
|
9.85 μg/mL
Interval 8.66 to 11.22
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose
Common Serotypes - Serotype 9V (n=277,265,277,262)
|
0.46 μg/mL
Interval 0.42 to 0.5
|
0.52 μg/mL
Interval 0.48 to 0.57
|
2.75 μg/mL
Interval 2.52 to 2.99
|
3.36 μg/mL
Interval 3.02 to 3.73
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose
Common Serotypes - Serotype 14 (n=273,263,276,260)
|
2.20 μg/mL
Interval 1.96 to 2.48
|
2.65 μg/mL
Interval 2.34 to 3.0
|
8.34 μg/mL
Interval 7.5 to 9.28
|
11.01 μg/mL
Interval 9.87 to 12.29
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose
Common Serotypes-Serotype 18C (n=277,265,276,263)
|
0.33 μg/mL
Interval 0.3 to 0.36
|
0.39 μg/mL
Interval 0.36 to 0.43
|
2.79 μg/mL
Interval 2.53 to 3.07
|
3.44 μg/mL
Interval 3.08 to 3.84
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose
Common Serotypes-Serotype 19F (n=276,264,276,263)
|
0.68 μg/mL
Interval 0.6 to 0.76
|
0.58 μg/mL
Interval 0.52 to 0.66
|
5.99 μg/mL
Interval 5.36 to 6.68
|
4.72 μg/mL
Interval 4.12 to 5.41
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose
Common Serotypes-Serotype 23F (n=275,264,277,264)
|
0.33 μg/mL
Interval 0.3 to 0.37
|
0.39 μg/mL
Interval 0.34 to 0.45
|
3.36 μg/mL
Interval 2.98 to 3.78
|
4.33 μg/mL
Interval 3.75 to 5.0
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose
Additional - Serotype 1 (n=277,264,278,257)
|
0.52 μg/mL
Interval 0.48 to 0.57
|
0.03 μg/mL
Interval 0.02 to 0.03
|
4.25 μg/mL
Interval 3.8 to 4.75
|
0.03 μg/mL
Interval 0.03 to 0.04
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose
Additional - Serotype 3 (n=275,264,278,255)
|
0.25 μg/mL
Interval 0.23 to 0.28
|
0.05 μg/mL
Interval 0.05 to 0.06
|
1.02 μg/mL
Interval 0.92 to 1.13
|
0.07 μg/mL
Interval 0.06 to 0.08
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose
Additional - Serotype 5 (n=275,264,276,220)
|
0.74 μg/mL
Interval 0.67 to 0.81
|
0.34 μg/mL
Interval 0.3 to 0.39
|
3.56 μg/mL
Interval 3.25 to 3.89
|
0.51 μg/mL
Interval 0.45 to 0.58
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose
Additional - Serotype 6A (n=276,264,274,255)
|
0.76 μg/mL
Interval 0.68 to 0.85
|
0.33 μg/mL
Interval 0.29 to 0.37
|
5.88 μg/mL
Interval 5.24 to 6.59
|
1.74 μg/mL
Interval 1.51 to 2.01
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose
Additional - Serotype 7F (n=277,264,278,263)
|
0.99 μg/mL
Interval 0.91 to 1.08
|
0.04 μg/mL
Interval 0.04 to 0.04
|
4.79 μg/mL
Interval 4.29 to 5.34
|
0.05 μg/mL
Interval 0.04 to 0.05
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose
Additional - Serotype 19A (n=277,264,271,260)
|
1.28 μg/mL
Interval 1.14 to 1.45
|
0.72 μg/mL
Interval 0.65 to 0.8
|
9.58 μg/mL
Interval 8.68 to 10.58
|
3.79 μg/mL
Interval 3.4 to 4.21
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 through 4 after each dosePopulation: Safety population, included participants who received given dose; (n) = number of participants reporting the specific characteristic.
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (Sig) (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 centimeters \[cm\] to 2.0 cm); Moderate (Mod)(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 one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose).
|
7vPnC
n=303 Participants
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose)
|
13vPnC After Toddler Dose
n=296 Participants
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age (toddler dose).
|
7vPnC After Toddler Dose
n=297 Participants
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age (toddler dose)
|
13vPnC Dose 3
n=294 Participants
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 4 months (infant series).
|
7vPnC Dose 3
n=293 Participants
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 4 months (infant series).
|
13vPnC Toddler Dose
n=290 Participants
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age.
|
7vPnC Toddler Dose
n=287 Participants
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Reporting Pre-Specified Local Reactions
Tenderness-Any (n=267,267,250,241,229,221,206,96)
|
33.0 percentage of participants
|
32.6 percentage of participants
|
29.2 percentage of participants
|
31.5 percentage of participants
|
27.1 percentage of participants
|
21.3 percentage of participants
|
53.4 percentage of participants
|
51.9 percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions
Tenderness-Sig (n=260,258,236,226,215,209,176,158)
|
7.7 percentage of participants
|
7.0 percentage of participants
|
4.7 percentage of participants
|
7.5 percentage of participants
|
4.2 percentage of participants
|
2.9 percentage of participants
|
10.8 percentage of participants
|
12.7 percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions
Swelling-Any (n=266,263,244,242,226,224,190,176)
|
28.2 percentage of participants
|
20.5 percentage of participants
|
26.6 percentage of participants
|
35.1 percentage of participants
|
26.1 percentage of participants
|
28.6 percentage of participants
|
36.8 percentage of participants
|
43.8 percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions
Swelling-Mild (n=265,263,243,239,226,223,186,172)
|
24.5 percentage of participants
|
19.0 percentage of participants
|
24.3 percentage of participants
|
33.5 percentage of participants
|
24.8 percentage of participants
|
27.8 percentage of participants
|
33.3 percentage of participants
|
40.7 percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions
Swelling-Mod (n=261,256,235,227,217,211,174,158)
|
7.3 percentage of participants
|
5.9 percentage of participants
|
7.7 percentage of participants
|
6.6 percentage of participants
|
6.9 percentage of participants
|
5.2 percentage of participants
|
12.1 percentage of participants
|
12.7 percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions
Swelling-Severe(n=259,255,232,223,214,208,166,152)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions
Redness-Any (n=266,272,247,252,238,231,196,184)
|
28.2 percentage of participants
|
36.4 percentage of participants
|
34.4 percentage of participants
|
46.8 percentage of participants
|
34.9 percentage of participants
|
39.8 percentage of participants
|
47.4 percentage of participants
|
56.0 percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions
Redness-Mild (n=265,271,247,250,237,229,191,180)
|
27.2 percentage of participants
|
36.2 percentage of participants
|
33.6 percentage of participants
|
45.6 percentage of participants
|
34.2 percentage of participants
|
38.9 percentage of participants
|
44.5 percentage of participants
|
52.8 percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions
Redness-Mod (n=260,256,232,224,217,210,173,158)
|
1.9 percentage of participants
|
1.6 percentage of participants
|
1.7 percentage of participants
|
3.6 percentage of participants
|
4.6 percentage of participants
|
2.4 percentage of participants
|
11.6 percentage of participants
|
15.2 percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions
Redness-Severe (n=259,255,232,222,214,208,166,153)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.7 percentage of participants
|
PRIMARY outcome
Timeframe: Day 1 through 4 after each dosePopulation: Safety population, participants who received given dose; (n)= number of participants reporting yes for at least 1 day or no for all days.
