Trial Outcomes & Findings for Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants (NCT NCT00366678)
NCT ID: NCT00366678
Last Updated: 2012-08-15
Results Overview
Percentage of participants achieving predefined antibody threshold levels ≥0.1 IU/mL for diphtheria, ≥0.1 IU/mL for tetanus, ≥ 0.15 μg/mL for Hib polyribosylribitol phosphate (PRP), antibody titer ≥1:8 for polio and ≥5 EU/mL for pertussis (PT and FHA) with the corresponding 95% CI for each concomitant antigen are presented.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
613 participants
Primary outcome timeframe
One Month After the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age)
Results posted on
2012-08-15
Participant Flow
Participants were recruited in France from October 2006 to July 2007.
Participants were enrolled into the study according to inclusion/exclusion criteria without a screening period.
Participant milestones
| Measure |
13vPnC/13vPnC Vaccine
Participants received one single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with a vaccine containing diphtheria, tetanus, 2-component pertussis (DTaP), inactivated poliovirus (IPV), and hemophilus influenza type b vaccines (Hib) (Pentavac) at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
|
7vPnC/7vPnC Vaccine
Participants received one single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with a vaccine containing diphtheria, tetanus, 2-component pertussis (DTaP), inactivated poliovirus (IPV), and hemophilus influenza type b vaccines (Hib) (Pentavac) at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
|
7vPnC/13vPnC Vaccine
Participants received one single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with a vaccine containing diphtheria, tetanus, 2-component pertussis (DTaP), inactivated poliovirus (IPV), and hemophilus influenza type b vaccines (Hib) (Pentavac) at 2, 3, and 4 months of age (infant series). Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC)coadministered with Pentavac at 12 months of age (toddler dose).
|
|---|---|---|---|
|
Toddler Dose
NOT COMPLETED
|
5
|
1
|
0
|
|
Infant Series
Vaccinated Dose 2
|
295
|
304
|
0
|
|
Infant Series
Vaccinated Dose 3
|
291
|
302
|
0
|
|
Infant Series
COMPLETED
|
290
|
299
|
0
|
|
Infant Series
NOT COMPLETED
|
14
|
10
|
0
|
|
After Infant
STARTED
|
290
|
299
|
0
|
|
After Infant
COMPLETED
|
273
|
289
|
0
|
|
After Infant
NOT COMPLETED
|
17
|
10
|
0
|
|
Toddler Dose
STARTED
|
273
|
152
|
137
|
|
Toddler Dose
COMPLETED
|
268
|
151
|
137
|
|
Infant Series
STARTED
|
304
|
309
|
0
|
|
Infant Series
Vaccinated Dose 1
|
302
|
309
|
0
|
Reasons for withdrawal
| Measure |
13vPnC/13vPnC Vaccine
Participants received one single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with a vaccine containing diphtheria, tetanus, 2-component pertussis (DTaP), inactivated poliovirus (IPV), and hemophilus influenza type b vaccines (Hib) (Pentavac) at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
|
7vPnC/7vPnC Vaccine
Participants received one single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with a vaccine containing diphtheria, tetanus, 2-component pertussis (DTaP), inactivated poliovirus (IPV), and hemophilus influenza type b vaccines (Hib) (Pentavac) at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
|
7vPnC/13vPnC Vaccine
Participants received one single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with a vaccine containing diphtheria, tetanus, 2-component pertussis (DTaP), inactivated poliovirus (IPV), and hemophilus influenza type b vaccines (Hib) (Pentavac) at 2, 3, and 4 months of age (infant series). Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC)coadministered with Pentavac at 12 months of age (toddler dose).
|
|---|---|---|---|
|
Infant Series
Withdrawal by Subject
|
8
|
6
|
0
|
|
Infant Series
Protocol Violation
|
4
|
3
|
0
|
|
Infant Series
Failed to return
|
1
|
1
|
0
|
|
Infant Series
Adverse Event
|
1
|
0
|
0
|
|
After Infant
Withdrawal by Subject
|
8
|
4
|
0
|
|
After Infant
Lost to Follow-up
|
2
|
1
|
0
|
|
After Infant
Failed to return
|
5
|
5
|
0
|
|
After Infant
Adverse Event
|
1
|
0
|
0
|
|
After Infant
Protocol Violation
|
1
|
0
|
0
|
|
Toddler Dose
Protocol Violation
|
2
|
1
|
0
|
|
Toddler Dose
Failed to return
|
1
|
0
|
0
|
|
Toddler Dose
Withdrawal by Subject
|
1
|
0
|
0
|
|
Toddler Dose
protocol deviation
|
1
|
0
|
0
|
Baseline Characteristics
Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants
Baseline characteristics by cohort
| Measure |
13vPnC/13vPnC Vaccine
n=304 Participants
Participants received one single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with a vaccine containing diphtheria, tetanus, 2-component pertussis (DTaP), inactivated poliovirus (IPV), and hemophilus influenza type b vaccines (Hib) (Pentavac) at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
|
7vPnC/7vPnC Vaccine
n=309 Participants
Participants received one single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with a vaccine containing diphtheria, tetanus, 2-component pertussis (DTaP), inactivated poliovirus (IPV), and hemophilus influenza type b vaccines (Hib) (Pentavac) at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
|
Total
n=613 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
|
169 Participants
n=5 Participants
|
164 Participants
n=7 Participants
|
333 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
135 Participants
n=5 Participants
|
145 Participants
n=7 Participants
|
280 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: One Month After the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age)Population: The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.
Percentage of participants achieving predefined antibody threshold levels ≥0.1 IU/mL for diphtheria, ≥0.1 IU/mL for tetanus, ≥ 0.15 μg/mL for Hib polyribosylribitol phosphate (PRP), antibody titer ≥1:8 for polio and ≥5 EU/mL for pertussis (PT and FHA) with the corresponding 95% CI for each concomitant antigen are presented.
Outcome measures
| Measure |
13vPnC After the Infant Series
n=266 Participants
Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
|
7vPnC After the Infant Series
n=263 Participants
Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
|
13vPnC After the Toddler Dose
n=241 Participants
Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
|
7vPnC After the Toddler Dose
n=133 Participants
Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
|
7vPnC/13vPnC Before Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with Pentavac at 2, 3, and 4 months of age (infant series). Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Pentavac at 12 months of age (toddler dose).
|
7vPnC/13vPnC After Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with Pentavac at 2, 3, and 4 months of age (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with Pentavac at 12 months of age (toddler dose), assessment made at 13 months of age.
|
13vPnC/13vPnC Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose).
|
7vPnC/7vPnC Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose).
|
7vPnC/13vPnC Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose).
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria, Tetanus, Hemophilus Influenza Type b (Hib), Poliomyelitis (Type 1, 2, 3), Pertussis Toxin (PT) and Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group
Polio Type 3 (1:8)
|
92.6 percentage of participants
Interval 88.7 to 95.5
|
93.0 percentage of participants
Interval 89.1 to 95.8
|
99.2 percentage of participants
Interval 97.0 to 99.9
|
100.0 percentage of participants
Interval 97.2 to 100.0
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria, Tetanus, Hemophilus Influenza Type b (Hib), Poliomyelitis (Type 1, 2, 3), Pertussis Toxin (PT) and Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group
Diphtheria 0.1 (IU/mL)
|
76.5 percentage of participants
Interval 70.9 to 81.5
|
84.6 percentage of participants
Interval 79.6 to 88.7
|
99.2 percentage of participants
Interval 97.0 to 99.9
|
100 percentage of participants
Interval 97.3 to 100.0
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria, Tetanus, Hemophilus Influenza Type b (Hib), Poliomyelitis (Type 1, 2, 3), Pertussis Toxin (PT) and Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group
Pertussis - PT Infant ≥5 Toddler 5 (EU/mL)
|
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 98.5 to 100.0
|
100.0 percentage of participants
Interval 97.3 to 100.0
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria, Tetanus, Hemophilus Influenza Type b (Hib), Poliomyelitis (Type 1, 2, 3), Pertussis Toxin (PT) and Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group
Pertussis - PT Infant ≥26 Toddler 17 (EU/mL)
|
94.3 percentage of participants
Interval 90.8 to 96.8
|
95.0 percentage of participants
Interval 91.7 to 97.3
|
98.3 percentage of participants
Interval 95.8 to 99.5
|
96.2 percentage of participants
Interval 91.4 to 98.8
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria, Tetanus, Hemophilus Influenza Type b (Hib), Poliomyelitis (Type 1, 2, 3), Pertussis Toxin (PT) and Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group
Pertussis - FHA Infant ≥5 Toddler 5 (EU/mL)
|
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 98.5 to 100.0
|
100.0 percentage of participants
Interval 97.3 to 100.0
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria, Tetanus, Hemophilus Influenza Type b (Hib), Poliomyelitis (Type 1, 2, 3), Pertussis Toxin (PT) and Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group
Pertussis - FHA Infant ≥7.82 Toddler 7.82 (EU/mL)
|
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 98.5 to 100.0
|
100.0 percentage of participants
Interval 97.3 to 100.0
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria, Tetanus, Hemophilus Influenza Type b (Hib), Poliomyelitis (Type 1, 2, 3), Pertussis Toxin (PT) and Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group
Pertussis - FHA Infant ≥36.00 Toddler 75 (EU/mL)
|
93.5 percentage of participants
Interval 89.9 to 96.2
|
95.8 percentage of participants
Interval 92.6 to 97.9
|
92.5 percentage of participants
Interval 88.4 to 95.5
|
95.5 percentage of participants
Interval 90.4 to 98.3
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria, Tetanus, Hemophilus Influenza Type b (Hib), Poliomyelitis (Type 1, 2, 3), Pertussis Toxin (PT) and Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group
Diphtheria 0.01 (IU/mL)
|
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 98.5 to 100.0
|
100.0 percentage of participants
Interval 97.3 to 100.0
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria, Tetanus, Hemophilus Influenza Type b (Hib), Poliomyelitis (Type 1, 2, 3), Pertussis Toxin (PT) and Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group
Tetanus 0.1 (IU/mL)
|
84.9 percentage of participants
Interval 80.0 to 89.1
|
82.2 percentage of participants
Interval 76.9 to 86.7
|
96.2 percentage of participants
Interval 93.0 to 98.3
|
98.5 percentage of participants
Interval 94.7 to 99.8
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria, Tetanus, Hemophilus Influenza Type b (Hib), Poliomyelitis (Type 1, 2, 3), Pertussis Toxin (PT) and Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group
Tetanus 0.01 (IU/mL)
|
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 98.5 to 100.0
|
100.0 percentage of participants
Interval 97.3 to 100.0
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria, Tetanus, Hemophilus Influenza Type b (Hib), Poliomyelitis (Type 1, 2, 3), Pertussis Toxin (PT) and Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group
Polio Type 1 (1:8)
|
88.8 percentage of participants
Interval 84.3 to 92.3
|
91.0 percentage of participants
Interval 86.8 to 94.2
|
97.9 percentage of participants
Interval 95.2 to 99.3
|
98.4 percentage of participants
Interval 94.5 to 99.8
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria, Tetanus, Hemophilus Influenza Type b (Hib), Poliomyelitis (Type 1, 2, 3), Pertussis Toxin (PT) and Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group
Polio Type 2 (1:8)
|
77.7 percentage of participants
Interval 72.1 to 82.6
|
82.0 percentage of participants
Interval 76.8 to 86.5
|
98.7 percentage of participants
Interval 96.4 to 99.7
|
99.2 percentage of participants
Interval 95.8 to 100.0
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria, Tetanus, Hemophilus Influenza Type b (Hib), Poliomyelitis (Type 1, 2, 3), Pertussis Toxin (PT) and Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group
Hib (PRP) 0.15 (μg/mL)
|
95.5 percentage of participants
Interval 92.1 to 97.7
|
94.6 percentage of participants
Interval 91.0 to 97.1
|
100.0 percentage of participants
Interval 98.5 to 100.0
|
100.0 percentage of participants
Interval 97.2 to 100.0
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria, Tetanus, Hemophilus Influenza Type b (Hib), Poliomyelitis (Type 1, 2, 3), Pertussis Toxin (PT) and Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group
Hib (PRP) 1.0 (μg/mL)
|
58.6 percentage of participants
Interval 52.1 to 64.9
|
63.1 percentage of participants
Interval 56.6 to 69.2
|
97.9 percentage of participants
Interval 95.2 to 99.3
|
97.7 percentage of participants
Interval 93.5 to 99.5
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: One month after the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age)Population: The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.
