Trial Outcomes & Findings for Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants (NCT NCT00366548)
NCT ID: NCT00366548
Last Updated: 2012-08-15
Results Overview
Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥0.35μg/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
500 participants
Primary outcome timeframe
One month after 3-dose infant series (at 5 months of age)
Results posted on
2012-08-15
Participant Flow
Participants were recruited in Poland from November 2006 to December 2006.
Participants were enrolled into the study according to inclusion/exclusion criteria without a screening period.
Participant milestones
| Measure |
13vPnC With (+) Polysorbate 80
Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) with (+) P80 coadministered with combination vaccine containing diphtheria, tetanus, acellular pertussis, inactivated poliovirus, and conjugated Hib antigens (Pentaxim) and hepatitis B recombinant vaccine adsorbed (Engerix-B) at approximately 2 months of age, Pentaxim at approximately 3 months and 4 months of age (infant series), and combined vaccine containing attenuated measles, mumps, and rubella viruses (Priorix) at 12 months of age (toddler dose).
|
13vPnC Without (-) Polysorbate 80
Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) without (-) P80 coadministered with combination vaccine containing diphtheria, tetanus, acellular pertussis, inactivated poliovirus, and conjugated Hib antigens (Pentaxim) and hepatitis B recombinant vaccine adsorbed (Engerix-B) at approximately 2 months of age, Pentaxim at approximately 3 months and 4 months of age (infant series), and combined vaccine containing attenuated measles, mumps, and rubella viruses (Priorix) at 12 months of age (toddler dose).
|
|---|---|---|
|
Infant Series
STARTED
|
250
|
250
|
|
Infant Series
Vaccinated Dose 1
|
250
|
250
|
|
Infant Series
Vaccinated Dose 2
|
246
|
249
|
|
Infant Series
Vaccinated Dose 3
|
246
|
247
|
|
Infant Series
COMPLETED
|
246
|
245
|
|
Infant Series
NOT COMPLETED
|
4
|
5
|
|
After Infant Series
STARTED
|
246
|
245
|
|
After Infant Series
COMPLETED
|
240
|
244
|
|
After Infant Series
NOT COMPLETED
|
6
|
1
|
|
Toddler Dose
STARTED
|
240
|
244
|
|
Toddler Dose
COMPLETED
|
240
|
244
|
|
Toddler Dose
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
13vPnC With (+) Polysorbate 80
Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) with (+) P80 coadministered with combination vaccine containing diphtheria, tetanus, acellular pertussis, inactivated poliovirus, and conjugated Hib antigens (Pentaxim) and hepatitis B recombinant vaccine adsorbed (Engerix-B) at approximately 2 months of age, Pentaxim at approximately 3 months and 4 months of age (infant series), and combined vaccine containing attenuated measles, mumps, and rubella viruses (Priorix) at 12 months of age (toddler dose).
|
13vPnC Without (-) Polysorbate 80
Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) without (-) P80 coadministered with combination vaccine containing diphtheria, tetanus, acellular pertussis, inactivated poliovirus, and conjugated Hib antigens (Pentaxim) and hepatitis B recombinant vaccine adsorbed (Engerix-B) at approximately 2 months of age, Pentaxim at approximately 3 months and 4 months of age (infant series), and combined vaccine containing attenuated measles, mumps, and rubella viruses (Priorix) at 12 months of age (toddler dose).
|
|---|---|---|
|
Infant Series
Adverse Event
|
1
|
3
|
|
Infant Series
Protocol Violation
|
0
|
1
|
|
Infant Series
Withdrawal by Subject
|
3
|
1
|
|
After Infant Series
Withdrawal by Subject
|
3
|
1
|
|
After Infant Series
Adverse Event
|
2
|
0
|
|
After Infant Series
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants
Baseline characteristics by cohort
| Measure |
13vPnC With (+) Polysorbate 80
n=250 Participants
Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) with (+) P80 coadministered with combination vaccine containing diphtheria, tetanus, acellular pertussis, inactivated poliovirus, and conjugated Hib antigens (Pentaxim) and hepatitis B recombinant vaccine adsorbed (Engerix-B) at approximately 2 months of age, Pentaxim at approximately 3 months and 4 months of age (infant series), and combined vaccine containing attenuated measles, mumps, and rubella viruses (Priorix) at 12 months of age (toddler dose).
|
13vPnC Without (-) Polysorbate 80
n=250 Participants
Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) without (-) P80 coadministered with combination vaccine containing diphtheria, tetanus, acellular pertussis, inactivated poliovirus, and conjugated Hib antigens (Pentaxim) and hepatitis B recombinant vaccine adsorbed (Engerix-B) at approximately 2 months of age, Pentaxim at approximately 3 months and 4 months of age (infant series), and combined vaccine containing attenuated measles, mumps, and rubella viruses (Priorix) at 12 months of age (toddler dose).
|
Total
n=500 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
2.1 months
STANDARD_DEVIATION 0.5 • n=5 Participants
|
2.1 months
STANDARD_DEVIATION 0.5 • n=7 Participants
|
2.1 months
STANDARD_DEVIATION 0.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
122 Participants
n=5 Participants
|
122 Participants
n=7 Participants
|
244 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
128 Participants
n=5 Participants
|
128 Participants
n=7 Participants
|
256 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: One month after 3-dose infant series (at 5 months of age)Population: Evaluable immunogenicity population had valid and determinate assay results, and had no other major protocol violations, (n) = number of participants with a determinate immunoglobulin G (IgG) antibody concentration to the given serotype.
Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥0.35μg/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 + Polysorbate 80 After the Infant Series
n=238 Participants
Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
|
13vPnC - Polysorbate 80 After the Infant Series
n=238 Participants
Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
|
13vPnC + P80 Dose 2 Infant Series
Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 months age (infant series, Dose 2).
|
13vPnC - P80 Dose 2 Infant Series
Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 months age (infant series, Dose 2).
|
13vPnC + P80 Dose 3 Infant Series
Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant series, Dose 3).
|
13vPnC - P80 Dose 3 Infant Series
Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant series, Dose 3).
|
13vPnC + P80 Toddler Dose
Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant series), and Priorix at 12 months of age (toddler dose).
|
13vPnC - P80 Toddler Dose
Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant series), and Priorix at 12 months of age (toddler dose).