Systemic events (any fever ≥ 38 degrees Celsius \[C\], decreased appetite, irritability, increased sleep, decreased sleep, and hives \[urticaria\]) were reported using an electronic diary. Participants may be represented in more than 1 category.
Outcome measures
| Measure |
13vPnC
n=300 Participants
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose).
|
7vPnC
n=303 Participants
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose)
|
13vPnC After Toddler Dose
n=296 Participants
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age (toddler dose).
|
7vPnC After Toddler Dose
n=297 Participants
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age (toddler dose)
|
13vPnC Dose 3
n=294 Participants
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 4 months (infant series).
|
7vPnC Dose 3
n=293 Participants
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 4 months (infant series).
|
13vPnC Toddler Dose
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age.
|
7vPnC Toddler Dose
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series)
Fever ≥38°C but ≤ 39°C (n=269,266,248,250,242,232)
|
43.5 percentage of participants
|
38.7 percentage of participants
|
46.8 percentage of participants
|
48.4 percentage of participants
|
46.3 percentage of participants
|
36.6 percentage of participants
|
—
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series)
Fever >39°C but ≤40°C (n=260,256,238,225,216,210)
|
4.2 percentage of participants
|
1.6 percentage of participants
|
8.8 percentage of participants
|
4.4 percentage of participants
|
3.7 percentage of participants
|
1.4 percentage of participants
|
—
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series)
Fever >40°C (n=259,256,233,223,216,209)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series)
Decreased Appetite (n=269,267,249,245,236,225)
|
33.1 percentage of participants
|
30.3 percentage of participants
|
33.7 percentage of participants
|
34.3 percentage of participants
|
33.1 percentage of participants
|
30.2 percentage of participants
|
—
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series)
Irritability (n=275,266,254,252,238,235)
|
42.5 percentage of participants
|
45.1 percentage of participants
|
47.2 percentage of participants
|
55.2 percentage of participants
|
45.4 percentage of participants
|
48.9 percentage of participants
|
—
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series)
Increased Sleep (n=284,272,258,256,240,241)
|
61.6 percentage of participants
|
58.8 percentage of participants
|
53.9 percentage of participants
|
66.8 percentage of participants
|
49.6 percentage of participants
|
49.4 percentage of participants
|
—
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series)
Decreased Sleep (n=266,264,240,234,230,221)
|
25.2 percentage of participants
|
26.1 percentage of participants
|
23.8 percentage of participants
|
23.1 percentage of participants
|
20.9 percentage of participants
|
24.4 percentage of participants
|
—
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series)
Meds to Prevent Sx (n=261,262,237,234,220,220)
|
8.8 percentage of participants
|
9.5 percentage of participants
|
10.1 percentage of participants
|
15.4 percentage of participants
|
10.0 percentage of participants
|
15.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series)
Meds to Treat Sx (n=263,266,244,235,226,225)
|
20.2 percentage of participants
|
21.1 percentage of participants
|
28.3 percentage of participants
|
27.2 percentage of participants
|
20.8 percentage of participants
|
19.1 percentage of participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 through 4 after each dosePopulation: Safety population, participants who received given dose; (n)= number of participants reporting yes for at least 1 day or no for all days.
Systemic events (any fever ≥ 38 degrees Celsius \[C\], decreased appetite, irritability, increased sleep, decreased sleep, and hives \[urticaria\]) were reported using an electronic diary. Participants may be represented in more than 1 category.
Outcome measures
| Measure |
13vPnC
n=290 Participants
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose).
|
7vPnC
n=287 Participants
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose)
|
13vPnC After Toddler Dose
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age (toddler dose).
|
7vPnC After Toddler Dose
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age (toddler dose)
|
13vPnC Dose 3
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 4 months (infant series).
|
7vPnC Dose 3
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 4 months (infant series).
|
13vPnC Toddler Dose
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age.
|
7vPnC Toddler Dose
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Reporting Pre-Specified Systemic Events (Toddler Series)
Fever ≥38°C but ≤ 39°C (n=206,200)
|
58.7 percentage of participants
|
62.0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events (Toddler Series)
Fever >39°C but ≤40°C (n=174,157)
|
12.6 percentage of participants
|
8.9 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events (Toddler Series)
Fever >40°C (n=166,152)
|
0.6 percentage of participants
|
0.0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events (Toddler Series)
Decreased Appetite (n=204,192)
|
43.6 percentage of participants
|
46.4 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events (Toddler Series)
Irritability (n=213,200)
|
55.4 percentage of participants
|
61.0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events (Toddler Series)
Increased Sleep (n=202,197)
|
56.4 percentage of participants
|
54.8 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events (Toddler Series)
Decreased Sleep (n=195,170)
|
31.8 percentage of participants
|
28.8 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events (Toddler Series)
Medication to Prevent Symptoms (n=184,182)
|
32.1 percentage of participants
|
33.0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events (Toddler Series)
Medication to Treat Symptoms (n=178,167)
|
18.0 percentage of participants
|
18.6 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
13vPnC Infant Series
Serious events: 12 serious events
Other events: 220 other events
Deaths: 0 deaths
7vPnC Infant Series
Serious events: 10 serious events
Other events: 225 other events
Deaths: 0 deaths
13vPnC Post-Infant Series
Serious events: 21 serious events
Other events: 13 other events
Deaths: 0 deaths
7vPnC Post-Infant Series
Serious events: 23 serious events
Other events: 25 other events
Deaths: 0 deaths
13vPnC Toddler Dose
Serious events: 3 serious events
Other events: 152 other events
Deaths: 0 deaths
7vPnC Toddler Dose
Serious events: 4 serious events
Other events: 143 other events
Deaths: 0 deaths
13vPnC 6-Month Follow-up
Serious events: 11 serious events
Other events: 11 other events
Deaths: 0 deaths
7vPnC 6-Month Follow-up
Serious events: 14 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
13vPnC Infant Series
n=299 participants at risk；n=300 participants at risk
Participants received one single 0.5mL dose of 13vPnC coadministered with Infanrix hexa at 2, 3, 4 months. Adverse events were collected from dose 1 to approximately one month after dose 3.
|
7vPnC Infant Series
n=300 participants at risk；n=303 participants at risk
Participants received one single 0.5mL dose of 7vPnC coadministered with Infanrix hexa at 2, 3, 4 months. Adverse events were collected from dose 1 to approximately one month after dose 3.
|
13vPnC Post-Infant Series
n=299 participants at risk；n=300 participants at risk
Participants received one single 0.5mL dose of 13vPnC coadministered with Infanrix hexa at 2, 3, 4 months. Adverse events were collected from approximately one month after dose 3 to toddler dose.
|
7vPnC Post-Infant Series
n=300 participants at risk；n=303 participants at risk
Participants received one single 0.5mL dose of 7vPnC coadministered with Infanrix hexa at 2, 3, 4 months (infant series) and 12 months of age (toddler dose). Adverse events were collected from approximately one month after dose 3 to toddler dose.
|
13vPnC Toddler Dose
n=289 participants at risk；n=300 participants at risk
Participants received one single 0.5mL dose of 13vPnC at 12 months of age. Adverse events were collected for approximately one month after toddler dose.
|
7vPnC Toddler Dose
n=284 participants at risk；n=303 participants at risk
Participants received one single 0.5mL dose of 7vPnC coadministered with Infanrix hexa at 12 months of age. Adverse events were collected for approximately one month after toddler dose.