Outcome measures
| Measure |
13vPnC After the Infant Series
n=266 Participants
Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
|
7vPnC After the Infant Series
n=263 Participants
Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
|
13vPnC After the Toddler Dose
n=241 Participants
Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
|
7vPnC After the Toddler Dose
n=133 Participants
Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
|
7vPnC/13vPnC Before Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with Pentavac at 2, 3, and 4 months of age (infant series). Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Pentavac at 12 months of age (toddler dose).
|
7vPnC/13vPnC After Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with Pentavac at 2, 3, and 4 months of age (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with Pentavac at 12 months of age (toddler dose), assessment made at 13 months of age.
|
13vPnC/13vPnC Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose).
|
7vPnC/7vPnC Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose).
|
7vPnC/13vPnC Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose).
|
|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Concentration (GMC) as Measured by Enzyme-linked Immunosorbent Assay (ELISA) for Diphtheria Toxoid and Tetanus Toxoid in 13vPnC Group Relative to 7vPnC Group
Diphtheria
|
0.19 IU/mL
Interval 0.17 to 0.21
|
0.24 IU/mL
Interval 0.22 to 0.27
|
2.09 IU/mL
Interval 1.87 to 2.34
|
2.60 IU/mL
Interval 2.26 to 2.99
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) as Measured by Enzyme-linked Immunosorbent Assay (ELISA) for Diphtheria Toxoid and Tetanus Toxoid in 13vPnC Group Relative to 7vPnC Group
Tetanus
|
0.20 IU/mL
Interval 0.18 to 0.22
|
0.21 IU/mL
Interval 0.19 to 0.23
|
1.08 IU/mL
Interval 0.94 to 1.24
|
1.25 IU/mL
Interval 1.05 to 1.47
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: One month after the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age)Population: Evaluable immunogenicity (per protocol) population adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.
Outcome measures
| Measure |
13vPnC After the Infant Series
n=244 Participants
Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
|
7vPnC After the Infant Series
n=241 Participants
Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
|
13vPnC After the Toddler Dose
n=240 Participants
Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
|
7vPnC After the Toddler Dose
n=132 Participants
Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
|
7vPnC/13vPnC Before Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with Pentavac at 2, 3, and 4 months of age (infant series). Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Pentavac at 12 months of age (toddler dose).
|
7vPnC/13vPnC After Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with Pentavac at 2, 3, and 4 months of age (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with Pentavac at 12 months of age (toddler dose), assessment made at 13 months of age.
|
13vPnC/13vPnC Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose).
|
7vPnC/7vPnC Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose).
|
7vPnC/13vPnC Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose).
|
|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Concentration (GMC) for Haemophilus Influenzae Type b (Hib) in 13vPnC Group Relative to 7vPnC Group
|
1.28 μg/mL
Interval 1.1 to 1.49
|
1.40 μg/mL
Interval 1.19 to 1.64
|
12.15 μg/mL
Interval 10.54 to 14.0
|
11.68 μg/mL
Interval 9.66 to 14.13
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: One month after the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age)Population: Evaluable immunogenicity (per protocol) population adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.
Outcome measures
| Measure |
13vPnC After the Infant Series
n=258 Participants
Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
|
7vPnC After the Infant Series
n=256 Participants
Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
|
13vPnC After the Toddler Dose
n=239 Participants
Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
|
7vPnC After the Toddler Dose
n=129 Participants
Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
|
7vPnC/13vPnC Before Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with Pentavac at 2, 3, and 4 months of age (infant series). Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Pentavac at 12 months of age (toddler dose).
|
7vPnC/13vPnC After Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with Pentavac at 2, 3, and 4 months of age (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with Pentavac at 12 months of age (toddler dose), assessment made at 13 months of age.
|
13vPnC/13vPnC Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose).
|
7vPnC/7vPnC Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose).
|
7vPnC/13vPnC Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose).
|
|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Concentration (GMC) as Measured by Enzyme-linked Immunosorbent Assay (ELISA) for Poliomyelitis (Type 1, Type 2 and Type 3) in 13vPnC Group Relative to 7vPnC Group
Polio Type 1
|
24.99 titer
Interval 21.37 to 29.23
|
28.33 titer
Interval 24.4 to 32.89
|
253.05 titer
Interval 207.15 to 309.11
|
250.56 titer
Interval 193.17 to 324.99
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) as Measured by Enzyme-linked Immunosorbent Assay (ELISA) for Poliomyelitis (Type 1, Type 2 and Type 3) in 13vPnC Group Relative to 7vPnC Group
Polio Type 2
|
17.75 titer
Interval 15.07 to 20.92
|
21.55 titer
Interval 18.43 to 25.2
|
408.34 titer
Interval 338.94 to 491.95
|
415.20 titer
Interval 325.57 to 529.52
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) as Measured by Enzyme-linked Immunosorbent Assay (ELISA) for Poliomyelitis (Type 1, Type 2 and Type 3) in 13vPnC Group Relative to 7vPnC Group
Polio Type 3
|
41.08 titer
Interval 34.08 to 49.52
|
52.95 titer
Interval 43.26 to 64.82
|
536.32 titer
Interval 436.46 to 659.02
|
638.18 titer
Interval 501.5 to 812.13
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: One month after the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age)Population: Evaluable immunogenicity (per protocol) population adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.
Outcome measures
| Measure |
13vPnC After the Infant Series
n=263 Participants
Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
|
7vPnC After the Infant Series
n=262 Participants
Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
|
13vPnC After the Toddler Dose
n=239 Participants
Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
|
7vPnC After the Toddler Dose
n=133 Participants
Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
|
7vPnC/13vPnC Before Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with Pentavac at 2, 3, and 4 months of age (infant series). Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Pentavac at 12 months of age (toddler dose).
|
7vPnC/13vPnC After Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with Pentavac at 2, 3, and 4 months of age (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with Pentavac at 12 months of age (toddler dose), assessment made at 13 months of age.
|
13vPnC/13vPnC Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose).
|
7vPnC/7vPnC Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose).
|
7vPnC/13vPnC Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose).
|
|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Concentration (GMC) as Measured by ELISA for Pertussis Toxin (PT) and Pertussis Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group
Pertussis - FHA
|
97.12 EU/mL
Interval 89.84 to 104.98
|
111.23 EU/mL
Interval 102.8 to 120.35
|
204.28 EU/mL
Interval 185.65 to 224.79
|
241.08 EU/mL
Interval 210.92 to 275.55
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) as Measured by ELISA for Pertussis Toxin (PT) and Pertussis Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group
Pertussis - PT
|
62.94 EU/mL
Interval 58.8 to 67.38
|
68.20 EU/mL
Interval 63.6 to 73.14
|
61.09 EU/mL
Interval 56.19 to 66.4
|
61.70 EU/mL
Interval 54.55 to 69.78
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: One month after the 3-Dose Infant Series (at 5 months of age)Population: Evaluable immunogenicity (per protocol) population adhered to the protocol requirements, 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 After the Infant Series
n=266 Participants
Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
|
7vPnC After the Infant Series
Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
|
13vPnC After the Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
|
7vPnC After the Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
|
7vPnC/13vPnC Before Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with Pentavac at 2, 3, and 4 months of age (infant series). Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Pentavac at 12 months of age (toddler dose).
|
7vPnC/13vPnC After Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with Pentavac at 2, 3, and 4 months of age (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with Pentavac at 12 months of age (toddler dose), assessment made at 13 months of age.
|
13vPnC/13vPnC Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose).
|
7vPnC/7vPnC Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose).
|
7vPnC/13vPnC Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose).