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC+P80 Group Relative to 13vPnC-80 Group After the Infant Series
Common Serotypes - Serotype 6B (n=145,158)
|
60.9 percentage of participants
Interval 54.4 to 67.2
|
66.4 percentage of participants
Interval 60.0 to 72.4
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC+P80 Group Relative to 13vPnC-80 Group After the Infant Series
Common Serotypes - Serotype 9V (n=231,232)
|
97.1 percentage of participants
Interval 94.0 to 98.8
|
97.5 percentage of participants
Interval 94.6 to 99.1
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC+P80 Group Relative to 13vPnC-80 Group After the Infant Series
Common Serotypes - Serotype 14 (n=225,232)
|
94.5 percentage of participants
Interval 90.8 to 97.1
|
97.5 percentage of participants
Interval 94.6 to 99.1
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC+P80 Group Relative to 13vPnC-80 Group After the Infant Series
Common Serotypes - Serotype 18C (n=233,233)
|
97.9 percentage of participants
Interval 95.2 to 99.3
|
97.9 percentage of participants
Interval 95.2 to 99.3
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC+P80 Group Relative to 13vPnC-80 Group After the Infant Series
Common Serotypes - Serotype 19F (n=228,234)
|
95.8 percentage of participants
Interval 92.4 to 98.0
|
98.3 percentage of participants
Interval 95.8 to 99.5
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC+P80 Group Relative to 13vPnC-80 Group After the Infant Series
Common Serotypes - Serotype 23F (n=205,220)
|
86.1 percentage of participants
Interval 81.1 to 90.3
|
92.4 percentage of participants
Interval 88.3 to 95.5
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC+P80 Group Relative to 13vPnC-80 Group After the Infant Series
Additional Serotypes - Serotype 1 (n=228,220)
|
95.8 percentage of participants
Interval 92.4 to 98.0
|
92.4 percentage of participants
Interval 88.3 to 95.5
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC+P80 Group Relative to 13vPnC-80 Group After the Infant Series
Additional Serotypes - Serotype 3 (n=233,236)
|
97.9 percentage of participants
Interval 95.2 to 99.3
|
99.2 percentage of participants
Interval 97.0 to 99.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC+P80 Group Relative to 13vPnC-80 Group After the Infant Series
Additional Serotypes - Serotype 5 (n=224,220)
|
94.1 percentage of participants
Interval 90.3 to 96.7
|
92.4 percentage of participants
Interval 88.3 to 95.5
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC+P80 Group Relative to 13vPnC-80 Group After the Infant Series
Additional Serotypes - Serotype 6A (n=206,205)
|
86.6 percentage of participants
Interval 81.6 to 90.6
|
86.1 percentage of participants
Interval 81.1 to 90.3
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC+P80 Group Relative to 13vPnC-80 Group After the Infant Series
Additional Serotypes - Serotype 7F (n=235,237)
|
98.7 percentage of participants
Interval 96.4 to 99.7
|
99.6 percentage of participants
Interval 97.7 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC+P80 Group Relative to 13vPnC-80 Group After the Infant Series
Additional Serotypes - Serotype 19A (n=235,238)
|
98.7 percentage of participants
Interval 96.4 to 99.7
|
100.0 percentage of participants
Interval 98.5 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC+P80 Group Relative to 13vPnC-80 Group After the Infant Series
Common Serotypes - Serotype 4 (n=222,224)
|
93.3 percentage of participants
Interval 89.3 to 96.1
|
94.1 percentage of participants
Interval 90.3 to 96.7
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: One month after 3-dose infant series (at 5 months of age)Population: Evaluable immunogenicity population 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 serotype.
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.
Outcome measures
| Measure |
13vPnC + Polysorbate 80 After the Infant Series
n=238 Participants
Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
|
13vPnC - Polysorbate 80 After the Infant Series
n=238 Participants
Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
|
13vPnC + P80 Dose 2 Infant Series
Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 months age (infant series, Dose 2).
|
13vPnC - P80 Dose 2 Infant Series
Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 months age (infant series, Dose 2).
|
13vPnC + P80 Dose 3 Infant Series
Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant series, Dose 3).
|
13vPnC - P80 Dose 3 Infant Series
Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant series, Dose 3).
|
13vPnC + P80 Toddler Dose
Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant series), and Priorix at 12 months of age (toddler dose).
|
13vPnC - P80 Toddler Dose
Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant series), and Priorix at 12 months of age (toddler dose).
|
|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Antibody Concentration (GMC) in 13vPnC+P80 Group Relative to 13vPnC-P80 Group After the 3-Dose Infant Series
Common Serotypes - Serotype 4
|
1.47 μg/mL
Interval 1.3 to 1.65
|
1.53 μg/mL
Interval 1.36 to 1.72
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration (GMC) in 13vPnC+P80 Group Relative to 13vPnC-P80 Group After the 3-Dose Infant Series
Common Serotypes - Serotype 6B
|
0.51 μg/mL
Interval 0.44 to 0.6
|
0.57 μg/mL
Interval 0.48 to 0.68
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration (GMC) in 13vPnC+P80 Group Relative to 13vPnC-P80 Group After the 3-Dose Infant Series
Common Serotypes - Serotype 9V
|
1.46 μg/mL
Interval 1.34 to 1.6
|
1.51 μg/mL
Interval 1.38 to 1.65
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration (GMC) in 13vPnC+P80 Group Relative to 13vPnC-P80 Group After the 3-Dose Infant Series
Common Serotypes - Serotype 14
|
2.37 μg/mL
Interval 2.06 to 2.73
|
2.48 μg/mL
Interval 2.2 to 2.8
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration (GMC) in 13vPnC+P80 Group Relative to 13vPnC-P80 Group After the 3-Dose Infant Series
Common Serotypes - Serotype 18C
|
1.84 μg/mL
Interval 1.67 to 2.03
|
1.87 μg/mL
Interval 1.71 to 2.04
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration (GMC) in 13vPnC+P80 Group Relative to 13vPnC-P80 Group After the 3-Dose Infant Series
Common Serotypes - Serotype 19F
|
1.46 μg/mL
Interval 1.3 to 1.65
|
1.75 μg/mL
Interval 1.6 to 1.91
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration (GMC) in 13vPnC+P80 Group Relative to 13vPnC-P80 Group After the 3-Dose Infant Series
Common Serotypes - Serotype 23F
|
0.93 μg/mL
Interval 0.83 to 1.05
|
1.11 μg/mL
Interval 1.0 to 1.24
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration (GMC) in 13vPnC+P80 Group Relative to 13vPnC-P80 Group After the 3-Dose Infant Series
Additional Serotypes - Serotype 1
|
1.39 μg/mL
Interval 1.26 to 1.55
|
1.48 μg/mL
Interval 1.32 to 1.66
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration (GMC) in 13vPnC+P80 Group Relative to 13vPnC-P80 Group After the 3-Dose Infant Series
Additional Serotypes - Serotype 3
|
1.50 μg/mL
Interval 1.38 to 1.63
|
1.62 μg/mL
Interval 1.49 to 1.75
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration (GMC) in 13vPnC+P80 Group Relative to 13vPnC-P80 Group After the 3-Dose Infant Series
Additional Serotypes - Serotype 5
|
1.26 μg/mL
Interval 1.13 to 1.4
|
1.30 μg/mL
Interval 1.16 to 1.44
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration (GMC) in 13vPnC+P80 Group Relative to 13vPnC-P80 Group After the 3-Dose Infant Series
Additional Serotypes - Serotype 6A
|
0.99 μg/mL
Interval 0.88 to 1.12
|
1.04 μg/mL
Interval 0.92 to 1.17
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration (GMC) in 13vPnC+P80 Group Relative to 13vPnC-P80 Group After the 3-Dose Infant Series
Additional Serotypes - Serotype 7F
|
1.98 μg/mL
Interval 1.81 to 2.15
|
1.89 μg/mL
Interval 1.73 to 2.06
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration (GMC) in 13vPnC+P80 Group Relative to 13vPnC-P80 Group After the 3-Dose Infant Series
Additional Serotypes - Serotype 19A
|
2.68 μg/mL
Interval 2.44 to 2.95
|
2.94 μg/mL
Interval 2.69 to 3.21
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: one month after the toddler dose (at 13 months of age)Population: Evaluable immunogenicity population had valid and determinate assay results, and had no other major protocol violations, (n) = number of participants with a determinate IgG antibody concentration to the given serotype.
Percentages 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 + Polysorbate 80 After the Infant Series
n=227 Participants
Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
|
13vPnC - Polysorbate 80 After the Infant Series
n=238 Participants
Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
|
13vPnC + P80 Dose 2 Infant Series
Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 months age (infant series, Dose 2).
|
13vPnC - P80 Dose 2 Infant Series
Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 months age (infant series, Dose 2).
|
13vPnC + P80 Dose 3 Infant Series
Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant series, Dose 3).
|
13vPnC - P80 Dose 3 Infant Series
Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant series, Dose 3).
|
13vPnC + P80 Toddler Dose
Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant series), and Priorix at 12 months of age (toddler dose).
|
13vPnC - P80 Toddler Dose
Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant series), and Priorix at 12 months of age (toddler dose).