|
13vPnC 6-Month Follow-up
n=287 participants at risk；n=300 participants at risk
Participants received one single 0.5mL dose of 13vPnC coadministered with Infanrix hexa at 2, 3, 4 months (infant series) and 12 months of age (toddler dose). Adverse events were collected for approximately six months after last visit.
|
7vPnC 6-Month Follow-up
n=287 participants at risk；n=303 participants at risk
Participants received one single 0.5mL dose of 7vPnC coadministered with Infanrix hexa at 2, 3, 4 months (infant series) and 12 months of age (toddler dose). Adverse events were collected for approximately six months after last visit.
|
|---|---|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Accidental exposure
|
0.00%
0/300
|
0.00%
0/303
|
0.33%
1/300
|
0.00%
0/303
|
0.00%
0/300
|
0.00%
0/303
|
0.00%
0/300
|
0.00%
0/303
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/300
|
0.00%
0/303
|
0.33%
1/300
|
0.00%
0/303
|
0.00%
0/300
|
0.00%
0/303
|
0.00%
0/300
|
0.00%
0/303
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.00%
0/300
|
0.00%
0/303
|
0.00%
0/300
|
0.00%
0/303
|
0.00%
0/300
|
0.00%
0/303
|
0.00%
0/300
|
0.33%
1/303
|
|
Respiratory, thoracic and mediastinal disorders
Apnoeic attack
|
0.33%
1/300
|
0.00%
0/303
|
0.00%
0/300
|
0.00%
0/303
|
0.00%
0/300
|
0.00%
0/303
|
0.00%
0/300
|
0.00%
0/303
|
|
Injury, poisoning and procedural complications
Brain contusion
|
0.00%
0/300
|
0.00%
0/303
|
0.00%
0/300
|
0.00%
0/303
|
0.00%
0/300
|
0.00%
0/303
|
0.33%
1/300
|
0.00%
0/303
|
|
Infections and infestations
Bronchiolitis
|
0.33%
1/300
|
0.00%
0/303
|
0.00%
0/300
|
0.00%
0/303
|
0.00%
0/300
|
0.00%
0/303
|
0.00%
0/300
|
0.00%
0/303
|
|
Infections and infestations
Bronchitis
|
0.67%
2/300
|
1.3%
4/303
|
0.33%
1/300
|
0.00%
0/303
|
0.00%
0/300
|
0.33%
1/303
|
0.00%
0/300
|
0.00%
0/303
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/300
|
0.00%
0/303
|
0.33%
1/300
|
0.00%
0/303
|
0.00%
0/300
|
0.00%
0/303
|
0.00%
0/300
|
0.00%
0/303
|
|
Injury, poisoning and procedural complications
Chemical poisoning
|
0.00%
0/300
|
0.00%
0/303
|
0.33%
1/300
|
0.33%
1/303
|
0.00%
0/300
|
0.00%
0/303
|
0.00%
0/300
|
0.00%
0/303
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/300
|
0.33%
1/303
|
0.33%
1/300
|
0.00%
0/303
|
0.33%
1/300
|
0.00%
0/303
|
0.33%
1/300
|
0.00%
0/303
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/300
|
0.00%
0/303
|
0.33%
1/300
|
0.00%
0/303
|
0.00%
0/300
|
0.00%
0/303
|
0.00%
0/300
|
0.00%
0/303
|
|
Infections and infestations
Croup infectious
|
0.00%
0/300
|
0.00%
0/303
|
0.00%
0/300
|
0.33%
1/303
|
0.00%
0/300
|
0.00%
0/303
|
0.00%
0/300
|
0.00%
0/303
|
|
Infections and infestations
Cystitis
|
0.00%
0/300
|
0.00%
0/303
|
0.33%
1/300
|
0.00%
0/303
|
0.00%
0/300
|
0.00%
0/303
|
0.00%
0/300
|
0.00%
0/303
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.33%
1/300
|
0.00%
0/303
|
0.00%
0/300
|
0.00%
0/303
|
0.00%
0/300
|
0.00%
0/303
|
0.00%
0/300
|
0.00%
0/303
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/300
|
0.00%
0/303
|
0.00%
0/300
|
0.33%
1/303
|
0.33%
1/300
|
0.00%
0/303
|
0.67%
2/300
|
0.33%
1/303
|
|
Infections and infestations
Ear infection
|
0.00%
0/300
|
0.00%
0/303
|
0.00%
0/300
|
0.00%
0/303
|
0.00%
0/300
|
0.00%
0/303
|
0.00%
0/300
|
0.33%
1/303
|
|
Infections and infestations
Enteritis infectious
|
0.00%
0/300
|
0.00%
0/303
|
0.00%
0/300
|
0.00%
0/303
|
0.00%
0/300
|
0.00%
0/303
|
0.33%
1/300
|
0.00%
0/303
|
|
Reproductive system and breast disorders
Epididymitis
|
0.33%
1/300
|
0.00%
0/303
|
0.00%
0/300
|
0.00%
0/303
|
0.00%
0/300
|
0.00%
0/303
|
0.00%
0/300
|
0.00%
0/303
|
|
Injury, poisoning and procedural complications
Exposure to toxic agent
|
0.00%
0/300
|
0.00%
0/303
|
0.00%
0/300
|
0.00%
0/303
|
0.00%
0/300
|
0.00%
0/303
|
0.00%
0/300
|
0.33%
1/303
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.33%
1/300
|
0.00%
0/303
|
0.33%
1/300
|
0.00%
0/303
|
0.00%
0/300
|
0.00%
0/303
|
0.00%
0/300
|
0.00%
0/303
|
|
Nervous system disorders
Febrile convulsion
|
0.00%
0/300
|
0.00%
0/303
|
0.33%
1/300
|
0.33%
1/303
|
0.00%
0/300
|
0.33%
1/303
|
0.00%
0/300
|
0.66%
2/303
|
|
Infections and infestations
Febrile infection
|
0.33%
1/300
|
0.00%
0/303
|
0.00%
0/300
|
0.00%
0/303
|
0.00%
0/300
|
0.00%
0/303
|
0.00%
0/300
|
0.00%
0/303
|
|
Infections and infestations
Gastroenteritis
|
0.33%
1/300
|
0.00%
0/303
|
0.33%
1/300
|
1.3%
4/303
|
0.33%
1/300
|
0.33%
1/303
|
1.0%
3/300
|
0.99%
3/303
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.00%
0/300
|
0.00%
0/303
|
0.00%
0/300
|
0.33%
1/303
|
0.00%
0/300
|
0.00%
0/303
|
0.00%
0/300
|
0.00%
0/303
|
|
Infections and infestations
Gastroenteritis rotavirus
|
0.67%
2/300
|
0.66%
2/303
|
0.67%
2/300
|
0.99%
3/303
|
0.33%
1/300
|
0.33%
1/303
|
0.33%
1/300
|
0.99%
3/303
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/300
|
0.00%
0/303
|
0.00%
0/300
|
0.00%
0/303
|
0.00%
0/300
|
0.00%
0/303
|
0.00%
0/300
|
0.33%
1/303
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/300
|
0.00%
0/303
|
0.33%
1/300
|
0.00%
0/303
|
0.00%
0/300