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the 3-Dose Infant Series of 13vPnC
Common Serotypes - Serotype 14 (n=236)
|
94.9 percentage of participants
Interval 91.3 to 97.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the 3-Dose Infant Series of 13vPnC
Common Serotypes - Serotype 4 (n=244)
|
91.4 percentage of participants
Interval 87.1 to 94.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the 3-Dose Infant Series of 13vPnC
Common Serotypes - Serotype 6B (n=241)
|
72.6 percentage of participants
Interval 66.5 to 78.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the 3-Dose Infant Series of 13vPnC
Common Serotypes - Serotype 9V (n=238)
|
92.9 percentage of participants
Interval 88.8 to 95.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the 3-Dose Infant Series of 13vPnC
Common Serotypes - Serotype 18C (n=242)
|
90.5 percentage of participants
Interval 86.1 to 93.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the 3-Dose Infant Series of 13vPnC
Common Serotypes - Serotype 19F (n=241)
|
97.9 percentage of participants
Interval 95.2 to 99.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the 3-Dose Infant Series of 13vPnC
Common Serotypes - Serotype 23F (n=244)
|
82.8 percentage of participants
Interval 77.5 to 87.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the 3-Dose Infant Series of 13vPnC
Additional Serotypes - Serotype 1 (n=240)
|
90.8 percentage of participants
Interval 86.5 to 94.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the 3-Dose Infant Series of 13vPnC
Additional Serotypes - Serotype 3 (n=242)
|
96.3 percentage of participants
Interval 93.1 to 98.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the 3-Dose Infant Series of 13vPnC
Additional Serotypes - Serotype 5 (n=243)
|
84.0 percentage of participants
Interval 78.7 to 88.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the 3-Dose Infant Series of 13vPnC
Additional Serotypes - Serotype 6A (n=243)
|
85.6 percentage of participants
Interval 80.5 to 89.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the 3-Dose Infant Series of 13vPnC
Additional Serotypes - Serotype 7F (n=238)
|
97.5 percentage of participants
Interval 94.6 to 99.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the 3-Dose Infant Series of 13vPnC
Additional Serotypes - Serotype 19A (n=244)
|
97.5 percentage of participants
Interval 94.7 to 99.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: During the 4-day period 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 (Tender)was scaled as Any (tenderness present); Significant (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 (2.5 to 7.0 cm); Severe (Sev) (\>7.0 cm). Participants may be represented in more than 1 category.
Outcome measures
| Measure |
13vPnC After the Infant Series
n=302 Participants
Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
|
7vPnC After the Infant Series
n=309 Participants
Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
|
13vPnC After the Toddler Dose
n=302 Participants
Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
|
7vPnC After the Toddler Dose
n=309 Participants
Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
|
7vPnC/13vPnC Before Toddler Dose
n=302 Participants
Participants received one single 0.5 mL dose of 7vPnC coadministered with Pentavac at 2, 3, and 4 months of age (infant series). Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Pentavac at 12 months of age (toddler dose).
|
7vPnC/13vPnC After Toddler Dose
n=309 Participants
Participants received one single 0.5 mL dose of 7vPnC coadministered with Pentavac at 2, 3, and 4 months of age (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with Pentavac at 12 months of age (toddler dose), assessment made at 13 months of age.
|
13vPnC/13vPnC Toddler Dose
n=273 Participants
Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose).
|
7vPnC/7vPnC Toddler Dose
n=152 Participants
Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose).
|
7vPnC/13vPnC Toddler Dose
n=137 Participants
Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose).
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Reporting Pre-Specified Local Reactions
Tender-Any (n=256,257,223,225,210,206,189,96,89)
|
38.3 Percentage of Participants
|
38.5 Percentage of Participants
|
33.2 Percentage of Participants
|
42.2 Percentage of Participants
|
36.2 Percentage of Participants
|
32.0 Percentage of Participants
|
50.3 Percentage of Participants
|
44.8 Percentage of Participants
|
64.0 Percentage of Participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions
Tender-Sig (n=237,245,203,208,188,193,155,86,75)
|
5.5 Percentage of Participants
|
4.9 Percentage of Participants
|
5.4 Percentage of Participants
|
6.7 Percentage of Participants
|
3.7 Percentage of Participants
|
3.1 Percentage of Participants
|
5.2 Percentage of Participants
|
4.7 Percentage of Participants
|
8.0 Percentage of Participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions
Swelling-Sev (n=235,244,199,203,184,188,152,87,73)
|
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
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions
Swelling-Mild(n=249,255,223,232,213,214,181,99,95)
|
36.9 Percentage of Participants
|
35.7 Percentage of Participants
|
46.6 Percentage of Participants
|
51.3 Percentage of Participants
|
44.6 Percentage of Participants
|
45.8 Percentage of Participants
|
48.1 Percentage of Participants
|
55.6 Percentage of Participants
|
57.9 Percentage of Participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions
Swelling-Any (n=254,256,226,235,217,219,185,99,97)
|
41.3 Percentage of Participants
|
38.7 Percentage of Participants
|
50.0 Percentage of Participants
|
54.5 Percentage of Participants
|
48.4 Percentage of Participants
|
51.1 Percentage of Participants
|
53.5 Percentage of Participants
|
57.6 Percentage of Participants
|
59.8 Percentage of Participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions
Swelling-Mod (n=243,246,207,208,193,194,159,88,82)
|
14.4 Percentage of Participants
|
9.3 Percentage of Participants
|
14.0 Percentage of Participants
|
14.4 Percentage of Participants
|
14.0 Percentage of Participants
|
16.0 Percentage of Participants
|
19.5 Percentage of Participants
|
15.9 Percentage of Participants
|
20.7 Percentage of Participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions
Redness-Any (n=256,260,236,241,226,223,187,106,99)
|
44.5 Percentage of Participants
|
46.9 Percentage of Participants
|
53.4 Percentage of Participants
|
58.1 Percentage of Participants
|
55.8 Percentage of Participants
|
59.2 Percentage of Participants
|
66.8 Percentage of Participants
|
60.4 Percentage of Participants
|
63.6 Percentage of Participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions
Redness-Mild(n=252,259,234,240,223,221,180,106,95)
|
40.9 Percentage of Participants
|
45.6 Percentage of Participants
|
50.9 Percentage of Participants
|
56.7 Percentage of Participants
|
52.5 Percentage of Participants
|
55.7 Percentage of Participants
|
60.0 Percentage of Participants
|
54.7 Percentage of Participants
|
60.0 Percentage of Participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions
Redness-Mod (n=241,245,205,206,190,192,165,87,79)
|
9.5 Percentage of Participants
|
3.7 Percentage of Participants
|
7.3 Percentage of Participants
|
6.8 Percentage of Participants
|
8.9 Percentage of Participants
|
12.5 Percentage of Participants
|
24.2 Percentage of Participants
|
18.4 Percentage of Participants
|
20.3 Percentage of Participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions
Redness-Sev (n=234,244,199,203,184,188,152,86,73)
|
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
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
PRIMARY outcome
Timeframe: During the 4-day period 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 \[med\] 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 After the Infant Series
n=302 Participants
Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
|
7vPnC After the Infant Series
n=309 Participants
Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
|
13vPnC After the Toddler Dose
n=302 Participants
Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
|
7vPnC After the Toddler Dose
n=309 Participants
Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
|
7vPnC/13vPnC Before Toddler Dose
n=302 Participants
Participants received one single 0.5 mL dose of 7vPnC coadministered with Pentavac at 2, 3, and 4 months of age (infant series). Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Pentavac at 12 months of age (toddler dose).
|
7vPnC/13vPnC After Toddler Dose
n=309 Participants
Participants received one single 0.5 mL dose of 7vPnC coadministered with Pentavac at 2, 3, and 4 months of age (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with Pentavac at 12 months of age (toddler dose), assessment made at 13 months of age.
|
13vPnC/13vPnC Toddler Dose
n=273 Participants
Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose).
|
7vPnC/7vPnC Toddler Dose
n=152 Participants
Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose).
|
7vPnC/13vPnC Toddler Dose
n=137 Participants
Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose).
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Reporting Pre-Specified Systemic Events
Fv≥38°C,≤39°C(n=244,250,212,217,201,208,174,99,83)
|
13.5 Percentage of Participants
|
10.0 Percentage of Participants
|
19.8 Percentage of Participants
|
25.3 Percentage of Participants
|
26.9 Percentage of Participants
|
27.9 Percentage of Participants
|
36.8 Percentage of Participants
|
41.4 Percentage of Participants
|
42.2 Percentage of Participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events
Fv >40°C (n=238,245,200,205,184,190,153,88,73)
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.5 Percentage of Participants
|
0.0 Percentage of Participants
|
0.7 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events
Decr appetite(n=243,251,211,218,194,199,167,96,83)
|
24.7 Percentage of Participants
|
23.1 Percentage of Participants
|
18.5 Percentage of Participants
|
26.1 Percentage of Participants
|
23.2 Percentage of Participants
|
21.1 Percentage of Participants
|
29.3 Percentage of Participants
|
34.4 Percentage of Participants
|
31.3 Percentage of Participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events
Irritability (n=261,265,232,238,217,211,178,99,91)
|
54.4 Percentage of Participants
|
52.5 Percentage of Participants
|
48.3 Percentage of Participants
|
49.6 Percentage of Participants
|
41.9 Percentage of Participants
|
40.3 Percentage of Participants
|
50.6 Percentage of Participants
|
46.5 Percentage of Participants
|
50.5 Percentage of Participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events
Incr sleep (n=256,259,215,227,194,204,163,92,81)
|
34.0 Percentage of Participants
|
41.3 Percentage of Participants
|
28.4 Percentage of Participants
|
32.2 Percentage of Participants
|
23.7 Percentage of Participants
|
28.4 Percentage of Participants
|
21.5 Percentage of Participants
|
23.9 Percentage of Participants
|
23.5 Percentage of Participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events
Decr sleep (n=246,253,,215,218,203,196,168,93,81)
|
28.0 Percentage of Participants
|
20.6 Percentage of Participants
|
26.5 Percentage of Participants
|
27.1 Percentage of Participants
|
25.1 Percentage of Participants
|
20.9 Percentage of Participants
|
26.2 Percentage of Participants
|
22.6 Percentage of Participants
|
30.9 Percentage of Participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events
Med-prevent sx(n=252,260,221,236,201,213,181,99,85
|
34.5 Percentage of Participants
|
34.6 Percentage of Participants
|
36.7 Percentage of Participants
|
40.3 Percentage of Participants
|
28.4 Percentage of Participants
|
37.6 Percentage of Participants
|
38.7 Percentage of Participants
|
44.4 Percentage of Participants
|
40.0 Percentage of Participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events
Fv>39°C,≤40°C(n=238,245,201,205,184,191,153,89,73)
|
0.8 Percentage of Participants
|
0.4 Percentage of Participants
|
1.0 Percentage of Participants
|
2.4 Percentage of Participants
|
0.5 Percentage of Participants
|
1.6 Percentage of Participants
|
4.6 Percentage of Participants
|
2.2 Percentage of Participants
|
4.1 Percentage of Participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events
Med-treat sx(n=248,259,224,227,202,214,180,100,89)
|
29.0 Percentage of Participants
|
32.8 Percentage of Participants
|
38.4 Percentage of Participants
|
44.5 Percentage of Participants
|
36.1 Percentage of Participants
|
42.1 Percentage of Participants
|
47.8 Percentage of Participants
|
54.0 Percentage of Participants
|
55.1 Percentage of Participants
|
PRIMARY outcome
Timeframe: One month after the 3-Dose Infant Series (at 5 months of age)Population: The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the 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 serotype.