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the Toddler Dose
Additional Serotypes - Serotype 19A (n=226,238)
|
100.0 percentage of participants
Interval 98.4 to 100.0
|
100.0 percentage of participants
Interval 98.5 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the Toddler Dose
Common Serotypes - Serotype 4 (n=226,238)
|
99.6 percentage of participants
Interval 97.6 to 100.0
|
99.6 percentage of participants
Interval 97.7 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the Toddler Dose
Common Serotypes - Serotype 6B (n=225,237)
|
99.6 percentage of participants
Interval 97.5 to 100.0
|
99.2 percentage of participants
Interval 97.0 to 99.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the Toddler Dose
Common Serotypes - Serotype 9V (n=226,238)
|
99.6 percentage of participants
Interval 97.6 to 100.0
|
100.0 percentage of participants
Interval 98.5 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the Toddler Dose
Common Serotypes - Serotype 14 (n=226,238)
|
99.6 percentage of participants
Interval 97.6 to 100.0
|
99.6 percentage of participants
Interval 97.7 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the Toddler Dose
Common Serotypes - Serotype 18C (n=226,238)
|
100.0 percentage of participants
Interval 98.4 to 100.0
|
99.6 percentage of participants
Interval 97.7 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the Toddler Dose
Common Serotypes - Serotype 19F (n=226,237)
|
99.1 percentage of participants
Interval 96.8 to 99.9
|
98.7 percentage of participants
Interval 96.3 to 99.7
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the Toddler Dose
Common Serotypes - Serotype 23F (n=226,238)
|
98.7 percentage of participants
Interval 96.2 to 99.7
|
99.6 percentage of participants
Interval 97.7 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the Toddler Dose
Additional Serotypes - Serotype 1 (n=226,238)
|
100.0 percentage of participants
Interval 98.4 to 100.0
|
99.2 percentage of participants
Interval 97.0 to 99.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the Toddler Dose
Additional Serotypes - Serotype 3 (n=223,236)
|
95.1 percentage of participants
Interval 91.3 to 97.5
|
94.5 percentage of participants
Interval 90.8 to 97.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the Toddler Dose
Additional Serotypes - Serotype 5 (n=226,238)
|
99.6 percentage of participants
Interval 97.6 to 100.0
|
100.0 percentage of participants
Interval 98.5 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the Toddler Dose
Additional Serotypes - Serotype 6A (n=226,237)
|
99.6 percentage of participants
Interval 97.6 to 100.0
|
100.0 percentage of participants
Interval 98.5 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the Toddler Dose
Additional Serotypes - Serotype 7F (n=226,238)
|
100.0 percentage of participants
Interval 98.4 to 100.0
|
100.0 percentage of participants
Interval 98.5 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: one month after the toddler dose (at 13 months of age)Population: Evaluable immunogenicity population had valid and determinate assay results, and had no other major protocol violations, (n) = number of participants with a determinate IgG antibody concentration for the specified serotype.
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.
Outcome measures
| Measure |
13vPnC + Polysorbate 80 After the Infant Series
n=227 Participants
Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
|
13vPnC - Polysorbate 80 After the Infant Series
n=238 Participants
Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
|
13vPnC + P80 Dose 2 Infant Series
Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 months age (infant series, Dose 2).
|
13vPnC - P80 Dose 2 Infant Series
Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 months age (infant series, Dose 2).
|
13vPnC + P80 Dose 3 Infant Series
Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant series, Dose 3).
|
13vPnC - P80 Dose 3 Infant Series
Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant series, Dose 3).
|
13vPnC + P80 Toddler Dose
Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant series), and Priorix at 12 months of age (toddler dose).
|
13vPnC - P80 Toddler Dose
Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant series), and Priorix at 12 months of age (toddler dose).
|
|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose
Common Serotypes - Serotype 18C (n=226,238)
|
3.40 μg/mL
Interval 3.06 to 3.78
|
3.10 μg/mL
Interval 2.79 to 3.45
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose
Common Serotypes - Serotype 4 (n=226,238)
|
5.25 μg/mL
Interval 4.65 to 5.92
|
5.38 μg/mL
Interval 4.78 to 6.07
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose
Common Serotypes - Serotype 6B (n=221,228)
|
9.89 μg/mL
Interval 8.7 to 11.23
|
10.65 μg/mL
Interval 9.4 to 12.06
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose
Common Serotypes - Serotype 9V (n=226,238)
|
3.01 μg/mL
Interval 2.73 to 3.31
|
3.10 μg/mL
Interval 2.8 to 3.42
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose
Common Serotypes - Serotype 14 (n=224,238)
|
11.72 μg/mL
Interval 10.26 to 13.4
|
11.95 μg/mL
Interval 10.42 to 13.71
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose
Common Serotypes - Serotype 19F (n=223,236)
|
9.63 μg/mL
Interval 8.45 to 10.97
|
10.27 μg/mL
Interval 8.99 to 11.73
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose
Common Serotypes - Serotype 23F (n=223,236)
|
3.88 μg/mL
Interval 3.44 to 4.38
|
4.15 μg/mL
Interval 3.73 to 4.62
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose
Additional Serotypes - Serotype 1 (n=226,238)
|
6.03 μg/mL
Interval 5.36 to 6.78
|
6.11 μg/mL
Interval 5.43 to 6.87
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose
Additional Serotypes - Serotype 3 (n=213,226)
|
1.09 μg/mL
Interval 0.99 to 1.2
|
1.16 μg/mL
Interval 1.05 to 1.29
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose
Additional Serotypes - Serotype 7F (n=226,238)
|
5.36 μg/mL
Interval 4.89 to 5.88
|
4.95 μg/mL
Interval 4.5 to 5.44
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose
Additional Serotypes - Serotype 5 (n=225,234)
|
3.80 μg/mL
Interval 3.41 to 4.23
|
3.98 μg/mL
Interval 3.59 to 4.41
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose
Additional Serotypes - Serotype 6A (n=224,236)
|
7.48 μg/mL
Interval 6.66 to 8.4
|
8.19 μg/mL
Interval 7.38 to 9.09
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose
Additional Serotypes - Serotype 19A (n=224,236)
|
13.20 μg/mL
Interval 11.88 to 14.67
|
13.02 μg/mL
Interval 11.88 to 14.27
|
—
|
—
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Within 4-days after each dosePopulation: The safety population included all participants who received at least 1 dose of vaccine, (n) = number of participants reporting yes for at least 1 day or no for all days.
Local reactions were collected using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (Sig) (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness 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 + Polysorbate 80 After the Infant Series
n=250 Participants
Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
|
13vPnC - Polysorbate 80 After the Infant Series
n=250 Participants
Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
|
13vPnC + P80 Dose 2 Infant Series
n=246 Participants
Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 months age (infant series, Dose 2).
|
13vPnC - P80 Dose 2 Infant Series
n=249 Participants
Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 months age (infant series, Dose 2).
|
13vPnC + P80 Dose 3 Infant Series
n=246 Participants
Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant series, Dose 3).
|
13vPnC - P80 Dose 3 Infant Series
n=247 Participants
Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant series, Dose 3).
|
13vPnC + P80 Toddler Dose
n=240 Participants
Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant series), and Priorix at 12 months of age (toddler dose).
|
13vPnC - P80 Toddler Dose
n=244 Participants
Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant series), and Priorix at 12 months of age (toddler dose).