|
0.00%
0/303
|
0.33%
1/300
|
0.00%
0/303
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.00%
0/300
|
0.00%
0/303
|
0.00%
0/300
|
0.33%
1/303
|
0.00%
0/300
|
0.00%
0/303
|
0.00%
0/300
|
0.00%
0/303
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/300
|
0.33%
1/303
|
0.00%
0/300
|
0.00%
0/303
|
0.00%
0/300
|
0.00%
0/303
|
0.00%
0/300
|
0.00%
0/303
|
|
Gastrointestinal disorders
Intussusception
|
0.00%
0/300
|
0.00%
0/303
|
0.00%
0/300
|
0.33%
1/303
|
0.00%
0/300
|
0.00%
0/303
|
0.00%
0/300
|
0.00%
0/303
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/300
|
0.00%
0/303
|
0.00%
0/300
|
0.00%
0/303
|
0.00%
0/300
|
0.00%
0/303
|
0.33%
1/300
|
0.00%
0/303
|
|
Gastrointestinal disorders
Mechanical ileus
|
0.00%
0/300
|
0.00%
0/303
|
0.00%
0/300
|
0.33%
1/303
|
0.00%
0/300
|
0.00%
0/303
|
0.00%
0/300
|
0.00%
0/303
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/300
|
0.00%
0/303
|
0.00%
0/300
|
0.00%
0/303
|
0.00%
0/300
|
0.00%
0/303
|
0.33%
1/300
|
0.00%
0/303
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/300
|
0.00%
0/303
|
0.33%
1/300
|
0.00%
0/303
|
0.00%
0/300
|
0.00%
0/303
|
0.00%
0/300
|
0.00%
0/303
|
|
Injury, poisoning and procedural complications
Nicotine poisoning
|
0.00%
0/300
|
0.00%
0/303
|
0.00%
0/300
|
0.00%
0/303
|
0.00%
0/300
|
0.00%
0/303
|
0.00%
0/300
|
0.33%
1/303
|
|
Infections and infestations
Otitis media
|
0.00%
0/300
|
0.00%
0/303
|
0.33%
1/300
|
0.00%
0/303
|
0.00%
0/300
|
0.00%
0/303
|
0.33%
1/300
|
0.00%
0/303
|
|
Infections and infestations
Periorbital cellulitis
|
0.00%
0/300
|
0.00%
0/303
|
0.00%
0/300
|
0.00%
0/303
|
0.00%
0/300
|
0.00%
0/303
|
0.33%
1/300
|
0.00%
0/303
|
|
Infections and infestations
Pharyngotonsillitis
|
0.00%
0/300
|
0.00%
0/303
|
0.00%
0/300
|
0.00%
0/303
|
0.00%
0/300
|
0.00%
0/303
|
0.33%
1/300
|
0.00%
0/303
|
|
Infections and infestations
Pneumonia
|
0.00%
0/300
|
0.33%
1/303
|
0.33%
1/300
|
0.33%
1/303
|
0.00%
0/300
|
0.00%
0/303
|
0.00%
0/300
|
0.00%
0/303
|
|
Infections and infestations
Pneumonia respiratory syncytial viral
|
0.33%
1/300
|
0.00%
0/303
|
0.00%
0/300
|
0.00%
0/303
|
0.00%
0/300
|
0.00%
0/303
|
0.00%
0/300
|
0.00%
0/303
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/300
|
0.00%
0/303
|
0.00%
0/300
|
0.66%
2/303
|
0.00%
0/300
|
0.00%
0/303
|
0.00%
0/300
|
0.00%
0/303
|
|
Infections and infestations
Pyelonephritis acute
|
0.33%
1/300
|
0.00%
0/303
|
0.00%
0/300
|
0.00%
0/303
|
0.00%
0/300
|
0.00%
0/303
|
0.00%
0/300
|
0.00%
0/303
|
|
General disorders
Pyrexia
|
0.00%
0/300
|
0.00%
0/303
|
0.00%
0/300
|
0.33%
1/303
|
0.00%
0/300
|
0.00%
0/303
|
0.00%
0/300
|
0.00%
0/303
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/300
|
0.00%
0/303
|
0.33%
1/300
|
0.00%
0/303
|
0.00%
0/300
|
0.00%
0/303
|
0.00%
0/300
|
0.00%
0/303
|
|
Infections and infestations
Respiratory syncytial virus bronchiolitis
|
0.00%
0/300
|
0.66%
2/303
|
0.00%
0/300
|
0.00%
0/303
|
0.00%
0/300
|
0.00%
0/303
|
0.00%
0/300
|
0.00%
0/303
|
|
Infections and infestations
Rhinitis
|
0.00%
0/300
|
0.00%
0/303
|
0.00%
0/300
|
0.00%
0/303
|
0.00%
0/300
|
0.00%
0/303
|
0.00%
0/300
|
0.33%
1/303
|
|
Infections and infestations
Rotavirus infection
|
0.00%
0/300
|
0.00%
0/303
|
0.00%
0/300
|
0.00%
0/303
|
0.00%
0/300
|
0.00%
0/303
|
0.00%
0/300
|
0.33%
1/303
|
|
Injury, poisoning and procedural complications
Skeletal injury
|
0.00%
0/300
|
0.00%
0/303
|
0.67%
2/300
|
0.99%
3/303
|
0.00%
0/300
|
0.00%
0/303
|
0.00%
0/300
|
0.66%
2/303
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/300
|
0.33%
1/303
|
0.00%
0/300
|
0.00%
0/303
|
0.00%
0/300
|
0.33%
1/303
|
0.00%
0/300
|
0.00%
0/303
|
|
Infections and infestations
Urinary tract infection
|
0.33%
1/300
|
0.33%
1/303
|
0.00%
0/300
|
0.00%
0/303
|
0.00%
0/300
|
0.00%
0/303
|
0.00%
0/300
|
0.00%
0/303
|
|
Renal and urinary disorders
Vesicoureteric reflux
|
0.00%
0/300
|
0.00%
0/303
|
0.00%
0/300
|
0.00%
0/303
|
0.00%
0/300
|
0.00%
0/303
|
0.33%
1/300
|
0.00%
0/303
|
|
Infections and infestations
Viral infection
|
0.00%
0/300
|
0.00%
0/303
|
0.33%
1/300
|
0.00%
0/303
|
0.00%
0/300
|
0.00%
0/303
|
0.00%
0/300
|
0.33%
1/303
|
|
Infections and infestations
Viral tonsillitis
|
0.33%
1/300
|
0.00%
0/303
|
0.00%
0/300
|
0.00%
0/303
|
0.00%
0/300
|
0.00%
0/303
|
0.00%
0/300
|
0.00%
0/303
|
|
Congenital, familial and genetic disorders
Vitello-intestinal duct remnant
|
0.00%
0/300
|
0.00%
0/303
|
0.00%
0/300
|
0.33%
1/303
|
0.00%
0/300
|
0.00%
0/303
|
0.00%
0/300
|
0.00%
0/303
|
Other adverse events
| Measure |
13vPnC Infant Series
n=299 participants at risk；n=300 participants at risk
Participants received one single 0.5mL dose of 13vPnC coadministered with Infanrix hexa at 2, 3, 4 months. Adverse events were collected from dose 1 to approximately one month after dose 3.
|
7vPnC Infant Series
n=300 participants at risk；n=303 participants at risk
Participants received one single 0.5mL dose of 7vPnC coadministered with Infanrix hexa at 2, 3, 4 months. Adverse events were collected from dose 1 to approximately one month after dose 3.