Antibody GMC for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated.
Outcome measures
| Measure |
13vPnC After the Infant Series
n=266 Participants
Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
|
7vPnC After the Infant Series
Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
|
13vPnC After the Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
|
7vPnC After the Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
|
7vPnC/13vPnC Before Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with Pentavac at 2, 3, and 4 months of age (infant series). Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Pentavac at 12 months of age (toddler dose).
|
7vPnC/13vPnC After Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with Pentavac at 2, 3, and 4 months of age (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with Pentavac at 12 months of age (toddler dose), assessment made at 13 months of age.
|
13vPnC/13vPnC Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose).
|
7vPnC/7vPnC Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose).
|
7vPnC/13vPnC Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose).
|
|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the 3-Dose Infant Series of 13vPnC
Common Serotypes - Serotype 23F (n=244)
|
0.92 μg/mL
Interval 0.8 to 1.06
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the 3-Dose Infant Series of 13vPnC
Additional Serotypes - Serotype 1 (n=240)
|
1.21 μg/mL
Interval 1.07 to 1.38
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the 3-Dose Infant Series of 13vPnC
Additional Serotypes - Serotype 5 (n=243)
|
0.93 μg/mL
Interval 0.82 to 1.06
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the 3-Dose Infant Series of 13vPnC
Common Serotypes - Serotype 4 (n=244)
|
1.29 μg/mL
Interval 1.14 to 1.46
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the 3-Dose Infant Series of 13vPnC
Common Serotypes - Serotype 6B (n=241)
|
0.74 μg/mL
Interval 0.62 to 0.89
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the 3-Dose Infant Series of 13vPnC
Common Serotypes - Serotype 9V (n=238)
|
1.15 μg/mL
Interval 1.03 to 1.28
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the 3-Dose Infant Series of 13vPnC
Common Serotypes - Serotype 14 (n=236)
|
2.74 μg/mL
Interval 2.38 to 3.16
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the 3-Dose Infant Series of 13vPnC
Common Serotypes - Serotype 18C (n=242)
|
1.42 μg/mL
Interval 1.26 to 1.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the 3-Dose Infant Series of 13vPnC
Common Serotypes - Serotype 19F (n=241)
|
1.55 μg/mL
Interval 1.42 to 1.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the 3-Dose Infant Series of 13vPnC
Additional Serotypes - Serotype 3 (n=242)
|
1.25 μg/mL
Interval 1.13 to 1.37
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the 3-Dose Infant Series of 13vPnC
Additional Serotypes - Serotype 6A (n=243)
|
0.94 μg/mL
Interval 0.82 to 1.06
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the 3-Dose Infant Series of 13vPnC
Additional Serotypes - Serotype 7F (n=238)
|
1.93 μg/mL
Interval 1.73 to 2.15
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the 3-Dose Infant Series of 13vPnC
Additional Serotypes - Serotype 19A (n=244)
|
2.10 μg/mL
Interval 1.87 to 2.35
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: One month after the toddler dose (at 13 months of age)Population: Evaluable immunogenicity (per protocol) population who adhered to the 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 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 After the Infant Series
n=241 Participants
Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
|
7vPnC After the Infant Series
n=133 Participants
Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
|
13vPnC After the Toddler Dose
n=121 Participants
Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
|
7vPnC After the Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
|
7vPnC/13vPnC Before Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with Pentavac at 2, 3, and 4 months of age (infant series). Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Pentavac at 12 months of age (toddler dose).
|
7vPnC/13vPnC After Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with Pentavac at 2, 3, and 4 months of age (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with Pentavac at 12 months of age (toddler dose), assessment made at 13 months of age.
|
13vPnC/13vPnC Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose).
|
7vPnC/7vPnC Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose).
|
7vPnC/13vPnC Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose).
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups
Additional Serotypes - Serotype 7F (n=234,124,110)
|
100.0 percentage of participants
Interval 98.4 to 100.0
|
7.3 percentage of participants
Interval 3.4 to 13.3
|
100.0 percentage of participants
Interval 96.7 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups
Common Serotypes - Serotype 14 (n=233,135,111)
|
99.6 percentage of participants
Interval 97.6 to 100.0
|
100.0 percentage of participants
Interval 97.1 to 100.0
|
99.1 percentage of participants
Interval 95.1 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups
Common Serotypes - Serotype 4 (n=233,126,111)
|
100.0 percentage of participants
Interval 98.4 to 100.0
|
100.0 percentage of participants
Interval 97.1 to 100.0
|
99.1 percentage of participants
Interval 95.1 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups
Common Serotypes - Serotype 6B (n=233,126,108)
|
99.6 percentage of participants
Interval 97.6 to 100.0
|
99.2 percentage of participants
Interval 95.7 to 100.0
|
98.1 percentage of participants
Interval 93.5 to 99.8
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups
Common Serotypes - Serotype 9V (n=232,124,109)
|
100.0 percentage of participants
Interval 98.4 to 100.0
|
100.0 percentage of participants
Interval 97.1 to 100.0
|
100.0 percentage of participants
Interval 96.7 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups
Common Serotypes - Serotype 18C (n=230,125,113)
|
99.6 percentage of participants
Interval 97.6 to 100.0
|
99.2 percentage of participants
Interval 95.6 to 100.0
|
98.2 percentage of participants
Interval 93.8 to 99.8
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups
Common Serotypes - Serotype 19F (n=233,126,112)
|
97.9 percentage of participants
Interval 95.1 to 99.3
|
97.6 percentage of participants
Interval 93.2 to 99.5
|
97.3 percentage of participants
Interval 92.4 to 99.4
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups
Common Serotypes - Serotype 23F (n=232,123,111)
|
99.6 percentage of participants
Interval 97.6 to 100.0
|
99.2 percentage of participants
Interval 95.6 to 100.0
|
99.1 percentage of participants
Interval 95.1 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups
Additional Serotypes - Serotype 1 (n=233,119,112)
|
100.0 percentage of participants
Interval 98.4 to 100.0
|
0.8 percentage of participants
Interval 0.0 to 4.6
|
95.5 percentage of participants
Interval 89.9 to 98.5
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups
Additional Serotypes - Serotype 3 (n=233,124,113)
|
94.8 percentage of participants
Interval 91.2 to 97.3
|
13.7 percentage of participants
Interval 8.2 to 21.0
|
93.8 percentage of participants
Interval 87.7 to 97.5
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups
Additional Serotypes - Serotype 5 (n=236,111,111)
|
100.0 percentage of participants
Interval 98.4 to 100.0
|
73.0 percentage of participants
Interval 63.7 to 81.0
|
90.1 percentage of participants
Interval 83.0 to 94.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups
Additional Serotypes - Serotype 6A (n=235,124,109)
|
100.0 percentage of participants
Interval 98.4 to 100.0
|
89.5 percentage of participants
Interval 82.7 to 94.3
|
89.9 percentage of participants
Interval 82.7 to 94.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups
Additional Serotypes - Serotype 19A(n=233,127,112)
|
100.0 percentage of participants
Interval 98.4 to 100.0
|
100.0 percentage of participants
Interval 97.1 to 100.0
|
100.0 percentage of participants
Interval 96.8 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: One month after the Toddler Dose (at 13 months of age)Population: The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.
Antibody GMC as measured by ELISA for 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
Outcome measures
| Measure |
13vPnC After the Infant Series
n=241 Participants
Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
|
7vPnC After the Infant Series
n=241 Participants
Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
|
13vPnC After the Toddler Dose
n=133 Participants
Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
|
7vPnC After the Toddler Dose
n=133 Participants
Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
|
7vPnC/13vPnC Before Toddler Dose
n=121 Participants
Participants received one single 0.5 mL dose of 7vPnC coadministered with Pentavac at 2, 3, and 4 months of age (infant series). Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Pentavac at 12 months of age (toddler dose).
|
7vPnC/13vPnC After Toddler Dose
n=121 Participants
Participants received one single 0.5 mL dose of 7vPnC coadministered with Pentavac at 2, 3, and 4 months of age (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with Pentavac at 12 months of age (toddler dose), assessment made at 13 months of age.
|
13vPnC/13vPnC Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose).
|
7vPnC/7vPnC Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose).
|
7vPnC/13vPnC Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose).