|
|---|---|---|---|---|---|---|---|---|
|
Percent of Participants Reporting Pre-Specified Local Reactions
Tenderness-Any (n=238,237,228,229,210,216,178,188)
|
27.7 Percentage of Participants
|
32.9 Percentage of Participants
|
26.8 Percentage of Participants
|
32.8 Percentage of Participants
|
24.8 Percentage of Participants
|
23.1 Percentage of Participants
|
42.1 Percentage of Participants
|
43.1 Percentage of Participants
|
|
Percent of Participants Reporting Pre-Specified Local Reactions
Tenderness-Sig (n=235,233,220,221,203,211,160,165)
|
2.1 Percentage of Participants
|
4.3 Percentage of Participants
|
0.9 Percentage of Participants
|
0.5 Percentage of Participants
|
1.5 Percentage of Participants
|
1.9 Percentage of Participants
|
2.5 Percentage of Participants
|
1.2 Percentage of Participants
|
|
Percent of Participants Reporting Pre-Specified Local Reactions
Swelling-Any (n=236,239,228,228,210,225,174,181)
|
22.9 Percentage of Participants
|
30.5 Percentage of Participants
|
25.0 Percentage of Participants
|
36.4 Percentage of Participants
|
36.7 Percentage of Participants
|
38.2 Percentage of Participants
|
29.9 Percentage of Participants
|
34.8 Percentage of Participants
|
|
Percent of Participants Reporting Pre-Specified Local Reactions
Swelling-Mild (n=236,236,227,226,209,221,169,178)
|
18.2 Percentage of Participants
|
24.2 Percentage of Participants
|
20.3 Percentage of Participants
|
31.9 Percentage of Participants
|
32.5 Percentage of Participants
|
33.5 Percentage of Participants
|
26.6 Percentage of Participants
|
29.8 Percentage of Participants
|
|
Percent of Participants Reporting Pre-Specified Local Reactions
Swelling-Mod (n=236,236,224,224,208,217,164,171)
|
11.9 Percentage of Participants
|
14.4 Percentage of Participants
|
11.2 Percentage of Participants
|
14.3 Percentage of Participants
|
13.9 Percentage of Participants
|
17.5 Percentage of Participants
|
12.2 Percentage of Participants
|
19.9 Percentage of Participants
|
|
Percent of Participants Reporting Pre-Specified Local Reactions
Swelling-Severe(n=235,233,220,221,203,211,159,164)
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
|
Percent of Participants Reporting Pre-Specified Local Reactions
Redness-Any (n=238,238,232,231,216,226,178,200)
|
29.8 Percentage of Participants
|
39.5 Percentage of Participants
|
38.8 Percentage of Participants
|
48.5 Percentage of Participants
|
46.8 Percentage of Participants
|
50.0 Percentage of Participants
|
42.1 Percentage of Participants
|
52.0 Percentage of Participants
|
|
Percent of Participants Reporting Pre-Specified Local Reactions
Redness-Mild (n=238,235,232,230,215,226,176,194)
|
28.2 Percentage of Participants
|
35.7 Percentage of Participants
|
38.4 Percentage of Participants
|
47.0 Percentage of Participants
|
46.5 Percentage of Participants
|
46.9 Percentage of Participants
|
35.8 Percentage of Participants
|
46.4 Percentage of Participants
|
|
Percent of Participants Reporting Pre-Specified Local Reactions
Redness-Mod (n=235,232,220,222,206,211,164,173)
|
2.1 Percentage of Participants
|
4.3 Percentage of Participants
|
1.4 Percentage of Participants
|
3.2 Percentage of Participants
|
3.9 Percentage of Participants
|
9.0 Percentage of Participants
|
12.8 Percentage of Participants
|
19.7 Percentage of Participants
|
|
Percent of Participants Reporting Pre-Specified Local Reactions
Redness-Severe (n=235,231,220,221,203,211,159,164)
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.6 Percentage of Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Within 4-days after each dosePopulation: The safety population included all subjects who received at least 1 dose of vaccine, (n) = number of participants reporting yes for at least 1 day or no for all days.
Systemic events (fever \[Fv\] ≥ 37.5 degrees Celsius \[C\], fever ≥ 38 C but ≤ 39 C, fever \>39 C but ≤ 40 C, fever \> 40 C, decreased (decr)appetite, irritability, increased (incr)sleep, decreased sleep, hives, use of medication (meds) to treat symptoms (sx), and use of medication to prevent symptoms) were reported using an electronic diary. Participants may be represented in more than 1 category.
Outcome measures
| Measure |
13vPnC + Polysorbate 80 After the Infant Series
n=250 Participants
Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
|
13vPnC - Polysorbate 80 After the Infant Series
n=250 Participants
Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
|
13vPnC + P80 Dose 2 Infant Series
n=246 Participants
Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 months age (infant series, Dose 2).
|
13vPnC - P80 Dose 2 Infant Series
n=249 Participants
Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 months age (infant series, Dose 2).
|
13vPnC + P80 Dose 3 Infant Series
n=246 Participants
Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant series, Dose 3).
|
13vPnC - P80 Dose 3 Infant Series
n=247 Participants
Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant series, Dose 3).
|
13vPnC + P80 Toddler Dose
n=240 Participants
Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant series), and Priorix at 12 months of age (toddler dose).
|
13vPnC - P80 Toddler Dose
n=244 Participants
Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant series), and Priorix at 12 months of age (toddler dose).
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Reporting Pre-Specified Systemic Events
Fv ≥38°C, ≤39°C(n=236,235,224,229,208,218,170,172)
|
14.0 Percentage of Participants
|
16.2 Percentage of Participants
|
18.3 Percentage of Participants
|
17.0 Percentage of Participants
|
19.7 Percentage of Participants
|
20.6 Percentage of Participants
|
22.9 Percentage of Participants
|
18.0 Percentage of Participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events
Fv >39°C, ≤40°C(n=235,233,221,221,203,211,162,164)
|
0.4 Percentage of Participants
|
0.4 Percentage of Participants
|
0.9 Percentage of Participants
|
0.5 Percentage of Participants
|
1.0 Percentage of Participants
|
0.9 Percentage of Participants
|
2.5 Percentage of Participants
|
1.8 Percentage of Participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events
Fv >40°C (n=235,233,221,221,203,211,160,164)
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events
Decr appetite (n=237,237,221,224,210,222,172,183)
|
21.5 Percentage of Participants
|
22.4 Percentage of Participants
|
16.3 Percentage of Participants
|
24.1 Percentage of Participants
|
21.4 Percentage of Participants
|
20.7 Percentage of Participants
|
26.2 Percentage of Participants
|
29.0 Percentage of Participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events
Irritability (n=240,239,232,232,215,226,184,198)
|
55.0 Percentage of Participants
|
55.2 Percentage of Participants
|
51.7 Percentage of Participants
|
53.9 Percentage of Participants
|
45.6 Percentage of Participants
|
50.0 Percentage of Participants
|
49.5 Percentage of Participants
|
56.1 Percentage of Participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events