|
13vPnC Post-Infant Series
n=299 participants at risk；n=300 participants at risk
Participants received one single 0.5mL dose of 13vPnC coadministered with Infanrix hexa at 2, 3, 4 months. Adverse events were collected from approximately one month after dose 3 to toddler dose.
|
7vPnC Post-Infant Series
n=300 participants at risk；n=303 participants at risk
Participants received one single 0.5mL dose of 7vPnC coadministered with Infanrix hexa at 2, 3, 4 months (infant series) and 12 months of age (toddler dose). Adverse events were collected from approximately one month after dose 3 to toddler dose.
|
13vPnC Toddler Dose
n=289 participants at risk；n=300 participants at risk
Participants received one single 0.5mL dose of 13vPnC at 12 months of age. Adverse events were collected for approximately one month after toddler dose.
|
7vPnC Toddler Dose
n=284 participants at risk；n=303 participants at risk
Participants received one single 0.5mL dose of 7vPnC coadministered with Infanrix hexa at 12 months of age. Adverse events were collected for approximately one month after toddler dose.
|
13vPnC 6-Month Follow-up
n=287 participants at risk；n=300 participants at risk
Participants received one single 0.5mL dose of 13vPnC coadministered with Infanrix hexa at 2, 3, 4 months (infant series) and 12 months of age (toddler dose). Adverse events were collected for approximately six months after last visit.
|
7vPnC 6-Month Follow-up
n=287 participants at risk；n=303 participants at risk
Participants received one single 0.5mL dose of 7vPnC coadministered with Infanrix hexa at 2, 3, 4 months (infant series) and 12 months of age (toddler dose). Adverse events were collected for approximately six months after last visit.
|
|---|---|---|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Induration (Mild)
|
24.8%
56/226
|
27.8%
62/223
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
Skin and subcutaneous tissue disorders
Induration (Moderate)
|
6.9%
15/217
|
5.2%
11/211
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
Skin and subcutaneous tissue disorders
Induration (Severe)
|
0.00%
0/214
|
0.00%
0/208
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
Skin and subcutaneous tissue disorders
Erythema (Any)
|
34.9%
83/238
|
39.8%
92/231
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.67%
2/299
|
0.33%
1/300
|
0.00%
0/299
|
0.33%
1/300
|
0.35%
1/289
|
0.35%
1/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Blood and lymphatic system disorders
Anaemia
|
0.33%
1/299
|
0.33%
1/300
|
0.00%
0/299
|
0.00%
0/300
|
0.35%
1/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Congenital, familial and genetic disorders
Dacryostenosis congenital
|
0.00%
0/299
|
0.67%
2/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Congenital, familial and genetic disorders
Congenital torticollis
|
0.00%
0/299
|
0.33%
1/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Congenital, familial and genetic disorders
Craniotabes
|
0.33%
1/299
|
0.00%
0/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Congenital, familial and genetic disorders
Cryptorchism
|
0.00%
0/299
|
0.33%
1/300
|
0.00%
0/299
|
0.00%
0/300
|
0.35%
1/289
|
0.35%
1/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Congenital, familial and genetic disorders
Hereditary fructose intolerance
|
0.00%
0/299
|
0.33%
1/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Congenital, familial and genetic disorders
Macrocephaly
|
0.00%
0/299
|
0.33%
1/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Congenital, familial and genetic disorders
Naevus flammeus
|
0.00%
0/299
|
0.33%
1/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Congenital, familial and genetic disorders
Pectus excavatum
|
0.00%
0/299
|
0.33%
1/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Congenital, familial and genetic disorders
Plagiocephaly
|
0.33%
1/299
|
0.00%
0/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Ear and labyrinth disorders
Middle ear disorder
|
0.33%
1/299
|
0.33%
1/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/299
|
0.33%
1/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Ear and labyrinth disorders
Middle ear effusion
|
0.00%
0/299
|
0.33%
1/300
|
0.00%
0/299
|
0.00%
0/300
|
0.35%
1/289
|
0.35%
1/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Ear and labyrinth disorders
Otosalpingitis
|
0.00%
0/299
|
0.33%
1/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Eye disorders
Conjunctivitis
|
7.4%
22/299
|
8.3%
25/300
|
0.00%
0/299
|
0.00%
0/300
|
3.1%
9/289
|
2.1%
6/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Eye disorders
Dacryostenosis acquired
|
0.33%
1/299
|
0.67%
2/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Eye disorders
Pupils unequal
|
0.67%
2/299
|
0.00%
0/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Eye disorders
Dacryoadenitis acquired
|
0.33%
1/299
|
0.00%
0/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Eye disorders
Eye inflammation
|
0.00%
0/299
|
0.33%
1/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Gastrointestinal disorders
Diarrhoea
|
7.0%
21/299
|
4.7%
14/300
|
0.00%
0/299
|
0.00%
0/300
|
1.4%
4/289
|
2.8%
8/284
|
0.35%
1/287
|
0.00%
0/287
|
|
Gastrointestinal disorders
Flatulence
|
3.7%
11/299
|
2.7%
8/300
|
0.00%
0/299
|
0.00%
0/300
|
0.69%
2/289
|
0.35%
1/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Gastrointestinal disorders
Constipation
|
3.7%
11/299
|
2.0%
6/300
|
0.00%
0/299
|
0.00%
0/300
|
0.35%
1/289
|
0.70%
2/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Gastrointestinal disorders
Vomiting
|
2.7%
8/299
|
2.3%
7/300
|
0.00%
0/299
|
0.00%
0/300
|
1.0%
3/289
|
0.70%
2/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Gastrointestinal disorders
Teething
|
2.0%
6/299
|
2.7%
8/300
|
0.00%
0/299
|
0.67%
2/300
|
1.4%
4/289
|
1.1%
3/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Gastrointestinal disorders
Dyspepsia
|
1.7%
5/299
|
0.67%
2/300
|
0.00%
0/299
|
0.00%
0/300
|
0.69%
2/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Gastrointestinal disorders
Infantile colic
|
0.67%
2/299
|
0.33%
1/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Gastrointestinal disorders
Dental discomfort
|
0.33%
1/299
|
0.33%
1/300
|
0.00%
0/299
|
0.00%
0/300
|
0.35%
1/289
|
0.35%
1/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Gastrointestinal disorders
Anal prolapse
|
0.33%
1/299
|
0.00%
0/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.00%
0/299
|
0.33%
1/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.35%
1/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Gastrointestinal disorders
Enteritis
|
0.33%
1/299
|
0.00%
0/300
|
0.00%
0/299
|
0.00%
0/300
|
0.35%
1/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Gastrointestinal disorders
Stomatitis
|
0.33%
1/299
|
0.00%
0/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.70%
2/284
|
0.00%
0/287
|
0.00%
0/287
|
|
General disorders
Pyrexia
|
9.7%
29/299
|
9.0%
27/300
|
0.00%
0/299
|
0.00%
0/300
|
4.8%
14/289
|
9.9%
28/284
|
0.00%
0/287
|
0.00%
0/287
|
|
General disorders
Injection site swelling
|
1.0%
3/299
|
1.3%
4/300
|
0.00%
0/299
|
0.00%
0/300
|
1.0%
3/289
|
1.8%
5/284
|
0.00%
0/287
|
0.00%
0/287
|
|
General disorders
Injection site erythema
|
0.67%
2/299
|
0.67%
2/300
|
0.00%
0/299
|
0.00%
0/300
|
1.4%
4/289
|
1.8%
5/284
|
0.00%
0/287
|
0.00%
0/287
|
|
General disorders
Injection site induration
|
0.33%
1/299
|
1.0%
3/300
|
0.00%
0/299
|
0.00%
0/300
|
0.35%
1/289
|
1.4%
4/284
|
0.00%
0/287
|
0.00%
0/287
|
|
General disorders
Injection site pain
|
0.33%
1/299
|
0.33%
1/300
|
0.00%
0/299
|
0.00%
0/300
|
0.69%
2/289
|
1.4%
4/284
|
0.00%
0/287
|
0.00%
0/287
|
|
General disorders
Injection site reaction
|
0.67%
2/299
|
0.00%
0/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
General disorders
Injection site haematoma
|
0.33%
1/299
|
0.00%
0/300
|
0.00%
0/299
|
0.00%
0/300
|
0.35%
1/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
General disorders
Pain
|
0.00%
0/299
|
0.33%
1/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/299
|
0.33%
1/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Infections and infestations
Upper respiratory tract infection
|
25.1%
75/299
|
21.3%
64/300
|
0.67%
2/299
|
0.33%
1/300
|
13.8%
40/289
|
11.3%
32/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Infections and infestations
Bronchitis
|
16.4%
49/299
|
15.0%