|
|---|---|---|---|---|---|---|---|---|---|
|
Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups
Additional-Serotype 6A (n=238,235,122,124,116,109)
|
0.9 μg/mL
Interval 0.8 to 1.0
|
6.1 μg/mL
Interval 5.5 to 6.8
|
0.4 μg/mL
Interval 0.3 to 0.5
|
1.5 μg/mL
Interval 1.3 to 1.9
|
0.4 μg/mL
Interval 0.3 to 0.4
|
2.6 μg/mL
Interval 2.0 to 3.4
|
—
|
—
|
—
|
|
Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups
Common - Serotype 4 (n=239,233,131,126,118,111)
|
0.3 μg/mL
Interval 0.3 to 0.3
|
4.2 μg/mL
Interval 3.8 to 4.7
|
0.5 μg/mL
Interval 0.4 to 0.5
|
4.8 μg/mL
Interval 4.2 to 5.6
|
0.5 μg/mL
Interval 0.4 to 0.5
|
4.0 μg/mL
Interval 3.4 to 4.8
|
—
|
—
|
—
|
|
Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups
Common - Serotype 6B (n=235,233,131,126,115,108)
|
1.0 μg/mL
Interval 0.9 to 1.1
|
9.0 μg/mL
Interval 8.0 to 10.1
|
1.1 μg/mL
Interval 0.9 to 1.3
|
9.6 μg/mL
Interval 8.3 to 11.2
|
0.9 μg/mL
Interval 0.8 to 1.1
|
10.3 μg/mL
Interval 8.2 to 13.0
|
—
|
—
|
—
|
|
Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups
Common - Serotype 9V (n=239,232,131,124,118,109)
|
0.4 μg/mL
Interval 0.4 to 0.5
|
2.3 μg/mL
Interval 2.3 to 2.8
|
0.5 μg/mL
Interval 0.5 to 0.6
|
3.2 μg/mL
Interval 2.8 to 3.7
|
0.4 μg/mL
Interval 0.4 to 0.5
|
2.3 μg/mL
Interval 2.0 to 2.6
|
—
|
—
|
—
|
|
Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups
Common - Serotype 14 (n=238,233,131,125,118,111)
|
2.0 μg/mL
Interval 1.8 to 2.3
|
9.5 μg/mL
Interval 8.5 to 10.6
|
2.4 μg/mL
Interval 2.1 to 2.9
|
10.8 μg/mL
Interval 9.4 to 12.5
|
2.4 μg/mL
Interval 2.0 to 3.0
|
7.8 μg/mL
Interval 6.6 to 9.3
|
—
|
—
|
—
|
|
Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups
Common - Serotype 18C (n=239,230,131,125,118,113)
|
0.3 μg/mL
Interval 0.3 to 0.3
|
2.3 μg/mL
Interval 2.1 to 2.5
|
0.3 μg/mL
Interval 0.3 to 0.4
|
2.8 μg/mL
Interval 2.5 to 3.2
|
0.3 μg/mL
Interval 0.3 to 0.4
|
2.4 μg/mL
Interval 2.0 to 2.9
|
—
|
—
|
—
|
|
Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups
Common - Serotype 19F (n=239,233,130,126,118,112)
|
0.7 μg/mL
Interval 0.6 to 0.7
|
5.2 μg/mL
Interval 4.5 to 6.0
|
0.7 μg/mL
Interval 0.6 to 0.9
|
4.1 μg/mL
Interval 3.4 to 5.0
|
0.6 μg/mL
Interval 0.5 to 0.7
|
3.7 μg/mL
Interval 3.0 to 4.6
|
—
|
—
|
—
|
|
Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups
Common - Serotype 23F (n=237,232,130,123,118,111)
|
0.3 μg/mL
Interval 0.2 to 0.3
|
3.0 μg/mL
Interval 2.7 to 3.4
|
0.3 μg/mL
Interval 0.3 to 0.4
|
3.7 μg/mL
Interval 3.1 to 4.3
|
0.3 μg/mL
Interval 0.2 to 0.4
|
3.1 μg/mL
Interval 2.6 to 3.7
|
—
|
—
|
—
|
|
Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups
Additional-Serotype 1 (n=239,233,128,119,116,112)
|
0.4 μg/mL
Interval 0.4 to 0.5
|
4.1 μg/mL
Interval 3.7 to 4.5
|
0.0 μg/mL
Interval 0.0 to 0.0
|
0.0 μg/mL
Interval 0.0 to 0.0
|
0.0 μg/mL
Interval 0.0 to 0.0
|
1.8 μg/mL
Interval 1.5 to 2.2
|
—
|
—
|
—
|
|
Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups
Additional-Serotype 3 (n=232,233,128,124,115,113)
|
0.2 μg/mL
Interval 0.2 to 0.2
|
1.0 μg/mL
Interval 0.9 to 1.1
|
0.1 μg/mL
Interval 0.1 to 0.1
|
0.1 μg/mL
Interval 0.1 to 0.1
|
0.1 μg/mL
Interval 0.1 to 0.1
|
1.3 μg/mL
Interval 1.1 to 1.5
|
—
|
—
|
—
|
|
Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups
Additional-Serotype 5 (n=236,236,128,124,115,113)
|
0.8 μg/mL
Interval 0.7 to 0.9
|
3.3 μg/mL
Interval 3.0 to 3.7
|
0.4 μg/mL
Interval 0.4 to 0.5
|
0.5 μg/mL
Interval 0.4 to 0.6
|
0.4 μg/mL
Interval 0.4 to 0.5
|
1.1 μg/mL
Interval 1.0 to 1.3
|
—
|
—
|
—
|
|
Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups
Additional-Serotype 7F (n=239,234,131,124,117,110)
|
0.8 μg/mL
Interval 0.7 to 0.9
|
4.5 μg/mL
Interval 4.1 to 5.0
|
0.1 μg/mL
Interval 0.0 to 0.1
|
0.1 μg/mL
Interval 0.0 to 0.1
|
0.1 μg/mL
Interval 0.1 to 0.1
|
3.7 μg/mL
Interval 3.2 to 4.3
|
—
|
—
|
—
|
|
Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups
Additional-Serotype 19A(n=237,233,131,127,117,112)
|
1.5 μg/mL
Interval 1.3 to 1.7
|
9.5 μg/mL
Interval 8.5 to 10.6
|
1.1 μg/mL
Interval 0.9 to 1.3
|
4.0 μg/mL
Interval 3.5 to 4.5
|
0.9 μg/mL
Interval 0.7 to 1.1
|
5.3 μg/mL
Interval 4.6 to 6.2
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: One month after the toddler dose (at 13 months of age)Population: The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.
Percentage of participants achieving functional antibody titer ≥1:8 as measured by opsonophagocytic activity assay (OPA) along with the corresponding 95% CI for the 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
Outcome measures
| Measure |
13vPnC After the Infant Series
n=241 Participants
Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
|
7vPnC After the Infant Series
n=121 Participants
Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
|
13vPnC After the Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
|
7vPnC After the Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
|
7vPnC/13vPnC Before Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with Pentavac at 2, 3, and 4 months of age (infant series). Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Pentavac at 12 months of age (toddler dose).
|
7vPnC/13vPnC After Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with Pentavac at 2, 3, and 4 months of age (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with Pentavac at 12 months of age (toddler dose), assessment made at 13 months of age.
|
13vPnC/13vPnC Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose).
|
7vPnC/7vPnC Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose).
|
7vPnC/13vPnC Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose).
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Antibody Titer ≥1:8 After the Toddler Dose in 13vPnC/13vPnC and 7vPnC/13vPnC Groups
Additional Serotypes - Serotype 5
|
100.0 Percentage of Participants
Interval 95.9 to 100.0
|
97.8 Percentage of Participants
Interval 92.2 to 99.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Titer ≥1:8 After the Toddler Dose in 13vPnC/13vPnC and 7vPnC/13vPnC Groups
Additional Serotypes - Serotype 6A
|
100.0 Percentage of Participants
Interval 95.8 to 100.0
|
98.9 Percentage of Participants
Interval 94.0 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Titer ≥1:8 After the Toddler Dose in 13vPnC/13vPnC and 7vPnC/13vPnC Groups
Additional Serotypes - Serotype 7F
|
100.0 Percentage of Participants
Interval 95.8 to 100.0
|
100.0 Percentage of Participants
Interval 95.9 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Titer ≥1:8 After the Toddler Dose in 13vPnC/13vPnC and 7vPnC/13vPnC Groups
Additional Serotypes - Serotype 1
|
100.0 Percentage of Participants
Interval 95.9 to 100.0
|
98.9 Percentage of Participants
Interval 94.0 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Titer ≥1:8 After the Toddler Dose in 13vPnC/13vPnC and 7vPnC/13vPnC Groups
Additional Serotypes - Serotype 3
|
100.0 Percentage of Participants
Interval 95.9 to 100.0
|
97.8 Percentage of Participants
Interval 92.2 to 99.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Titer ≥1:8 After the Toddler Dose in 13vPnC/13vPnC and 7vPnC/13vPnC Groups
Additional Serotypes - Serotype 19A
|
98.8 Percentage of Participants
Interval 93.7 to 100.0
|
97.8 Percentage of Participants
Interval 92.2 to 99.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: One month after the toddler dose (at 13 months of age)Population: The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.
GMT as measured by opsonophagocytic activity assay (OPA) for 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
Outcome measures
| Measure |
13vPnC After the Infant Series
n=241 Participants
Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
|
7vPnC After the Infant Series
n=121 Participants
Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
|
13vPnC After the Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
|
7vPnC After the Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
|
7vPnC/13vPnC Before Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with Pentavac at 2, 3, and 4 months of age (infant series). Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Pentavac at 12 months of age (toddler dose).
|
7vPnC/13vPnC After Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with Pentavac at 2, 3, and 4 months of age (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with Pentavac at 12 months of age (toddler dose), assessment made at 13 months of age.
|
13vPnC/13vPnC Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose).
|
7vPnC/7vPnC Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose).
|
7vPnC/13vPnC Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose).
|
|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Titer (GMT) in 13vPnC/13vPnC and 7vPnC/13vPnC Groups After the Toddler Dose
Additional Serotypes - Serotype 1
|
126.00 titer
Interval 99.87 to 158.97
|
61.58 titer
Interval 47.72 to 79.47
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titer (GMT) in 13vPnC/13vPnC and 7vPnC/13vPnC Groups After the Toddler Dose
Additional Serotypes - Serotype 3
|
345.33 titer
Interval 296.06 to 402.8
|
428.88 titer
Interval 346.69 to 530.56
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titer (GMT) in 13vPnC/13vPnC and 7vPnC/13vPnC Groups After the Toddler Dose
Additional Serotypes - Serotype 5
|
244.18 titer
Interval 200.14 to 297.92
|
130.99 titer
Interval 103.68 to 165.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titer (GMT) in 13vPnC/13vPnC and 7vPnC/13vPnC Groups After the Toddler Dose
Additional Serotypes - Serotype 6A
|
1346.83 titer
Interval 1143.98 to 1585.65
|
891.44 titer
Interval 694.76 to 1143.81
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titer (GMT) in 13vPnC/13vPnC and 7vPnC/13vPnC Groups After the Toddler Dose
Additional Serotypes - Serotype 7F
|
8126.24 titer
Interval 6657.36 to 9919.21
|
17034.59 titer
Interval 14316.59 to 20268.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titer (GMT) in 13vPnC/13vPnC and 7vPnC/13vPnC Groups After the Toddler Dose
Additional Serotypes - Serotype 19A
|
804.06 titer
Interval 615.9 to 1049.71
|
1072.43 titer
Interval 799.06 to 1439.32
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
13vPnC Infant Series
Serious events: 5 serious events
Other events: 142 other events
Deaths: 0 deaths
7vPnC Infant Series
Serious events: 5 serious events
Other events: 162 other events
Deaths: 0 deaths
13vPnC Post-Infant Series
Serious events: 8 serious events
Other events: 12 other events
Deaths: 0 deaths
7vPnC Post-Infant Series
Serious events: 5 serious events
Other events: 11 other events
Deaths: 0 deaths
13vPnC/13vPnC Toddler Dose
Serious events: 2 serious events
Other events: 125 other events
Deaths: 0 deaths
7vPnC/7vPnC Toddler Dose
Serious events: 0 serious events
Other events: 64 other events
Deaths: 0 deaths
7vPnC/ 13vPnC Toddler Dose
Serious events: 2 serious events
Other events: 63 other events
Deaths: 0 deaths
13vPnC / 13vPnC 6-Month Follow-up
Serious events: 6 serious events
Other events: 2 other events
Deaths: 0 deaths
7vPnC / 7vPnC 6-Month Follow-up
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
7vPnC / 13vPnC 6-Month Follow-up
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
13vPnC Infant Series
n=304 participants at risk
Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series). Adverse events were collected from dose 1 to approximately one month after dose 3.