Incr sleep (n=242,242,231,229,209,221,174,182)
|
46.3 Percentage of Participants
|
52.5 Percentage of Participants
|
35.9 Percentage of Participants
|
39.3 Percentage of Participants
|
25.8 Percentage of Participants
|
27.6 Percentage of Participants
|
19.0 Percentage of Participants
|
30.8 Percentage of Participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events
Decr sleep (n=238,236,227,227,209,217,170,180)
|
35.7 Percentage of Participants
|
29.7 Percentage of Participants
|
24.7 Percentage of Participants
|
26.4 Percentage of Participants
|
25.4 Percentage of Participants
|
24.4 Percentage of Participants
|
19.4 Percentage of Participants
|
25.6 Percentage of Participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events
Meds-treat sx (n=236,235,222,226,205,218,172,168)
|
14.0 Percentage of Participants
|
16.6 Percentage of Participants
|
15.3 Percentage of Participants
|
16.8 Percentage of Participants
|
15.1 Percentage of Participants
|
14.7 Percentage of Participants
|
21.5 Percentage of Participants
|
15.5 Percentage of Participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events
Meds-prevent sx(n=235,234,220,223,205,217,171,171)
|
14.5 Percentage of Participants
|
15.8 Percentage of Participants
|
16.4 Percentage of Participants
|
15.2 Percentage of Participants
|
15.1 Percentage of Participants
|
10.6 Percentage of Participants
|
18.7 Percentage of Participants
|
15.2 Percentage of Participants
|
Adverse Events
13vPnC + P80 Infant Series
Serious events: 15 serious events
Other events: 132 other events
Deaths: 0 deaths
13vPnC - P 80 Infant Series
Serious events: 21 serious events
Other events: 132 other events
Deaths: 0 deaths
13vPnC + P80 Post-Infant Series
Serious events: 24 serious events
Other events: 15 other events
Deaths: 0 deaths
13vPnC - P80 Post-Infant Series
Serious events: 16 serious events
Other events: 9 other events
Deaths: 0 deaths
13vPnC + P80 Toddler Dose
Serious events: 3 serious events
Other events: 91 other events
Deaths: 0 deaths
13vPnC - P80 Toddler Dose
Serious events: 2 serious events
Other events: 111 other events
Deaths: 0 deaths
13vPnC + P80 6-Month Follow-up
Serious events: 13 serious events
Other events: 0 other events
Deaths: 0 deaths
13vPnC - P80 6-Month Follow-up
Serious events: 14 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
13vPnC + P80 Infant Series
n=249 participants at risk
Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
|
13vPnC - P 80 Infant Series
n=250 participants at risk
Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
|
13vPnC + P80 Post-Infant Series
n=249 participants at risk
Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
|
13vPnC - P80 Post-Infant Series
n=250 participants at risk
Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
|
13vPnC + P80 Toddler Dose
n=239 participants at risk
Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
|
13vPnC - P80 Toddler Dose
n=244 participants at risk
Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
|
13vPnC + P80 6-Month Follow-up
n=249 participants at risk
Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
|
13vPnC - P80 6-Month Follow-up
n=250 participants at risk
Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
|
|---|---|---|---|---|---|---|---|---|
|
Immune system disorders
Alloimmunisation
|
0.00%
0/249
|
0.00%
0/250
|
0.40%
1/249
|
0.00%
0/250
|
0.00%
0/239
|
0.00%
0/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/249
|
0.40%
1/250
|
0.00%
0/249
|
0.00%
0/250
|
0.00%
0/239
|
0.00%
0/244
|
0.40%
1/249
|
0.00%
0/250
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/249
|
0.00%
0/250
|
0.00%
0/249
|
0.00%
0/250
|
0.00%
0/239
|
0.00%
0/244
|
0.00%
0/249
|
0.40%
1/250
|
|
Psychiatric disorders
Breath holding
|
0.00%
0/249
|
0.00%
0/250
|
0.40%
1/249
|
0.00%
0/250
|
0.00%
0/239
|
0.00%
0/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Infections and infestations
Bronchitis
|
1.6%
4/249
|
3.6%
9/250
|
2.0%
5/249
|
0.40%
1/250
|
0.00%
0/239
|
0.41%
1/244
|
0.40%
1/249
|
0.80%
2/250
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/249
|
1.2%
3/250
|
0.00%
0/249
|
0.00%
0/250
|
0.00%
0/239
|
0.00%
0/244
|
0.40%
1/249
|
0.00%
0/250
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/249
|
0.00%
0/250
|
0.00%
0/249
|
0.40%
1/250
|
0.00%
0/239
|
0.00%
0/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/249
|
0.00%
0/250
|
0.00%
0/249
|
0.00%
0/250
|
0.00%
0/239
|
0.00%
0/244
|
0.00%
0/249
|
0.40%
1/250
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/249
|
0.00%
0/250
|
0.40%
1/249
|
0.00%
0/250
|
0.00%
0/239
|
0.00%
0/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Gastrointestinal disorders
Diarrhoea
|
0.80%
2/249
|
0.80%
2/250
|
1.6%
4/249
|
1.2%
3/250
|
0.42%
1/239
|
0.00%
0/244
|
1.2%
3/249
|
1.6%
4/250
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/249
|
0.00%
0/250
|
0.40%
1/249
|
0.00%
0/250
|
0.00%
0/239
|
0.00%
0/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Nervous system disorders
Febrile convulsion
|
0.00%
0/249
|
0.00%
0/250
|
0.40%
1/249
|
0.00%
0/250
|
0.00%
0/239
|
0.00%
0/244
|
0.00%
0/249
|
0.00%
0/250
|
|
General disorders
Fibrosis
|
0.00%
0/249
|
0.00%
0/250
|
0.00%
0/249
|
0.00%
0/250
|
0.42%
1/239
|
0.00%
0/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/249
|
0.00%
0/250
|
0.00%
0/249
|
0.00%
0/250
|
0.00%
0/239
|
0.41%
1/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Infections and infestations
Gastroenteritis
|
0.80%
2/249
|
0.40%
1/250
|
1.6%
4/249
|
1.2%
3/250
|
0.00%
0/239
|
0.00%
0/244
|
0.00%
0/249
|
0.40%
1/250
|
|
Infections and infestations
Gastroenteritis rotavirus
|
0.00%
0/249
|
0.00%
0/250
|
0.00%
0/249
|
0.00%
0/250
|
0.00%
0/239
|
0.00%
0/244
|
0.00%
0/249
|
0.40%
1/250
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.40%
1/249
|
0.00%
0/250
|
0.00%
0/249
|
0.00%
0/250
|
0.00%
0/239
|
0.00%
0/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/249
|
0.00%
0/250
|
0.80%
2/249
|
0.00%
0/250
|
0.00%
0/239
|
0.00%
0/244
|
0.40%
1/249
|
0.00%
0/250
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/249
|
0.00%
0/250
|
0.40%
1/249
|
0.00%
0/250
|
0.00%
0/239
|
0.00%
0/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/249
|
0.40%
1/250
|
0.00%
0/249
|
0.00%
0/250
|
0.00%
0/239
|
0.00%
0/244
|
0.00%
0/249
|
0.40%
1/250
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/249
|
0.40%
1/250
|
0.00%
0/249
|
0.00%
0/250
|
0.00%
0/239
|
0.00%
0/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Renal and urinary disorders
Hypercalciuria
|
0.00%
0/249
|
0.00%
0/250
|
0.00%
0/249
|
0.40%
1/250
|
0.00%
0/239
|
0.00%
0/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Immune system disorders
Hypersensitivity
|
0.40%
1/249
|
0.00%
0/250
|
0.00%
0/249
|
0.00%
0/250
|
0.00%
0/239
|
0.00%
0/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Infections and infestations
Infectious mononucleosis
|
0.00%
0/249
|
0.00%
0/250
|
0.40%
1/249
|
0.00%
0/250
|
0.00%
0/239
|
0.00%
0/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Gastrointestinal disorders