45/300
|
0.67%
2/299
|
0.67%
2/300
|
6.9%
20/289
|
6.7%
19/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Infections and infestations
Rhinitis
|
8.0%
24/299
|
10.7%
32/300
|
0.67%
2/299
|
0.00%
0/300
|
5.5%
16/289
|
4.6%
13/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Infections and infestations
Nasopharyngitis
|
6.4%
19/299
|
9.3%
28/300
|
0.00%
0/299
|
0.33%
1/300
|
3.5%
10/289
|
4.9%
14/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Infections and infestations
Gastroenteritis
|
7.0%
21/299
|
7.3%
22/300
|
0.00%
0/299
|
0.00%
0/300
|
5.5%
16/289
|
3.9%
11/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Infections and infestations
Viral infection
|
3.7%
11/299
|
4.7%
14/300
|
0.00%
0/299
|
0.00%
0/300
|
1.7%
5/289
|
2.8%
8/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Infections and infestations
Oral candidiasis
|
3.0%
9/299
|
4.0%
12/300
|
0.00%
0/299
|
0.33%
1/300
|
0.35%
1/289
|
1.1%
3/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Infections and infestations
Otitis media
|
2.3%
7/299
|
4.3%
13/300
|
0.00%
0/299
|
0.00%
0/300
|
4.2%
12/289
|
3.5%
10/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Infections and infestations
Febrile infection
|
2.3%
7/299
|
3.3%
10/300
|
0.00%
0/299
|
0.33%
1/300
|
2.4%
7/289
|
1.8%
5/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Infections and infestations
Candida nappy rash
|
1.3%
4/299
|
1.7%
5/300
|
0.00%
0/299
|
0.33%
1/300
|
0.69%
2/289
|
0.35%
1/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Infections and infestations
Respiratory tract infection
|
2.0%
6/299
|
1.0%
3/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.35%
1/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Infections and infestations
Enteritis infectious
|
1.0%
3/299
|
1.7%
5/300
|
0.00%
0/299
|
0.00%
0/300
|
0.35%
1/289
|
0.35%
1/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Infections and infestations
Exanthema subitum
|
1.3%
4/299
|
1.3%
4/300
|
0.00%
0/299
|
0.00%
0/300
|
1.0%
3/289
|
0.35%
1/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Infections and infestations
Influenza
|
0.67%
2/299
|
1.3%
4/300
|
0.00%
0/299
|
0.00%
0/300
|
0.35%
1/289
|
0.35%
1/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Infections and infestations
Candidiasis
|
0.67%
2/299
|
1.0%
3/300
|
0.00%
0/299
|
0.00%
0/300
|
0.35%
1/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Infections and infestations
Ear infection
|
1.0%
3/299
|
0.33%
1/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Infections and infestations
Pharyngitis
|
0.67%
2/299
|
0.33%
1/300
|
0.00%
0/299
|
0.00%
0/300
|
0.35%
1/289
|
1.1%
3/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Infections and infestations
Skin candida
|
0.00%
0/299
|
1.0%
3/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.70%
2/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Infections and infestations
Varicella
|
1.0%
3/299
|
0.00%
0/300
|
0.00%
0/299
|
0.33%
1/300
|
0.00%
0/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Infections and infestations
Bacterial infection
|
0.67%
2/299
|
0.00%
0/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Infections and infestations
Bronchiolitis
|
0.67%
2/299
|
0.00%
0/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Infections and infestations
Genital candidiasis
|
0.33%
1/299
|
0.33%
1/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Infections and infestations
Oral fungal infection
|
0.33%
1/299
|
0.33%
1/300
|
0.00%
0/299
|
0.00%
0/300
|
0.35%
1/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Infections and infestations
Paronychia
|
0.33%
1/299
|
0.33%
1/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.35%
1/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/299
|
0.67%
2/300
|
0.00%
0/299
|
0.00%
0/300
|
0.35%
1/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Infections and infestations
Viral rash
|
0.67%
2/299
|
0.00%
0/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.33%
1/299
|
0.33%
1/300
|
0.00%
0/299
|
0.00%
0/300
|
0.35%
1/289
|
0.35%
1/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Infections and infestations
Abscess
|
0.33%
1/299
|
0.00%
0/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Infections and infestations
Bacterial rhinitis
|
0.00%
0/299
|
0.33%
1/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Infections and infestations
Bronchitis bacterial
|
0.00%
0/299
|
0.33%
1/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Infections and infestations
Conjunctivitis infective
|
0.33%
1/299
|
0.00%
0/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Infections and infestations
Croup infectious
|
0.33%
1/299
|
0.00%
0/300
|
0.00%
0/299
|
0.00%
0/300
|
0.69%
2/289
|
1.1%
3/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Infections and infestations
Eczema infected
|
0.00%
0/299
|
0.33%
1/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Infections and infestations
Folliculitis
|
0.00%
0/299
|
0.33%
1/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Infections and infestations
Fungal skin infection
|
0.33%
1/299
|
0.00%
0/300
|
0.00%
0/299
|
0.00%
0/300
|
0.35%
1/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Infections and infestations
Gastrointestinal infection
|
0.33%
1/299
|
0.00%
0/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Infections and infestations
Infection
|
0.33%
1/299
|
0.00%
0/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.35%
1/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/299
|
0.33%
1/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.35%
1/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Infections and infestations
Otitis media viral
|
0.33%
1/299
|
0.00%
0/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Infections and infestations
Pertussis
|
0.00%
0/299
|
0.33%
1/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Infections and infestations
Pneumonia
|
0.33%
1/299
|
0.00%
0/300
|
0.00%
0/299
|
0.00%
0/300
|
0.35%
1/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Infections and infestations
Postoperative wound infection
|
0.33%
1/299
|
0.00%
0/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Infections and infestations
Pseudocroup
|
0.00%
0/299
|
0.33%
1/300
|
0.00%
0/299
|
0.00%
0/300
|
0.35%
1/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Infections and infestations
Scarlet fever
|
0.33%
1/299
|
0.00%
0/300
|
0.00%
0/299
|
0.00%
0/300
|
0.35%
1/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Infections and infestations
Sinobronchitis
|
0.00%
0/299
|
0.33%
1/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Infections and infestations
Tinea infection
|
0.33%
1/299
|
0.00%
0/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.35%
1/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/299
|
0.33%
1/300
|
0.00%
0/299
|
0.00%
0/300
|
0.69%
2/289
|
0.35%
1/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Infections and infestations
Tonsillitis streptococcal
|
0.00%
0/299
|
0.33%
1/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Infections and infestations
Tracheitis
|
0.00%
0/299
|
0.33%
1/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.35%
1/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/299
|
0.33%
1/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Infections and infestations
Viral diarrhoea
|
0.00%
0/299
|
0.33%
1/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Infections and infestations
Viral rhinitis
|
0.00%
0/299
|
0.33%
1/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Injury, poisoning and procedural complications
Contusion
|
1.0%
3/299
|
0.67%
2/300
|
0.00%
0/299
|
0.00%
0/300
|
0.35%
1/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.33%
1/299
|
0.67%
2/300
|
0.33%
1/299
|
0.00%
0/300
|
0.35%
1/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.33%
1/299
|
0.00%
0/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.33%
1/299
|
0.00%
0/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/299
|
0.33%
1/300
|
0.00%
0/299
|
0.00%
0/300
|
0.35%
1/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/299
|
0.33%
1/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.35%
1/284
|
0.35%
1/287
|
0.00%
0/287
|
|
Investigations
Weight decreased
|
0.00%
0/299
|
0.33%
1/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.33%
1/299
|
0.67%
2/300
|
0.00%
0/299
|
0.00%
0/300
|
0.35%
1/289
|
0.70%