|
7vPnC Infant Series
n=309 participants at risk
Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series). Adverse events were collected from dose 1 to approximately one month after dose 3.
|
13vPnC Post-Infant Series
n=290 participants at risk
Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series). Adverse events were collected from approximately one month after dose 3 to toddler dose.
|
7vPnC Post-Infant Series
n=299 participants at risk
Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series). Adverse events were collected from approximately one month after dose 3 to toddler dose.
|
13vPnC/13vPnC Toddler Dose
n=272 participants at risk；n=273 participants at risk
Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose). Adverse events were collected for approximately one month after toddler dose.
|
7vPnC/7vPnC Toddler Dose
n=152 participants at risk
Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose). Adverse events were collected for approximately one month after toddler dose.
|
7vPnC/ 13vPnC Toddler Dose
n=137 participants at risk；n=134 participants at risk
Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose). Adverse events were collected for approximately one month after toddler dose.
|
13vPnC / 13vPnC 6-Month Follow-up
n=267 participants at risk
Participants received one single 0.5 mL dose of 13vPnC coadministered with Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler). Adverse events were collected for approximately six months after last visit.
|
7vPnC / 7vPnC 6-Month Follow-up
n=150 participants at risk
Participants received one single 0.5 mL dose of 7vPnC coadministered with Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler). Adverse events were collected for approximately six months after last visit.
|
7vPnC / 13vPnC 6-Month Follow-up
n=133 participants at risk
Participants received one single 0.5 mL dose of 7vPnC coadministered with Pentavac at 2, 3, and 4 months of age (infant series) and at 12 months of age (toddler). Adverse events were collected for approximately six months after last visit.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/304
|
0.32%
1/309
|
0.00%
0/290
|
0.00%
0/299
|
0.00%
0/273
|
0.00%
0/152
|
0.00%
0/134
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/304
|
0.00%
0/309
|
0.34%
1/290
|
0.00%
0/299
|
0.00%
0/273
|
0.00%
0/152
|
0.00%
0/134
|
0.00%
0/267
|
0.67%
1/150
|
0.00%
0/133
|
|
Infections and infestations
Bronchiolitis
|
0.66%
2/304
|
0.32%
1/309
|
0.34%
1/290
|
0.00%
0/299
|
0.00%
0/273
|
0.00%
0/152
|
0.75%
1/134
|
0.00%
0/267
|
0.67%
1/150
|
0.00%
0/133
|
|
Infections and infestations
Bronchitis
|
0.00%
0/304
|
0.00%
0/309
|
0.34%
1/290
|
0.00%
0/299
|
0.00%
0/273
|
0.00%
0/152
|
0.00%
0/134
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/304
|
0.00%
0/309
|
0.00%
0/290
|
0.33%
1/299
|
0.00%
0/273
|
0.00%
0/152
|
0.00%
0/134
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/304
|
0.00%
0/309
|
0.00%
0/290
|
0.00%
0/299
|
0.00%
0/273
|
0.00%
0/152
|
0.00%
0/134
|
0.37%
1/267
|
0.00%
0/150
|
0.00%
0/133
|
|
Infections and infestations
Ear infection
|
0.00%
0/304
|
0.00%
0/309
|
0.34%
1/290
|
0.33%
1/299
|
0.00%
0/273
|
0.00%
0/152
|
0.00%
0/134
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
Respiratory, thoracic and mediastinal disorders
Foreign body aspiration
|
0.00%
0/304
|
0.00%
0/309
|
0.00%
0/290
|
0.33%
1/299
|
0.00%
0/273
|
0.00%
0/152
|
0.00%
0/134
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
Infections and infestations
Gastroenteritis
|
0.33%
1/304
|
0.32%
1/309
|
0.69%
2/290
|
0.33%
1/299
|
0.00%
0/273
|
0.00%
0/152
|
0.75%
1/134
|
0.75%
2/267
|
0.00%
0/150
|
0.00%
0/133
|
|
Infections and infestations
Gastroenteritis bacterial
|
0.00%
0/304
|
0.00%
0/309
|
0.00%
0/290
|
0.00%
0/299
|
0.37%
1/273
|
0.00%
0/152
|
0.00%
0/134
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/304
|
0.32%
1/309
|
0.00%
0/290
|
0.00%
0/299
|
0.00%
0/273
|
0.00%
0/152
|
0.00%
0/134
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.00%
0/304
|
0.00%
0/309
|
0.34%
1/290
|
0.00%
0/299
|
0.00%
0/273
|
0.00%
0/152
|
0.00%
0/134
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
Injury, poisoning and procedural complications
Head injury
|
0.33%
1/304
|
0.00%
0/309
|
0.34%
1/290
|
0.00%
0/299
|
0.00%
0/273
|
0.00%
0/152
|
0.00%
0/134
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
Nervous system disorders
Hypotonia
|
0.00%
0/304
|
0.00%
0/309
|
0.00%
0/290
|
0.00%
0/299
|
0.37%
1/273
|
0.00%
0/152
|
0.00%
0/134
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/304
|
0.00%
0/309
|
0.00%
0/290
|
0.33%
1/299
|
0.00%
0/273
|
0.00%
0/152
|
0.00%
0/134
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/304
|
0.00%
0/309
|
0.00%
0/290
|
0.00%
0/299
|
0.00%
0/273
|
0.00%
0/152
|
0.75%
1/134
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
Infections and infestations
Meningitis
|
0.00%
0/304
|
0.32%
1/309
|
0.00%
0/290
|
0.00%
0/299
|
0.00%
0/273
|
0.00%
0/152
|
0.00%
0/134
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/304
|
0.00%
0/309
|
0.34%
1/290
|
0.00%
0/299
|
0.00%
0/273
|
0.00%
0/152
|
0.00%
0/134
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/304
|
0.00%
0/309
|
0.00%
0/290
|
0.00%
0/299
|
0.00%
0/273
|
0.00%
0/152
|
0.00%
0/134
|
0.37%
1/267
|
0.00%
0/150
|
0.00%
0/133
|
|
Infections and infestations
Pneumonia
|
0.00%
0/304
|
0.00%
0/309
|
0.00%
0/290
|
0.00%
0/299
|
0.00%
0/273
|
0.00%
0/152
|
0.00%
0/134
|
0.37%
1/267
|
0.00%
0/150
|
0.00%
0/133
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/304
|
0.32%
1/309
|
0.00%
0/290
|
0.33%
1/299
|
0.00%
0/273
|
0.00%
0/152
|
0.00%
0/134
|
0.37%
1/267
|
0.00%
0/150
|
0.00%
0/133
|
|
General disorders
Pyrexia
|
0.00%
0/304
|
0.32%
1/309
|
0.00%
0/290
|
0.00%
0/299
|
0.37%
1/273
|
0.00%
0/152
|
0.00%
0/134
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
Infections and infestations
Respiratory syncytial virus bronchiolitis
|
0.00%
0/304
|
0.00%
0/309
|
0.34%
1/290
|
0.00%
0/299
|
0.00%
0/273
|
0.00%
0/152
|
0.00%
0/134
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
Infections and infestations
Urinary tract infection
|
0.33%
1/304
|
0.00%
0/309
|
0.00%
0/290
|
0.00%
0/299
|
0.00%
0/273
|
0.00%
0/152
|
0.00%
0/134
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
Other adverse events
| Measure |
13vPnC Infant Series
n=304 participants at risk
Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series). Adverse events were collected from dose 1 to approximately one month after dose 3.
|
7vPnC Infant Series
n=309 participants at risk
Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series). Adverse events were collected from dose 1 to approximately one month after dose 3.
|
13vPnC Post-Infant Series
n=290 participants at risk
Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series). Adverse events were collected from approximately one month after dose 3 to toddler dose.
|
7vPnC Post-Infant Series
n=299 participants at risk
Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series). Adverse events were collected from approximately one month after dose 3 to toddler dose.
|
13vPnC/13vPnC Toddler Dose
n=272 participants at risk；n=273 participants at risk
Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose). Adverse events were collected for approximately one month after toddler dose.
|
7vPnC/7vPnC Toddler Dose
n=152 participants at risk
Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose). Adverse events were collected for approximately one month after toddler dose.
|
7vPnC/ 13vPnC Toddler Dose
n=137 participants at risk；n=134 participants at risk
Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose). Adverse events were collected for approximately one month after toddler dose.
|
13vPnC / 13vPnC 6-Month Follow-up
n=267 participants at risk
Participants received one single 0.5 mL dose of 13vPnC coadministered with Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler). Adverse events were collected for approximately six months after last visit.
|
7vPnC / 7vPnC 6-Month Follow-up
n=150 participants at risk
Participants received one single 0.5 mL dose of 7vPnC coadministered with Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler). Adverse events were collected for approximately six months after last visit.
|
7vPnC / 13vPnC 6-Month Follow-up
n=133 participants at risk
Participants received one single 0.5 mL dose of 7vPnC coadministered with Pentavac at 2, 3, and 4 months of age (infant series) and at 12 months of age (toddler). Adverse events were collected for approximately six months after last visit.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Erythema (Any)
|
55.8%
126/226
|
59.2%
132/223
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/304
|
0.00%
0/309
|
0.00%
0/290
|
0.33%
1/299
|
0.00%
0/272
|
0.00%
0/152
|
0.00%
0/137
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.00%
0/304
|
0.00%
0/309
|
0.34%
1/290
|
0.00%
0/299
|
0.00%
0/272
|
0.00%
0/152
|
0.00%
0/137
|
0.00%
0/267
|
0.00%
0/150
|
0.75%
1/133
|
|
Congenital, familial and genetic disorders
Dacryostenosis congenital
|
0.00%
0/304
|
0.32%
1/309
|
0.00%
0/290
|
0.00%
0/299
|
0.00%
0/272
|
0.00%
0/152
|
0.00%
0/137
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/304
|
0.00%
0/309
|
0.00%
0/290
|
0.00%
0/299
|
0.00%
0/272
|
0.66%
1/152
|
0.00%
0/137
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
Eye disorders
Conjunctivitis
|
2.0%
6/304
|
4.2%
13/309
|
0.00%
0/290
|
0.00%
0/299
|
1.1%
3/272
|
0.66%
1/152
|
2.2%
3/137
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
Eye disorders
Hypermetropia
|
0.00%
0/304
|
0.00%
0/309
|
0.00%
0/290
|
0.33%
1/299
|
0.00%
0/272
|
0.00%
0/152
|
0.00%
0/137
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
Gastrointestinal disorders
Diarrhoea
|
2.0%
6/304
|
0.97%
3/309
|
0.34%
1/290
|
0.33%
1/299
|
1.1%
3/272
|
0.66%
1/152
|
0.73%
1/137
|
0.37%
1/267
|
0.00%
0/150
|
0.00%
0/133
|
|
Gastrointestinal disorders
Vomiting
|
2.3%
7/304
|
0.65%
2/309
|
0.00%
0/290
|
0.33%
1/299
|
0.37%
1/272
|
0.66%
1/152
|
1.5%
2/137
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
Gastrointestinal disorders
Regurgitation
|
0.33%
1/304
|
1.3%
4/309
|
0.00%
0/290
|
0.00%
0/299
|
0.00%
0/272
|
0.00%
0/152
|
0.00%
0/137
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.66%
2/304
|
0.65%
2/309
|
0.00%
0/290
|
0.00%
0/299
|
0.00%
0/272
|
0.00%
0/152
|
0.00%
0/137
|
0.00%
0/267
|
0.67%
1/150
|
0.00%
0/133
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/304
|
0.65%
2/309
|
0.00%
0/290
|
0.00%
0/299
|
0.00%
0/272
|
0.00%
0/152
|
0.00%
0/137
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
Gastrointestinal disorders
Dental discomfort
|
0.00%
0/304
|
0.65%
2/309
|
0.00%
0/290
|
0.00%
0/299
|
0.00%
0/272
|
0.00%
0/152
|
0.00%
0/137
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
Gastrointestinal disorders
Infantile colic
|
0.33%
1/304
|
0.32%
1/309
|
0.00%
0/290
|
0.00%
0/299
|
0.00%
0/272
|
0.00%
0/152
|
0.00%
0/137
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/304
|
0.32%
1/309
|
0.00%
0/290
|
0.00%
0/299
|
0.00%
0/272
|
0.66%
1/152
|
0.00%
0/137
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/304
|
0.32%
1/309
|
0.00%
0/290
|
0.00%
0/299
|
0.00%
0/272
|
0.00%
0/152
|
0.00%
0/137
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/304
|
0.32%
1/309
|
0.00%
0/290
|
0.00%
0/299
|
0.00%
0/272
|
0.00%
0/152
|
0.00%
0/137
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.33%
1/304
|
0.00%
0/309
|
0.00%
0/290
|
0.00%
0/299
|
0.00%
0/272
|
0.00%
0/152
|
0.00%
0/137
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
Gastrointestinal disorders
Gastrointestinal inflammation
|
0.33%
1/304
|
0.00%
0/309
|
0.00%
0/290
|
0.00%
0/299
|
0.00%
0/272
|
0.00%
0/152
|
0.00%
0/137
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/304
|
0.32%
1/309
|
0.00%
0/290
|
0.00%
0/299
|
0.00%
0/272
|
0.00%
0/152
|
0.00%
0/137
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/304
|
0.32%
1/309
|
0.00%
0/290
|
0.00%
0/299
|
0.00%
0/272
|
0.00%
0/152
|
0.00%
0/137
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
General disorders
Injection site erythema
|
5.6%
17/304
|
5.2%
16/309
|
0.00%
0/290
|
0.00%
0/299
|
1.1%
3/272
|
2.0%
3/152
|
0.73%
1/137
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
General disorders
Pyrexia
|
3.3%
10/304
|
4.2%
13/309
|
0.00%
0/290
|
0.33%
1/299
|
1.8%
5/272
|
4.6%
7/152
|
2.9%
4/137
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
General disorders
Chills
|
0.33%
1/304
|
0.00%
0/309
|
0.00%
0/290
|
0.00%
0/299
|
0.00%
0/272
|
0.00%
0/152
|
0.00%
0/137
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
General disorders
Hyperthermia
|
0.33%
1/304
|
0.00%
0/309
|
0.00%
0/290
|
0.00%
0/299
|
0.00%
0/272
|
0.00%
0/152
|
0.00%
0/137
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
General disorders
Injection site induration
|
0.00%
0/304
|
0.32%
1/309
|
0.00%
0/290
|
0.00%
0/299
|
0.00%
0/272
|
0.00%
0/152
|
0.00%
0/137
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
General disorders
Injection site pain
|
0.33%
1/304
|
0.00%
0/309
|
0.00%
0/290
|
0.00%
0/299
|
0.00%
0/272
|
0.00%
0/152
|
0.00%
0/137
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
General disorders
Injection site reaction
|
0.00%
0/304
|
0.32%
1/309
|
0.00%
0/290
|
0.00%
0/299
|
0.00%
0/272
|
0.00%
0/152
|
0.00%
0/137
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
General disorders
Injection site swelling
|
0.00%
0/304
|
0.32%
1/309
|
0.00%
0/290
|
0.00%
0/299
|
0.00%
0/272
|
0.00%
0/152
|
0.00%
0/137
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
Immune system disorders
Milk allergy
|
0.33%
1/304
|
0.32%
1/309
|
0.00%
0/290
|
0.33%
1/299
|
0.00%
0/272
|
0.00%
0/152
|
0.00%
0/137
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
Infections and infestations
Rhinitis
|
8.2%
25/304
|
12.6%
39/309
|
0.00%
0/290
|
0.67%
2/299
|
2.9%
8/272
|
2.0%
3/152
|
1.5%
2/137
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
Infections and infestations
Nasopharyngitis
|
7.6%
23/304
|
10.4%
32/309
|
0.00%
0/290
|
0.00%
0/299
|
1.8%
5/272
|
2.6%
4/152
|
6.6%
9/137
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
Infections and infestations
Gastroenteritis
|
2.6%
8/304
|
6.1%
19/309
|
0.69%
2/290
|
0.00%
0/299
|
3.7%
10/272
|
3.3%
5/152
|
2.9%
4/137
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
Infections and infestations
Bronchiolitis
|
4.6%
14/304
|
1.6%
5/309
|
0.00%
0/290
|
0.00%
0/299
|
0.37%
1/272
|
2.0%
3/152
|
0.73%
1/137
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
Infections and infestations
Bronchitis
|
2.0%
6/304
|
3.9%
12/309
|
0.69%
2/290
|
0.00%
0/299
|
2.9%
8/272
|
3.9%
6/152
|
2.9%
4/137
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
Infections and infestations
Ear infection
|
1.6%
5/304
|
2.6%
8/309
|
0.34%
1/290
|
0.00%
0/299
|
5.9%
16/272
|
3.9%
6/152
|
3.6%
5/137
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
Infections and infestations
Tracheitis
|
0.99%
3/304
|
2.9%
9/309
|
0.00%
0/290
|
0.00%
0/299
|
2.6%
7/272
|
0.00%
0/152
|
1.5%
2/137
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
Infections and infestations
Varicella
|
1.6%
5/304
|
1.9%
6/309
|
0.00%
0/290
|
0.00%
0/299
|
1.1%
3/272
|
1.3%
2/152
|
0.00%
0/137
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
Infections and infestations
Pharyngitis
|
1.3%
4/304
|
1.6%
5/309
|
0.00%
0/290
|
0.00%
0/299
|
0.74%
2/272
|
1.3%
2/152
|
0.00%
0/137
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
Infections and infestations
Bronchitis viral
|
0.66%
2/304
|
0.97%
3/309
|
0.00%
0/290
|
0.00%
0/299
|
0.00%
0/272
|
0.00%
0/152
|
0.00%
0/137
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
Infections and infestations
Fungal skin infection
|
0.99%
3/304
|
0.65%
2/309
|
0.00%
0/290
|
0.00%
0/299
|
0.00%
0/272
|
0.00%
0/152
|
0.00%
0/137
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
Infections and infestations
Rhinotracheitis
|
0.66%
2/304
|
0.97%
3/309
|
0.00%
0/290
|
0.00%
0/299
|
0.00%
0/272
|
0.00%
0/152
|
0.00%
0/137
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
Infections and infestations
Roseola
|
0.33%
1/304
|
0.97%
3/309
|
0.00%
0/290
|
0.00%
0/299
|
0.00%
0/272
|
0.00%
0/152
|
0.73%
1/137
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
Infections and infestations
Viral infection
|
0.66%
2/304
|
0.65%
2/309
|
0.00%
0/290
|
0.33%
1/299
|
0.00%
0/272
|
0.66%
1/152
|
0.00%
0/137
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
Infections and infestations
Fungal infection
|
0.99%
3/304
|
0.00%
0/309
|
0.00%
0/290
|
0.00%
0/299
|
0.00%
0/272
|
0.00%
0/152
|
0.00%
0/137
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
Infections and infestations
Laryngitis
|
0.33%
1/304
|
0.65%
2/309
|
0.00%
0/290
|
0.00%
0/299
|
0.74%
2/272
|
0.00%
0/152
|
1.5%
2/137
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
Infections and infestations
Oral candidiasis
|
0.99%
3/304
|
0.00%
0/309
|
0.00%
0/290
|
0.00%
0/299
|
0.00%
0/272
|
0.00%
0/152
|
0.00%
0/137
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
Infections and infestations
Candidiasis
|
0.33%
1/304
|
0.32%
1/309
|
0.00%
0/290
|
0.00%
0/299
|
0.00%
0/272
|
0.00%
0/152
|
0.00%
0/137
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
Infections and infestations
Rhinolaryngitis
|
0.33%
1/304
|
0.32%
1/309
|
0.00%
0/290
|
0.00%
0/299
|
0.37%
1/272
|
0.00%
0/152
|
0.00%
0/137
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/304
|
0.65%
2/309
|
0.00%
0/290
|
0.00%
0/299
|
0.00%
0/272
|
0.00%
0/152
|
0.73%
1/137
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
Infections and infestations
Viral skin infection
|
0.33%
1/304
|
0.32%
1/309
|
0.00%
0/290
|
0.00%
0/299
|
0.37%
1/272
|
0.00%
0/152
|
0.73%
1/137
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
Infections and infestations
Dacryocystitis
|
0.00%
0/304
|
0.32%
1/309
|
0.00%
0/290
|
0.00%
0/299
|
0.00%
0/272
|
0.00%
0/152
|
0.00%
0/137
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
Infections and infestations
Erythema infectiosum
|
0.33%
1/304
|
0.00%
0/309
|
0.00%
0/290
|
0.00%
0/299
|
0.00%
0/272
|
0.00%
0/152
|
0.00%
0/137
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
Infections and infestations
Furuncle
|
0.33%
1/304
|
0.00%
0/309
|
0.00%
0/290
|
0.00%
0/299
|
0.00%
0/272
|
0.00%
0/152
|
0.00%
0/137
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
Infections and infestations
Influenza
|
0.00%
0/304
|
0.32%
1/309
|
0.00%
0/290
|
0.00%
0/299
|
0.37%
1/272
|
0.00%
0/152
|
0.00%
0/137
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
Infections and infestations
Otitis media
|
0.33%
1/304
|
0.00%
0/309
|
0.00%
0/290
|
0.00%
0/299
|
1.1%
3/272
|
0.66%
1/152
|
0.73%
1/137
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/304
|
0.32%
1/309
|
0.00%
0/290
|
0.00%
0/299
|
0.00%
0/272
|
0.00%
0/152
|
0.73%
1/137
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
Infections and infestations
Tracheobronchitis
|
0.00%
0/304
|
0.32%
1/309
|
0.00%
0/290
|
0.00%
0/299
|
0.37%
1/272
|
0.66%
1/152
|
0.00%
0/137
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
Infections and infestations
Otitis media chronic
|
0.00%
0/304
|
0.00%
0/309
|
0.34%
1/290
|
0.00%
0/299
|
0.00%
0/272
|
0.00%
0/152
|
0.00%
0/137
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
Infections and infestations
Exanthema subitum
|
0.00%
0/304
|
0.00%
0/309
|
0.00%
0/290
|
0.00%
0/299
|
0.37%
1/272
|
0.00%
0/152
|
0.00%
0/137
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
Infections and infestations
Genital candidiasis
|
0.00%
0/304
|
0.00%
0/309
|
0.00%
0/290
|
0.00%
0/299
|
0.37%
1/272
|
0.00%
0/152
|
0.00%
0/137
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
Infections and infestations
Human herpesvirus 6 infection
|
0.00%
0/304
|
0.00%
0/309
|
0.00%
0/290
|
0.00%
0/299
|
0.00%
0/272
|
0.66%
1/152
|
0.00%
0/137
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
Infections and infestations
Oral herpes
|
0.00%
0/304
|
0.00%
0/309
|
0.00%
0/290
|
0.00%
0/299
|
0.00%
0/272
|
0.00%
0/152
|
0.73%
1/137
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/304
|
0.00%
0/309
|
0.00%
0/290
|
0.00%
0/299
|
0.00%
0/272
|
0.00%
0/152
|
0.73%
1/137
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/304
|
0.00%
0/309
|
0.00%
0/290
|
0.00%
0/299
|
0.37%
1/272
|
0.00%
0/152
|
0.00%
0/137
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
Infections and infestations
Infectious mononucleosis
|
0.00%
0/304
|
0.00%
0/309
|
0.00%
0/290
|
0.00%
0/299
|
0.00%
0/272
|
0.00%
0/152
|
0.00%
0/137
|
0.00%
0/267
|
0.67%
1/150
|
0.00%
0/133
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.33%
1/304
|
0.00%
0/309
|
0.00%
0/290
|
0.00%
0/299
|
0.00%
0/272
|
0.00%
0/152
|
0.00%
0/137
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/304
|
0.00%
0/309
|
0.00%
0/290
|
0.00%
0/299
|
0.37%
1/272
|
0.00%
0/152
|
0.00%
0/137
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
Investigations
Bacteria stool identified
|
0.00%
0/304
|
0.32%
1/309
|
0.00%
0/290
|
0.00%
0/299
|
0.00%
0/272
|
0.00%
0/152
|
0.00%
0/137
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.33%
1/304
|
0.32%
1/309
|
0.00%
0/290
|
0.00%
0/299
|
0.00%
0/272
|
0.00%
0/152
|
0.00%
0/137
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/304
|
0.00%
0/309
|
0.00%
0/290
|
0.00%
0/299
|
0.37%
1/272
|
0.00%
0/152
|
0.00%
0/137
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
Nervous system disorders
Facial palsy
|
0.00%
0/304
|
0.00%
0/309
|
0.00%
0/290
|
0.00%
0/299
|
0.00%
0/272
|
0.00%
0/152
|
0.00%
0/137
|
0.00%
0/267
|
0.67%
1/150
|
0.00%
0/133
|
|
Psychiatric disorders
Crying
|
0.00%
0/304
|
0.65%
2/309
|
0.00%
0/290
|
0.00%
0/299
|
0.00%
0/272
|
0.00%
0/152
|
0.00%
0/137
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
Psychiatric disorders
Agitation
|
0.00%
0/304
|
0.32%
1/309
|
0.00%
0/290
|
0.00%
0/299
|
0.00%
0/272
|
0.00%
0/152
|
0.00%
0/137
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.3%
4/304
|
1.9%
6/309
|
0.00%
0/290
|
0.33%
1/299
|
0.37%
1/272
|
1.3%
2/152
|
0.73%
1/137
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.99%
3/304
|
0.32%
1/309
|
0.00%
0/290
|
0.00%
0/299
|
0.00%
0/272
|
0.00%
0/152
|
0.00%
0/137
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
Respiratory, thoracic and mediastinal disorders
Allergic respiratory disease
|
0.00%
0/304
|
0.65%
2/309
|
0.00%
0/290
|
0.00%
0/299
|
0.00%
0/272
|
0.00%
0/152
|
0.00%
0/137
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.33%
1/304
|
0.32%
1/309
|
1.0%
3/290
|
1.0%
3/299
|
0.37%
1/272
|
0.66%
1/152
|
0.73%
1/137
|
0.37%
1/267
|
0.00%
0/150
|
0.00%
0/133
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/304
|
0.32%
1/309
|
0.00%
0/290
|
0.00%
0/299
|
0.37%
1/272
|
0.00%
0/152
|
0.00%
0/137
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.00%
0/304
|
0.00%
0/309
|
0.00%
0/290
|
0.33%
1/299
|
0.00%
0/272
|
0.00%
0/152
|
0.00%
0/137
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
Skin and subcutaneous tissue disorders
Eczema
|
4.3%
13/304
|
2.6%
8/309
|
0.34%
1/290
|
0.00%
0/299
|
0.37%
1/272
|
0.66%
1/152
|
0.73%
1/137
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.33%
1/304
|
0.65%
2/309
|
0.00%
0/290
|
0.00%
0/299
|
0.00%
0/272
|
0.00%
0/152
|
0.00%
0/137
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/304
|
0.97%
3/309
|
0.00%
0/290
|
0.00%
0/299
|
0.00%
0/272
|
0.66%
1/152
|
0.73%
1/137
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.33%
1/304
|
0.65%
2/309
|
0.00%
0/290
|
0.00%
0/299
|
1.5%
4/272
|
0.00%
0/152
|
0.73%
1/137
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.33%
1/304
|
0.32%
1/309
|
0.00%
0/290
|
0.00%
0/299
|
1.1%
3/272
|
0.00%
0/152
|
0.00%
0/137
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/304
|
0.32%
1/309
|
0.00%
0/290
|
0.00%
0/299
|
0.00%
0/272
|
0.00%
0/152
|
0.00%
0/137
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
Skin and subcutaneous tissue disorders
Heat rash
|
0.33%
1/304
|
0.00%
0/309
|
0.00%
0/290
|
0.00%
0/299
|
0.00%
0/272
|
0.00%
0/152
|
0.00%
0/137
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
Skin and subcutaneous tissue disorders
Nail bed inflammation
|
0.33%
1/304
|
0.00%
0/309
|
0.00%
0/290
|
0.00%
0/299
|
0.00%
0/272
|
0.00%
0/152
|
0.00%
0/137
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/304
|
0.32%
1/309
|
0.00%
0/290
|
0.00%
0/299
|
0.00%
0/272
|
0.00%
0/152
|
0.00%
0/137
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
Skin and subcutaneous tissue disorders
Rash morbilliform
|
0.33%
1/304
|
0.00%
0/309
|
0.00%
0/290
|
0.00%
0/299
|
0.00%
0/272
|
0.00%
0/152
|
0.00%
0/137
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
Skin and subcutaneous tissue disorders
Eczema asteatotic
|
0.00%
0/304
|
0.00%
0/309
|
0.00%
0/290
|
0.00%
0/299
|
0.00%
0/272
|
0.00%
0/152
|
0.00%
0/137
|
0.00%
0/267
|
0.00%
0/150
|
0.75%
1/133
|
|
Social circumstances
Child abuse
|
0.00%
0/304
|
0.32%
1/309
|
0.00%
0/290
|
0.00%
0/299
|
0.00%
0/272
|
0.00%
0/152
|
0.00%
0/137
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
Vascular disorders
Haematoma
|
0.33%
1/304
|
0.00%
0/309
|
0.00%
0/290
|
0.00%
0/299
|
0.00%
0/272
|
0.00%
0/152
|
0.00%
0/137
|
0.00%
0/267
|
0.00%
0/150
|
0.00%
0/133
|
|
Skin and subcutaneous tissue disorders
Tenderness (Any)
|
36.2%
76/210
|
32.0%
66/206
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
Skin and subcutaneous tissue disorders
Tenderness (Significant)
|
3.7%
7/188
|
3.1%
6/193
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
Skin and subcutaneous tissue disorders
Induration (Any)
|
48.4%
105/217
|
51.1%
112/219
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
Skin and subcutaneous tissue disorders
Induration (Mild)
|
44.6%
95/213
|
45.8%
98/214
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
Skin and subcutaneous tissue disorders
Induration (Moderate)
|
14.0%
27/193
|
16.0%
31/194
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
Skin and subcutaneous tissue disorders
Induration (Severe)
|
0.00%
0/184
|
0.00%
0/188
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
Skin and subcutaneous tissue disorders
Erythema (Mild)
|
52.5%
117/223
|
55.7%
123/221
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
Skin and subcutaneous tissue disorders
Erythema (Moderate)
|
8.9%
17/190
|
12.5%
24/192
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
Skin and subcutaneous tissue disorders
Erythema (Severe)
|
0.00%
0/184
|
0.00%
0/188
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
General disorders
Fever ≥38°C but ≤39°C
|
26.9%
54/201
|
27.9%
58/208
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
General disorders
Fever >39°C but ≤40°C
|
0.54%
1/184
|
1.6%
3/191
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
General disorders
Fever >40°C
|
0.54%
1/184
|
0.00%
0/190
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
General disorders
Decreased appetite
|
23.2%
45/194
|
21.1%
42/199
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
General disorders
Irritability
|
41.9%
91/217
|
40.3%
85/211
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
General disorders
Increased sleep
|
23.7%
46/194
|
28.4%
58/204
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
General disorders
Decreased sleep
|
25.1%
51/203
|
20.9%
41/196
|
—
0/0
|
—
0/0
|
—
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