Inguinal hernia, obstructive
|
0.00%
0/249
|
0.00%
0/250
|
0.00%
0/249
|
0.40%
1/250
|
0.00%
0/239
|
0.00%
0/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Infections and infestations
Laryngitis
|
0.40%
1/249
|
0.00%
0/250
|
0.40%
1/249
|
0.80%
2/250
|
0.42%
1/239
|
0.00%
0/244
|
1.2%
3/249
|
0.00%
0/250
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/249
|
0.00%
0/250
|
0.40%
1/249
|
0.00%
0/250
|
0.00%
0/239
|
0.00%
0/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Injury, poisoning and procedural complications
Limbic traumatic amputation
|
0.00%
0/249
|
0.00%
0/250
|
0.00%
0/249
|
0.40%
1/250
|
0.00%
0/239
|
0.00%
0/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Infections and infestations
Meningitis meningococcal
|
0.00%
0/249
|
0.40%
1/250
|
0.00%
0/249
|
0.00%
0/250
|
0.00%
0/239
|
0.00%
0/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Infections and infestations
Meningococcal sepsis
|
0.00%
0/249
|
0.40%
1/250
|
0.00%
0/249
|
0.00%
0/250
|
0.00%
0/239
|
0.00%
0/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/249
|
0.00%
0/250
|
0.40%
1/249
|
0.40%
1/250
|
0.00%
0/239
|
0.00%
0/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Infections and infestations
Otitis media
|
0.00%
0/249
|
0.00%
0/250
|
0.40%
1/249
|
0.00%
0/250
|
0.00%
0/239
|
0.00%
0/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/249
|
0.00%
0/250
|
0.80%
2/249
|
0.40%
1/250
|
0.00%
0/239
|
0.00%
0/244
|
0.80%
2/249
|
0.00%
0/250
|
|
Infections and infestations
Pneumonia
|
3.2%
8/249
|
1.2%
3/250
|
2.4%
6/249
|
0.40%
1/250
|
0.00%
0/239
|
0.00%
0/244
|
1.2%
3/249
|
1.2%
3/250
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.40%
1/249
|
0.40%
1/250
|
0.00%
0/249
|
0.00%
0/250
|
0.00%
0/239
|
0.00%
0/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Infections and infestations
Pneumonia primary atypical
|
0.00%
0/249
|
0.40%
1/250
|
0.00%
0/249
|
0.40%
1/250
|
0.00%
0/239
|
0.00%
0/244
|
0.00%
0/249
|
0.00%
0/250
|
|
General disorders
Pyrexia
|
0.00%
0/249
|
0.00%
0/250
|
0.00%
0/249
|
0.40%
1/250
|
0.00%
0/239
|
0.00%
0/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/249
|
0.00%
0/250
|
0.00%
0/249
|
0.00%
0/250
|
0.00%
0/239
|
0.00%
0/244
|
0.40%
1/249
|
0.00%
0/250
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
0.00%
0/249
|
0.00%
0/250
|
0.00%
0/249
|
0.00%
0/250
|
0.00%
0/239
|
0.00%
0/244
|
0.40%
1/249
|
0.00%
0/250
|
|
Renal and urinary disorders
Renal tubular disorder
|
0.00%
0/249
|
0.00%
0/250
|
0.00%
0/249
|
0.40%
1/250
|
0.00%
0/239
|
0.00%
0/244
|
0.00%
0/249
|
0.40%
1/250
|
|
Infections and infestations
Respiratory tract infection
|
0.40%
1/249
|
0.40%
1/250
|
0.00%
0/249
|
0.40%
1/250
|
0.00%
0/239
|
0.00%
0/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Infections and infestations
Rhinitis
|
0.00%
0/249
|
0.80%
2/250
|
0.00%
0/249
|
0.00%
0/250
|
0.00%
0/239
|
0.00%
0/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Infections and infestations
Sepsis
|
0.00%
0/249
|
0.00%
0/250
|
0.00%
0/249
|
0.00%
0/250
|
0.00%
0/239
|
0.00%
0/244
|
0.40%
1/249
|
0.00%
0/250
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/249
|
0.40%
1/250
|
0.00%
0/249
|
0.00%
0/250
|
0.00%
0/239
|
0.00%
0/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.00%
0/249
|
0.00%
0/250
|
0.40%
1/249
|
0.00%
0/250
|
0.00%
0/239
|
0.00%
0/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/249
|
0.00%
0/250
|
0.40%
1/249
|
0.00%
0/250
|
0.00%
0/239
|
0.00%
0/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/249
|
0.00%
0/250
|
0.40%
1/249
|
0.00%
0/250
|
0.00%
0/239
|
0.00%
0/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Investigations
Ultrasound kidney abnormal
|
0.00%
0/249
|
0.00%
0/250
|
0.00%
0/249
|
0.40%
1/250
|
0.00%
0/239
|
0.00%
0/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/249
|
0.40%
1/250
|
0.40%
1/249
|
0.80%
2/250
|
0.00%
0/239
|
0.00%
0/244
|
0.00%
0/249
|
0.40%
1/250
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.40%
1/249
|
0.00%
0/250
|
0.00%
0/249
|
0.40%
1/250
|
0.00%
0/239
|
0.00%
0/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Infections and infestations
Viral infection
|
0.00%
0/249
|
0.00%
0/250
|
0.80%
2/249
|
0.00%
0/250
|
0.00%
0/239
|
0.00%
0/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/249
|
0.40%
1/250
|
0.00%
0/249
|
0.00%
0/250
|
0.00%
0/239
|
0.00%
0/244
|
0.00%
0/249
|
0.00%
0/250
|
Other adverse events
| Measure |
13vPnC + P80 Infant Series
n=249 participants at risk
Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
|
13vPnC - P 80 Infant Series
n=250 participants at risk
Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
|
13vPnC + P80 Post-Infant Series
n=249 participants at risk
Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
|
13vPnC - P80 Post-Infant Series
n=250 participants at risk
Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
|
13vPnC + P80 Toddler Dose
n=239 participants at risk
Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
|
13vPnC - P80 Toddler Dose
n=244 participants at risk
Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
|
13vPnC + P80 6-Month Follow-up
n=249 participants at risk
Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
|
13vPnC - P80 6-Month Follow-up
n=250 participants at risk
Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
|
|---|---|---|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Induration (mild)
|
30.9%
51/165
|
32.7%
56/171
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
Skin and subcutaneous tissue disorders
Induration (moderate)
|
14.0%
23/164
|
17.8%
30/169
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
Blood and lymphatic system disorders
Anaemia
|
0.80%
2/249
|
0.80%
2/250
|
0.00%
0/249
|
0.00%
0/250
|
0.00%
0/239
|
0.00%
0/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/249
|
0.40%
1/250
|
0.00%
0/249
|
0.00%
0/250
|
0.00%
0/239
|
0.00%
0/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Cardiac disorders
Aortic valve incompetence
|
0.00%
0/249
|
0.00%
0/250
|
0.00%
0/249
|
0.40%
1/250
|
0.00%
0/239
|
0.00%
0/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Cardiac disorders
Tricuspid valve incompetence
|
0.00%
0/249
|
0.00%
0/250
|
0.00%
0/249
|
0.40%
1/250
|
0.00%
0/239
|
0.00%
0/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Congenital, familial and genetic disorders
Craniotabes
|
0.00%
0/249
|
0.40%
1/250
|
0.00%
0/249
|
0.00%
0/250
|
0.00%
0/239
|
0.00%
0/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Congenital, familial and genetic disorders
Dacryostenosis congenital
|
0.00%
0/249
|
0.40%
1/250
|
0.00%
0/249
|
0.00%
0/250
|
0.00%
0/239
|
0.00%
0/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Congenital, familial and genetic disorders
Brachycephaly
|
0.00%
0/249
|
0.00%
0/250
|
0.00%
0/249
|
0.40%
1/250
|
0.00%
0/239
|
0.00%
0/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Congenital, familial and genetic disorders
Cryptorchism
|
0.00%
0/249
|
0.00%
0/250
|
0.40%
1/249
|
0.00%
0/250
|
0.00%