2/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Metabolism and nutrition disorders
Feeding disorder neonatal
|
0.33%
1/299
|
0.33%
1/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.00%
0/284
|
0.35%
1/287
|
0.00%
0/287
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/299
|
0.33%
1/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/299
|
0.33%
1/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/299
|
0.33%
1/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/299
|
0.33%
1/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Metabolism and nutrition disorders
Oral intake reduced
|
0.33%
1/299
|
0.00%
0/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Musculoskeletal and connective tissue disorders
Posture abnormal
|
0.67%
2/299
|
0.00%
0/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.00%
0/299
|
0.33%
1/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.00%
0/299
|
0.33%
1/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Musculoskeletal and connective tissue disorders
Head deformity
|
0.00%
0/299
|
0.33%
1/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Musculoskeletal and connective tissue disorders
Hypotonia neonatal
|
0.00%
0/299
|
0.33%
1/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma
|
0.33%
1/299
|
0.33%
1/300
|
0.00%
0/299
|
0.00%
0/300
|
0.35%
1/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.00%
0/299
|
0.33%
1/300
|
0.00%
0/299
|
0.33%
1/300
|
0.00%
0/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Nervous system disorders
Coordination abnormal
|
1.0%
3/299
|
2.3%
7/300
|
0.00%
0/299
|
0.33%
1/300
|
0.00%
0/289
|
0.70%
2/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Nervous system disorders
Hypotonia
|
0.33%
1/299
|
1.0%
3/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Nervous system disorders
Hypersomnia
|
1.0%
3/299
|
0.00%
0/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.35%
1/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Nervous system disorders
Hypertonia
|
0.33%
1/299
|
0.33%
1/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Nervous system disorders
Hypokinesia
|
0.00%
0/299
|
0.67%
2/300
|
0.00%
0/299
|
0.67%
2/300
|
0.00%
0/289
|
0.35%
1/284
|
0.00%
0/287
|
0.35%
1/287
|
|
Nervous system disorders
High-pitched crying
|
0.00%
0/299
|
0.33%
1/300
|
0.00%
0/299
|
0.00%
0/300
|
0.35%
1/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Nervous system disorders
Myotonia
|
0.00%
0/299
|
0.33%
1/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Nervous system disorders
Poor quality sleep
|
0.00%
0/299
|
0.33%
1/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Nervous system disorders
Somnolence
|
0.33%
1/299
|
0.00%
0/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Psychiatric disorders
Crying
|
3.7%
11/299
|
3.3%
10/300
|
0.00%
0/299
|
0.00%
0/300
|
0.35%
1/289
|
0.70%
2/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Psychiatric disorders
Restlessness
|
2.3%
7/299
|
4.7%
14/300
|
0.00%
0/299
|
0.00%
0/300
|
1.0%
3/289
|
0.35%
1/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Psychiatric disorders
Agitation
|
0.33%
1/299
|
0.00%
0/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Psychiatric disorders
Insomnia
|
0.33%
1/299
|
0.00%
0/300
|
0.00%
0/299
|
0.00%
0/300
|
1.0%
3/289
|
1.1%
3/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Renal and urinary disorders
Ureteric stenosis
|
0.00%
0/299
|
0.33%
1/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Renal and urinary disorders
Vesicoureteric reflux
|
0.33%
1/299
|
0.00%
0/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Reproductive system and breast disorders
Vulval disorder
|
1.7%
5/299
|
2.3%
7/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.35%
1/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.0%
12/299
|
2.3%
7/300
|
0.00%
0/299
|
0.00%
0/300
|
2.4%
7/289
|
1.1%
3/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.33%
1/299
|
0.00%
0/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.00%
0/284
|
0.35%
1/287
|
0.35%
1/287
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.33%
1/299
|
0.00%
0/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.33%
1/299
|
0.00%
0/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.35%
1/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.33%
1/299
|
0.00%
0/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/299
|
0.33%
1/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
0.00%
0/299
|
0.33%
1/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Respiratory, thoracic and mediastinal disorders
Supraclavicular retraction
|
0.33%
1/299
|
0.00%
0/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.33%
1/299
|
0.00%
0/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
7.4%
22/299
|
8.3%
25/300
|
0.00%
0/299
|
0.33%
1/300
|
5.9%
17/289
|
5.6%
16/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Skin and subcutaneous tissue disorders
Eczema
|
3.3%
10/299
|
4.7%
14/300
|
0.67%
2/299
|
0.00%
0/300
|
1.0%
3/289
|
1.8%
5/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Skin and subcutaneous tissue disorders
Eczema infantile
|
2.0%
6/299
|
2.0%
6/300
|
0.33%
1/299
|
0.00%
0/300
|
1.0%
3/289
|
0.35%
1/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
2.3%
7/299
|
1.7%
5/300
|
0.00%
0/299
|
0.67%
2/300
|
1.0%
3/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.3%
4/299
|
1.7%
5/300
|
0.00%
0/299
|
0.00%
0/300
|
0.35%
1/289
|
1.1%
3/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Skin and subcutaneous tissue disorders
Eczema asteatotic
|
1.0%
3/299
|
1.3%
4/300
|
0.00%
0/299
|
0.00%
0/300
|
0.69%
2/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Skin and subcutaneous tissue disorders
Intertrigo
|
0.33%
1/299
|
1.7%
5/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.35%
1/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.67%
2/299
|
1.0%
3/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.35%
1/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.33%
1/299
|
1.0%
3/300
|
0.00%
0/299
|
0.00%
0/300
|
1.0%
3/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Skin and subcutaneous tissue disorders
Neurodermatitis
|
1.0%
3/299
|
0.00%
0/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.00%
0/284
|
0.35%
1/287
|
0.00%
0/287
|
|
Skin and subcutaneous tissue disorders
Heat rash
|
0.00%
0/299
|
0.67%
2/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.33%
1/299
|
0.00%
0/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.35%
1/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.33%
1/299
|
0.00%
0/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Skin and subcutaneous tissue disorders
Hirsutism
|
0.33%
1/299
|
0.00%
0/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.33%
1/299
|
0.00%
0/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.33%
1/299
|
0.00%
0/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/299
|
0.33%
1/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Skin and subcutaneous tissue disorders
Rash neonatal
|
0.00%
0/299
|
0.33%
1/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/299
|
0.33%
1/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.33%
1/299
|
0.00%
0/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
0.00%
0/299
|
0.33%
1/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/299
|
0.33%
1/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Skin and subcutaneous tissue disorders
Vitiligo
|
0.00%
0/299
|
0.33%
1/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Blood and lymphatic system disorders
Mastocytosis
|
0.00%
0/299
|
0.00%
0/300
|
0.33%
1/299
|
0.00%
0/300
|
0.00%
0/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Eye disorders
Eyelid disorder
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/299
|
0.33%
1/300
|
0.00%
0/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Immune system disorders
Atopy
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/299
|
0.33%
1/300
|
0.00%
0/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Infections and infestations
Salmonellosis
|
0.00%
0/299
|
0.00%
0/300
|
0.33%
1/299
|
0.00%
0/300
|
0.00%
0/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/299
|
0.67%
2/300
|
0.00%
0/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/299
|
0.00%
0/300
|
0.35%
1/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/299
|
0.00%
0/300
|
0.35%
1/289
|
0.35%