0/239
|
0.41%
1/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Congenital, familial and genetic disorders
Ventricular septal defect
|
0.00%
0/249
|
0.00%
0/250
|
0.00%
0/249
|
0.40%
1/250
|
0.00%
0/239
|
0.00%
0/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Eye disorders
Conjunctivitis
|
2.0%
5/249
|
0.80%
2/250
|
0.40%
1/249
|
0.00%
0/250
|
0.00%
0/239
|
1.2%
3/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Gastrointestinal disorders
Diarrhoea
|
2.0%
5/249
|
4.4%
11/250
|
0.00%
0/249
|
0.00%
0/250
|
1.7%
4/239
|
2.0%
5/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Gastrointestinal disorders
Vomiting
|
0.80%
2/249
|
1.2%
3/250
|
0.00%
0/249
|
0.00%
0/250
|
0.42%
1/239
|
0.00%
0/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Gastrointestinal disorders
Abdominal pain
|
0.40%
1/249
|
0.80%
2/250
|
0.00%
0/249
|
0.00%
0/250
|
0.00%
0/239
|
0.00%
0/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Gastrointestinal disorders
Haematochezia
|
0.40%
1/249
|
0.40%
1/250
|
0.00%
0/249
|
0.00%
0/250
|
0.00%
0/239
|
0.00%
0/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Gastrointestinal disorders
Abdominal distension
|
0.40%
1/249
|
0.00%
0/250
|
0.00%
0/249
|
0.00%
0/250
|
0.00%
0/239
|
0.00%
0/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.00%
0/249
|
0.40%
1/250
|
0.00%
0/249
|
0.00%
0/250
|
0.00%
0/239
|
0.00%
0/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/249
|
0.40%
1/250
|
0.00%
0/249
|
0.00%
0/250
|
0.00%
0/239
|
0.00%
0/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Gastrointestinal disorders
Dyspepsia
|
0.40%
1/249
|
0.00%
0/250
|
0.00%
0/249
|
0.00%
0/250
|
0.42%
1/239
|
0.00%
0/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Gastrointestinal disorders
Infantile colic
|
0.40%
1/249
|
0.00%
0/250
|
0.00%
0/249
|
0.00%
0/250
|
0.00%
0/239
|
0.00%
0/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.40%
1/249
|
0.00%
0/250
|
0.00%
0/249
|
0.00%
0/250
|
0.00%
0/239
|
0.00%
0/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/249
|
0.00%
0/250
|
0.80%
2/249
|
0.00%
0/250
|
0.00%
0/239
|
0.00%
0/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/249
|
0.00%
0/250
|
0.00%
0/249
|
0.00%
0/250
|
0.42%
1/239
|
0.00%
0/244
|
0.00%
0/249
|
0.00%
0/250
|
|
General disorders
Pyrexia
|
2.0%
5/249
|
1.6%
4/250
|
0.00%
0/249
|
0.00%
0/250
|
0.42%
1/239
|
0.41%
1/244
|
0.00%
0/249
|
0.00%
0/250
|
|
General disorders
Irritability
|
45.6%
98/215
|
50.0%
113/226
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
General disorders
Injection site induration
|
0.40%
1/249
|
0.00%
0/250
|
0.00%
0/249
|
0.00%
0/250
|
0.00%
0/239
|
0.00%
0/244
|
0.00%
0/249
|
0.00%
0/250
|
|
General disorders
Injection site nodule
|
0.40%
1/249
|
0.00%
0/250
|
0.00%
0/249
|
0.00%
0/250
|
0.00%
0/239
|
0.00%
0/244
|
0.00%
0/249
|
0.00%
0/250
|
|
General disorders
Injection site swelling
|
0.00%
0/249
|
0.40%
1/250
|
0.00%
0/249
|
0.00%
0/250
|
0.00%
0/239
|
0.00%
0/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Immune system disorders
Food allergy
|
0.00%
0/249
|
1.2%
3/250
|
0.00%
0/249
|
0.00%
0/250
|
0.00%
0/239
|
0.41%
1/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Infections and infestations
Bronchitis
|
9.2%
23/249
|
7.6%
19/250
|
0.00%
0/249
|
0.00%
0/250
|
1.3%
3/239
|
2.5%
6/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Infections and infestations
Rhinitis
|
7.6%
19/249
|
8.4%
21/250
|
1.2%
3/249
|
0.40%
1/250
|
3.3%
8/239
|
4.1%
10/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Infections and infestations
Pharyngitis
|
6.8%
17/249
|
6.0%
15/250
|
0.00%
0/249
|
0.00%
0/250
|
4.2%
10/239
|
7.8%
19/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Infections and infestations
Upper respiratory tract infection
|
6.8%
17/249
|
5.2%
13/250
|
0.00%
0/249
|
0.00%
0/250
|
3.8%
9/239
|
7.0%
17/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Infections and infestations
Nasopharyngitis
|
5.2%
13/249
|
5.2%
13/250
|
0.40%
1/249
|
0.00%
0/250
|
1.7%
4/239
|
4.1%
10/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Infections and infestations
Respiratory tract infection
|
3.2%
8/249
|
2.4%
6/250
|
0.00%
0/249
|
0.00%
0/250
|
0.84%
2/239
|
0.41%
1/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Infections and infestations
Urinary tract infection
|
2.8%
7/249
|
0.40%
1/250
|
0.00%
0/249
|
0.00%
0/250
|
0.42%
1/239
|
0.00%
0/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Infections and infestations
Bronchopneumonia
|
0.80%
2/249
|
1.2%
3/250
|
0.00%
0/249
|
0.00%
0/250
|
0.00%
0/239
|
0.00%
0/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Infections and infestations
Pneumonia
|
1.2%
3/249
|
0.80%
2/250
|
0.00%
0/249
|
0.00%
0/250
|
0.84%
2/239
|
0.00%
0/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Infections and infestations
Viral infection
|
0.80%
2/249
|
1.2%
3/250
|
0.00%
0/249
|
0.00%
0/250
|
0.42%
1/239
|
0.41%
1/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Infections and infestations
Ear infection
|
0.80%
2/249
|
0.80%
2/250
|
0.00%
0/249
|
0.00%
0/250
|
0.00%
0/239
|
0.00%
0/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Infections and infestations
Gastroenteritis
|
1.2%
3/249
|
0.40%
1/250
|
0.00%
0/249
|
0.00%
0/250
|
1.3%
3/239
|
0.41%
1/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Infections and infestations
Laryngitis
|
0.80%
2/249
|
0.40%
1/250
|
0.00%
0/249
|
0.00%
0/250
|
0.42%
1/239
|
1.6%
4/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Infections and infestations
Otitis media
|
0.80%
2/249
|
0.40%
1/250
|
0.00%
0/249
|
0.00%
0/250
|
0.42%
1/239
|
0.82%
2/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Infections and infestations
Exanthema subitum
|
0.40%
1/249
|
0.40%
1/250
|
0.00%
0/249
|
0.00%
0/250
|
0.00%
0/239
|
2.0%
5/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.40%
1/249
|
0.40%
1/250
|
0.00%
0/249
|
0.00%
0/250
|
0.00%
0/239
|
0.00%
0/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Infections and infestations
Candidiasis
|
0.40%
1/249
|
0.00%
0/250
|
0.00%
0/249
|
0.00%
0/250
|
0.00%
0/239
|
0.00%
0/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Infections and infestations
Conjunctivitis infective
|
0.00%
0/249
|
0.40%
1/250
|
0.00%
0/249
|
0.00%
0/250
|
0.00%
0/239
|
0.00%
0/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Infections and infestations
Gastroenteritis staphylococcal
|
0.40%
1/249
|
0.00%
0/250
|
0.00%
0/249
|
0.00%
0/250
|
0.00%
0/239
|
0.00%
0/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Infections and infestations
Oral candidiasis
|
0.40%
1/249
|
0.00%
0/250
|
0.00%
0/249
|
0.00%
0/250
|
0.00%
0/239
|
0.00%
0/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Infections and infestations
Perianal abscess
|
0.40%
1/249
|
0.00%
0/250
|
0.00%
0/249
|
0.00%
0/250
|
0.00%
0/239
|
0.00%
0/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Infections and infestations
Pneumonia primary atypical
|
0.00%
0/249
|
0.40%
1/250
|
0.00%
0/249
|
0.00%
0/250
|
0.00%
0/239
|
0.00%