1/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/299
|
0.00%
0/300
|
0.35%
1/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
General disorders
Irritability
|
45.4%
108/238
|
48.9%
115/235
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
General disorders
Granuloma
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/299
|
0.00%
0/300
|
0.35%
1/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Infections and infestations
Acute tonsillitis
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/299
|
0.00%
0/300
|
0.69%
2/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Infections and infestations
Bronchitis viral
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.35%
1/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/299
|
0.00%
0/300
|
0.35%
1/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Infections and infestations
Fungal infection
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.35%
1/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/299
|
0.00%
0/300
|
0.35%
1/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.35%
1/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Infections and infestations
Herpes virus infection
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.35%
1/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/299
|
0.00%
0/300
|
0.35%
1/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Infections and infestations
Omphalitis
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.35%
1/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Infections and infestations
Otitis externa
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/299
|
0.00%
0/300
|
0.35%
1/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Infections and infestations
Rhinolaryngitis
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/299
|
0.00%
0/300
|
0.35%
1/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Infections and infestations
Rotavirus infection
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.35%
1/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Infections and infestations
Tracheobronchitis
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/299
|
0.00%
0/300
|
0.35%
1/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Infections and infestations
Viral skin infection
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.35%
1/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Injury, poisoning and procedural complications
Skeletal injury
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/299
|
0.00%
0/300
|
0.69%
2/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Injury, poisoning and procedural complications
Accidental exposure
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.35%
1/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/299
|
0.00%
0/300
|
0.35%
1/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.35%
1/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Injury, poisoning and procedural complications
Mouth injury
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.35%
1/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/299
|
0.00%
0/300
|
0.35%
1/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/299
|
0.00%
0/300
|
0.35%
1/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Metabolism and nutrition disorders
Weight gain poor
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/299
|
0.00%
0/300
|
0.35%
1/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/299
|
0.00%
0/300
|
0.35%
1/289
|
0.35%
1/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/299
|
0.00%
0/300
|
0.35%
1/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Nervous system disorders
Fine motor delay
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.35%
1/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Nervous system disorders
Pseudoparalysis
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.35%
1/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Psychiatric disorders
Screaming
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/299
|
0.00%
0/300
|
0.35%
1/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Renal and urinary disorders
Urinary tract disorder
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/299
|
0.00%
0/300
|
0.35%
1/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Reproductive system and breast disorders
Balanitis
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.35%
1/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/299
|
0.00%
0/300
|
0.35%
1/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.35%
1/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.35%
1/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Skin and subcutaneous tissue disorders
Xeroderma
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/299
|
0.00%
0/300
|
0.35%
1/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Congenital, familial and genetic disorders
21-hydroxylase deficiency
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.00%
0/284
|
0.35%
1/287
|
0.00%
0/287
|
|
Eye disorders
Strabismus
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.00%
0/284
|
0.00%
0/287
|
0.35%
1/287
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.00%
0/284
|
0.00%
0/287
|
0.35%
1/287
|
|
Investigations
Cardiac murmur
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.00%
0/284
|
0.35%
1/287
|
0.35%
1/287
|
|
Investigations
Blood immunoglobulin e increased
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.00%
0/284
|
0.35%
1/287
|
0.00%
0/287
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar disorder
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.00%
0/284
|
0.35%
1/287
|
0.00%
0/287
|
|
Eye disorders
Hypermetropia
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/299
|
0.33%
1/300
|
0.00%
0/289
|
0.00%
0/284
|
0.35%
1/287
|
0.00%
0/287
|
|
General disorders
Developmental delay
|
0.00%
0/299
|
0.00%
0/300
|
0.33%
1/299
|
0.33%
1/300
|
0.35%
1/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Infections and infestations
Wound infection
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/299
|
0.33%
1/300
|
0.00%
0/289
|
0.35%
1/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/299
|
0.00%
0/300
|
0.33%
1/299
|
0.00%
0/300
|
1.0%
3/289
|
0.00%
0/284
|
0.00%
0/287
|
0.00%
0/287
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/299
|
0.67%
2/300
|
0.00%
0/289
|
0.00%
0/284
|
0.35%
1/287
|
0.35%
1/287
|
|
Immune system disorders
Food allergy
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/299
|
0.00%
0/300
|
0.35%
1/289
|
0.00%
0/284
|
0.00%
0/287
|
0.35%
1/287
|
|
Metabolism and nutrition disorders
Hyperphosphatasaemia
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/299
|
0.00%
0/300
|
0.00%
0/289
|
0.35%
1/284
|
0.00%
0/287
|
0.35%
1/287
|
|
Skin and subcutaneous tissue disorders
Tenderness (Any)
|
27.1%
62/229
|
21.3%
47/221
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
Skin and subcutaneous tissue disorders
Tenderness (Significant)
|
4.2%
9/215
|
2.9%
6/209
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
Skin and subcutaneous tissue disorders
Induration (Any)
|
26.1%
59/226
|
28.6%
64/224
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
Skin and subcutaneous tissue disorders
Erythema (Mild)
|
34.2%
81/237
|
38.9%
89/229
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
Skin and subcutaneous tissue disorders
Erythema (Moderate)
|
4.6%
10/217
|
2.4%
5/210
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
Skin and subcutaneous tissue disorders
Erythema (Severe)
|
0.00%
0/214
|
0.00%
0/208
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
General disorders
Fever ≥38°C but ≤39°C
|
46.3%
112/242
|
36.6%
85/232
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
General disorders
Fever >39°C but ≤40°C
|
3.7%
8/216
|
1.4%
3/210
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
General disorders
Fever >40°C
|
0.93%
2/216
|
0.00%
0/209
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
General disorders
Decreased appetite
|
33.1%
78/236
|
30.2%
68/225
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
General disorders
Increased sleep
|
49.6%
119/240
|
49.4%
119/241
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
General disorders
Decreased sleep
|
20.9%
48/230
|
24.4%
54/221
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
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