0/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Infections and infestations
Tinea cruris
|
0.40%
1/249
|
0.00%
0/250
|
0.00%
0/249
|
0.00%
0/250
|
0.00%
0/239
|
0.00%
0/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Infections and infestations
Tonsillitis
|
0.40%
1/249
|
0.00%
0/250
|
0.00%
0/249
|
0.00%
0/250
|
0.42%
1/239
|
0.41%
1/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Infections and infestations
Varicella
|
0.40%
1/249
|
0.00%
0/250
|
0.00%
0/249
|
0.00%
0/250
|
0.42%
1/239
|
0.41%
1/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Infections and infestations
Viral diarrhoea
|
0.00%
0/249
|
0.40%
1/250
|
0.00%
0/249
|
0.00%
0/250
|
0.00%
0/239
|
0.00%
0/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Infections and infestations
Viral rash
|
0.40%
1/249
|
0.00%
0/250
|
0.00%
0/249
|
0.00%
0/250
|
0.00%
0/239
|
0.00%
0/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Infections and infestations
Hordeolum
|
0.00%
0/249
|
0.00%
0/250
|
0.00%
0/249
|
0.40%
1/250
|
0.00%
0/239
|
0.00%
0/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Infections and infestations
Acute tonsillitis
|
0.00%
0/249
|
0.00%
0/250
|
0.00%
0/249
|
0.00%
0/250
|
0.00%
0/239
|
0.82%
2/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Infections and infestations
Influenza
|
0.00%
0/249
|
0.00%
0/250
|
0.00%
0/249
|
0.00%
0/250
|
0.42%
1/239
|
0.00%
0/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Investigations
Cardiac murmur functional
|
0.40%
1/249
|
0.80%
2/250
|
0.00%
0/249
|
0.00%
0/250
|
0.00%
0/239
|
0.00%
0/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Investigations
Cardiac murmur
|
0.00%
0/249
|
0.00%
0/250
|
0.00%
0/249
|
0.40%
1/250
|
0.00%
0/239
|
0.00%
0/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Metabolism and nutrition disorders
Weight gain poor
|
0.00%
0/249
|
0.00%
0/250
|
0.00%
0/249
|
0.40%
1/250
|
0.00%
0/239
|
0.00%
0/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Nervous system disorders
Hypertonia
|
0.40%
1/249
|
1.2%
3/250
|
0.00%
0/249
|
0.00%
0/250
|
0.00%
0/239
|
0.00%
0/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Nervous system disorders
Hypotonia
|
0.80%
2/249
|
0.00%
0/250
|
0.00%
0/249
|
0.00%
0/250
|
0.00%
0/239
|
0.00%
0/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Psychiatric disorders
Decreased activity
|
0.40%
1/249
|
0.00%
0/250
|
0.00%
0/249
|
0.00%
0/250
|
0.00%
0/239
|
0.00%
0/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/249
|
0.40%
1/250
|
0.00%
0/249
|
0.00%
0/250
|
0.00%
0/239
|
0.00%
0/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.80%
2/249
|
0.00%
0/250
|
0.00%
0/249
|
0.00%
0/250
|
0.00%
0/239
|
0.00%
0/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.40%
1/249
|
0.00%
0/250
|
0.00%
0/249
|
0.00%
0/250
|
0.00%
0/239
|
0.00%
0/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.40%
1/249
|
0.00%
0/250
|
0.00%
0/249
|
0.00%
0/250
|
0.00%
0/239
|
0.00%
0/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.40%
1/249
|
0.00%
0/250
|
0.40%
1/249
|
0.40%
1/250
|
0.00%
0/239
|
0.00%
0/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
5.6%
14/249
|
2.8%
7/250
|
1.2%
3/249
|
0.40%
1/250
|
0.84%
2/239
|
0.41%
1/244
|
0.00%
0/249
|
0.40%
1/250
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
1.2%
3/249
|
3.2%
8/250
|
0.40%
1/249
|
0.80%
2/250
|
0.00%
0/239
|
0.41%
1/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.0%
5/249
|
0.40%
1/250
|
0.40%
1/249
|
0.00%
0/250
|
0.00%
0/239
|
0.00%
0/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.40%
1/249
|
0.40%
1/250
|
0.00%
0/249
|
0.00%
0/250
|
0.00%
0/239
|
0.00%
0/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
0.40%
1/249
|
0.40%
1/250
|
0.40%
1/249
|
0.00%
0/250
|
0.00%
0/239
|
0.00%
0/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Skin and subcutaneous tissue disorders
Heat rash
|
0.80%
2/249
|
0.00%
0/250
|
0.00%
0/249
|
0.00%
0/250
|
0.00%
0/239
|
0.00%
0/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/249
|
0.40%
1/250
|
0.00%
0/249
|
0.00%
0/250
|
0.00%
0/239
|
0.00%
0/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.40%
1/249
|
0.00%
0/250
|
0.00%
0/249
|
0.00%
0/250
|
0.00%
0/239
|
0.00%
0/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.40%
1/249
|
0.00%
0/250
|
0.00%
0/249
|
0.00%
0/250
|
0.00%
0/239
|
0.00%
0/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Skin and subcutaneous tissue disorders
Skin inflammation
|
0.00%
0/249
|
0.40%
1/250
|
0.00%
0/249
|
0.00%
0/250
|
0.00%
0/239
|
0.00%
0/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/249
|
0.40%
1/250
|
0.00%
0/249
|
0.00%
0/250
|
0.00%
0/239
|
0.00%
0/244
|
0.00%
0/249
|
0.00%
0/250
|
|
Skin and subcutaneous tissue disorders
Tenderness (Any)
|
24.9%
45/181
|
32.6%
59/181
|
—
0/0
|
—
0/0
|
42.1%
75/178
|
43.1%
81/188
|
—
0/0
|
—
0/0
|
|
Skin and subcutaneous tissue disorders
Tenderness (any)
|
24.6%
41/167
|
22.4%
38/170
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
Skin and subcutaneous tissue disorders
Tenderness (significant)
|
1.2%
2/163
|
1.2%
2/165
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
Skin and subcutaneous tissue disorders
Induration (Any)
|
35.8%
59/165
|
38.3%
67/175
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
Skin and subcutaneous tissue disorders
Induration (severe)
|
0.00%
0/163
|
0.00%
0/165
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
Skin and subcutaneous tissue disorders
Erythema (Any)
|
46.2%
78/169
|
50.3%
89/177
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
Skin and subcutaneous tissue disorders
Erythema (Mild)
|
46.2%
78/169
|
46.3%
82/177
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
Skin and subcutaneous tissue disorders
Erythema (Moderate)
|
3.0%
5/164
|
9.7%
16/165
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
Skin and subcutaneous tissue disorders
Erythema (Severe)
|
0.00%
0/163
|
0.00%
0/165
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
General disorders
Fever ≥38°C but ≤39°C
|
19.7%
41/208
|
20.6%
45/218
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
General disorders
Fever >39°C but ≤40°C
|
0.99%
2/203
|
0.95%
2/211
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
General disorders
Fever >40°C
|
0.00%
0/203
|
0.00%
0/211
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
General disorders
Decreased appetite
|
21.4%
45/210
|
20.7%
46/222
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
General disorders
Decreased sleep
|
25.4%
53/209
|
24.4%
53/217
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
General disorders
Increased sleep
|
25.8%
54/209
|
27.6%
61/221
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The PIs agreed to allow the sponsor 60 days to review and require changes to presentations or publications but only to protect confidential information and intellectual property, and for the sponsor to file a patent application, as applicable. The PIs also agreed for data to be presented first as a joint, multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER