Trial Outcomes & Findings for Study Evaluating a 13-Valent Pneumococcal Conjugate Vaccine in Healthy Infants (NCT NCT00474539)
NCT ID: NCT00474539
Last Updated: 2013-03-05
Results Overview
Percentage of participants achieving a meningococcal C SBA serum antibody titer greater than or equal to (≥) 1:8 along with the corresponding 95% confidence interval (CI) are presented.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
449 participants
Primary outcome timeframe
One month after infant series dose (at 5 months of age)
Results posted on
2013-03-05
Participant Flow
Participants were recruited in Spain from 4 July 2007 to 23 July 2007.
Participants were enrolled into the study according to the inclusion/exclusion criteria without a screening period.
Participant milestones
| Measure |
13vPnC
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and combined diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) at the 2- and 4-month visits (infant series Dose 2) and one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3). Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and combined DTPa, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix IPV + Hib) at the 15-month visit (toddler dose). Measles, mumps, and rubella vaccine (MMR) was administered without study vaccine at the 12-month visit.
|
7vPnC
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and combined diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) at the 2- and 4-month visits (infant series Dose 2) and one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3). Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and combined DTPa, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix IPV + Hib) at the 15-month visit (toddler dose). Measles, mumps, and rubella vaccine (MMR) was administered without study vaccine at the 12-month visit.
|
|---|---|---|
|
Infant Series
STARTED
|
223
|
226
|
|
Infant Series
Vaccinated Dose 1
|
218
|
226
|
|
Infant Series
Vaccinated Dose 2
|
217
|
222
|
|
Infant Series
Vaccinated Dose 3
|
214
|
221
|
|
Infant Series
COMPLETED
|
213
|
220
|
|
Infant Series
NOT COMPLETED
|
10
|
6
|
|
After Infant Series
STARTED
|
213
|
220
|
|
After Infant Series
COMPLETED
|
209
|
220
|
|
After Infant Series
NOT COMPLETED
|
4
|
0
|
|
Toddler Dose
STARTED
|
209
|
220
|
|
Toddler Dose
COMPLETED
|
208
|
220
|
|
Toddler Dose
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
13vPnC
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and combined diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) at the 2- and 4-month visits (infant series Dose 2) and one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3). Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and combined DTPa, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix IPV + Hib) at the 15-month visit (toddler dose). Measles, mumps, and rubella vaccine (MMR) was administered without study vaccine at the 12-month visit.
|
7vPnC
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and combined diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) at the 2- and 4-month visits (infant series Dose 2) and one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3). Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and combined DTPa, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix IPV + Hib) at the 15-month visit (toddler dose). Measles, mumps, and rubella vaccine (MMR) was administered without study vaccine at the 12-month visit.
|
|---|---|---|
|
Infant Series
Withdrawal by Subject
|
3
|
4
|
|
Infant Series
Randomization error
|
5
|
0
|
|
Infant Series
Lost to Follow-up
|
2
|
1
|
|
Infant Series
Protocol Violation
|
0
|
1
|
|
After Infant Series
Lost to Follow-up
|
3
|
0
|
|
After Infant Series
Withdrawal by Subject
|
1
|
0
|
|
Toddler Dose
Protocol Violation
|
1
|
0
|
Baseline Characteristics
Study Evaluating a 13-Valent Pneumococcal Conjugate Vaccine in Healthy Infants
Baseline characteristics by cohort
| Measure |
13vPnC
n=219 Participants
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and combined diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) at the 2- and 4-month visits (infant series Dose 2) and one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3). Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and combined DTPa, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix IPV + Hib) at the 15-month visit (toddler dose). Measles, mumps, and rubella vaccine (MMR) was administered without study vaccine at the 12-month visit.
|
7vPnC
n=225 Participants
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and combined diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) at the 2- and 4-month visits (infant series Dose 2) and one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3). Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and combined DTPa, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix IPV + Hib) at the 15-month visit (toddler dose). Measles, mumps, and rubella vaccine (MMR) was administered without study vaccine at the 12-month visit.
|
Total
n=444 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
2.1 months
STANDARD_DEVIATION 0.4 • n=5 Participants
|
2.0 months
STANDARD_DEVIATION 0.4 • n=7 Participants
|
2.1 months
STANDARD_DEVIATION 0.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
104 Participants
n=5 Participants
|
116 Participants
n=7 Participants
|
220 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
115 Participants
n=5 Participants
|
109 Participants
n=7 Participants
|
224 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: One month after infant series dose (at 5 months of age)Population: Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n)= number of participants with a determinate immunoglobulin G (IgG) antibody concentration to the given concomitant vaccine component.
Percentage of participants achieving a meningococcal C SBA serum antibody titer greater than or equal to (≥) 1:8 along with the corresponding 95% confidence interval (CI) are presented.
Outcome measures
| Measure |
13vPnC After Infant Series Dose 2
n=206 Participants
Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits (infant series Dose 2).
|
7vPnC After Infant Series Dose 2
n=218 Participants
Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits (infant series Dose 2).
|
13vPnC Dose 2
Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at the 4-month visit.
|
7vPnC Dose 2
Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix hexa at the 4-month visit.
|
13vPnC Dose 3
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa and at the 6-month visit.
|
7vPnC Dose 3
Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa and at the 6-month visit.
|
13vPnC Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix-IPV+Hib at the 15-month visit.
|
7vPnC Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with with NeisVac-C and Infanrix-IPV+Hib at the 15-month visit.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving a Serum Bactericidal Assay (SBA) Titer ≥ 1:8 in 13vPnC Group Relative to 7vPnC Group After the 2-dose NeisVac-C Infant Series
|
98.5 percentage of participants
Interval 95.8 to 99.7
|
99.1 percentage of participants
Interval 96.7 to 99.9
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: One month after infant series dose 2 (at 5 months of age) and one month after toddler dose (at 16 months of age)Population: The evaluable 2-dose 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 Infant Series Dose 2
n=206 Participants
Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits (infant series Dose 2).
|
7vPnC After Infant Series Dose 2
n=218 Participants
Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits (infant series Dose 2).
|
13vPnC Dose 2
n=164 Participants
Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at the 4-month visit.
|
7vPnC Dose 2
n=172 Participants
Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix hexa at the 4-month visit.
|
13vPnC Dose 3
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa and at the 6-month visit.
|
7vPnC Dose 3
Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa and at the 6-month visit.
|
13vPnC Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix-IPV+Hib at the 15-month visit.
|
7vPnC Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with with NeisVac-C and Infanrix-IPV+Hib at the 15-month visit.
|
|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Titers (GMT) for Meningococcal C Antibodies in as Measured by Serum Bactericidal Assay (SBA) 13vPnC Group Relative to 7vPnC Group After the 2-dose NeisVac-C Infant Series and the Toddler Dose
|
654.55 titer
Interval 557.75 to 768.16
|
757.04 titer
Interval 648.45 to 883.81
|
2573.06 titer
Interval 2176.29 to 3042.16
|
2098.12 titer
Interval 1779.65 to 2473.58
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: One month after infant series dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)Population: The evaluable 3-dose 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.
Predefined antibody levels for Diphtheria (0.01 or 0.1 International units \[IU\]/mL) and Tetanus (0.01 or 0.1 \[IU\]/mL).
Outcome measures
| Measure |
13vPnC After Infant Series Dose 2
n=197 Participants
Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits (infant series Dose 2).
|
7vPnC After Infant Series Dose 2
n=212 Participants
Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits (infant series Dose 2).
|
13vPnC Dose 2
n=164 Participants
Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at the 4-month visit.
|
7vPnC Dose 2
n=172 Participants
Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix hexa at the 4-month visit.
|
13vPnC Dose 3
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa and at the 6-month visit.
|
7vPnC Dose 3
Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa and at the 6-month visit.
|
13vPnC Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix-IPV+Hib at the 15-month visit.
|
7vPnC Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with with NeisVac-C and Infanrix-IPV+Hib at the 15-month visit.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and After the Toddler Dose
Diphtheria ≥0.10 IU/mL
|
98.5 percentage of participants
Interval 95.6 to 99.7
|
99.1 percentage of participants
Interval 96.6 to 99.9
|
100.0 percentage of participants
Interval 97.8 to 100.0
|
100.0 percentage of participants
Interval 97.9 to 100.0
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and After the Toddler Dose
Diphtheria ≥0.01 IU/mL
|
100.0 percentage of participants
Interval 98.1 to 100.0
|
100.0 percentage of participants
Interval 98.3 to 100.0
|
100.0 percentage of participants
Interval 97.8 to 100.0
|
100.0 percentage of participants
Interval 97.9 to 100.0
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and After the Toddler Dose
Tetanus ≥0.10 IU/mL
|
96.6 percentage of participants
Interval 92.6 to 98.7
|
96.7 percentage of participants
Interval 93.0 to 98.8
|
100.0 percentage of participants
Interval 97.8 to 100.0
|
100.0 percentage of participants
Interval 97.9 to 100.0
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and After the Toddler Dose
Tetanus ≥0.01 IU/mL
|
100.0 percentage of participants
Interval 97.9 to 100.0
|
100.0 percentage of participants
Interval 98.0 to 100.0
|
100.0 percentage of participants
Interval 97.8 to 100.0
|
100.0 percentage of participants
Interval 97.9 to 100.0
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: One month after infant series dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)Population: The evaluable 3-dose 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 Infant Series Dose 2
n=197 Participants
Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits (infant series Dose 2).
|
7vPnC After Infant Series Dose 2
n=212 Participants
Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits (infant series Dose 2).
|
13vPnC Dose 2
n=164 Participants
Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at the 4-month visit.
|
7vPnC Dose 2
n=172 Participants
Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix hexa at the 4-month visit.
|
13vPnC Dose 3
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa and at the 6-month visit.
|
7vPnC Dose 3
Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa and at the 6-month visit.
|
13vPnC Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix-IPV+Hib at the 15-month visit.
|
7vPnC Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with with NeisVac-C and Infanrix-IPV+Hib at the 15-month visit.
|
|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Antibody Concentrations (GMC) for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and After the Toddler Dose
Tetanus
|
1.10 IU/mL
Interval 0.94 to 1.27
|
1.20 IU/mL
Interval 1.04 to 1.39
|
3.29 IU/mL
Interval 2.83 to 3.83
|
3.28 IU/mL
Interval 2.83 to 3.79
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentrations (GMC) for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and After the Toddler Dose
Diphtheria
|
0.79 IU/mL
Interval 0.69 to 0.9
|
0.92 IU/mL
Interval 0.81 to 1.04
|
3.00 IU/mL
Interval 2.63 to 3.41
|
3.23 IU/mL
Interval 2.88 to 3.63
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: One month after infant series dose 2 (at 5 months of age) and dose 3 (at 7 months of age) and one month after the toddler dose (at 16 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.
Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥ 0.35 μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
Outcome measures
| Measure |
13vPnC After Infant Series Dose 2
n=206 Participants
Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits (infant series Dose 2).
|
7vPnC After Infant Series Dose 2
n=197 Participants
Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits (infant series Dose 2).
|
13vPnC Dose 2
n=212 Participants
Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at the 4-month visit.
|
7vPnC Dose 2
Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix hexa at the 4-month visit.
|
13vPnC Dose 3
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa and at the 6-month visit.
|
7vPnC Dose 3
Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa and at the 6-month visit.
|
13vPnC Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix-IPV+Hib at the 15-month visit.
|
7vPnC Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with with NeisVac-C and Infanrix-IPV+Hib at the 15-month visit.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Antibody Level ≥ 0.35μg/mL in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose
Common Serotypes - Serotype 4
|
92.5 percentage of participants
Interval 87.9 to 95.7
|
98.5 percentage of participants
Interval 95.7 to 99.7
|
100.0 percentage of participants
Interval 97.7 to 100.0
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥ 0.35μg/mL in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose
Common Serotypes - Serotype 6B
|
27.9 percentage of participants
Interval 21.8 to 34.7
|
94.9 percentage of participants
Interval 90.9 to 97.5
|
100.0 percentage of participants
Interval 97.7 to 100.0
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥ 0.35μg/mL in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose
Common Serotypes - Serotype 9V
|
89.9 percentage of participants
Interval 84.8 to 93.7
|
97.0 percentage of participants
Interval 93.5 to 98.9
|
99.3 percentage of participants
Interval 96.3 to 100.0
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥ 0.35μg/mL in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose
Common Serotypes - Serotype 14
|
91.0 percentage of participants
Interval 86.1 to 94.6
|
97.0 percentage of participants
Interval 93.6 to 98.9
|
99.4 percentage of participants
Interval 96.6 to 100.0
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥ 0.35μg/mL in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose
Common Serotypes - Serotype 18C
|
88.9 percentage of participants
Interval 83.7 to 92.9
|
99.0 percentage of participants
Interval 96.4 to 99.9
|
98.8 percentage of participants
Interval 95.6 to 99.8
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥ 0.35μg/mL in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose
Common Serotypes - Serotype 19F
|
100.0 percentage of participants
Interval 98.2 to 100.0
|
99.0 percentage of participants
Interval 96.4 to 99.9
|
98.7 percentage of participants
Interval 95.5 to 99.8
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥ 0.35μg/mL in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose
Common Serotypes - Serotype 23F
|
55.8 percentage of participants
Interval 48.6 to 62.8
|
93.0 percentage of participants
Interval 88.5 to 96.1
|
98.1 percentage of participants
Interval 94.7 to 99.6
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥ 0.35μg/mL in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose
Additional Serotypes - Serotype 1
|
96.0 percentage of participants
Interval 92.2 to 98.2
|
98.5 percentage of participants
Interval 95.7 to 99.7
|
98.8 percentage of participants
Interval 95.6 to 99.8
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥ 0.35μg/mL in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose
Additional Serotypes - Serotype 3
|
73.8 percentage of participants
Interval 67.1 to 79.9
|
86.2 percentage of participants
Interval 80.5 to 90.7
|
93.6 percentage of participants
Interval 88.6 to 96.9
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥ 0.35μg/mL in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose
Additional Serotypes - Serotype 5
|
86.4 percentage of participants
Interval 80.8 to 90.8
|
96.0 percentage of participants
Interval 92.2 to 98.2
|
100.0 percentage of participants
Interval 97.6 to 100.0
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥ 0.35μg/mL in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose
Additional Serotypes - Serotype 6A
|
80.8 percentage of participants
Interval 74.6 to 86.0
|
99.0 percentage of participants
Interval 96.4 to 99.9
|
99.4 percentage of participants
Interval 96.5 to 100.0
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥ 0.35μg/mL in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose
Additional Serotypes - Serotype 7F
|
94.5 percentage of participants
Interval 90.3 to 97.2
|
100.0 percentage of participants
Interval 98.2 to 100.0
|
99.4 percentage of participants
Interval 96.5 to 100.0
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥ 0.35μg/mL in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose
Additional Serotypes - Serotype 19A
|
92.9 percentage of participants
Interval 88.4 to 96.1
|
99.5 percentage of participants
Interval 97.2 to 100.0
|
100.0 percentage of participants
Interval 97.5 to 100.0
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: One month after infant series dose 2 (at 5 months of age) and dose 3 (at 7 months of age) and one month after the toddler dose (at 16 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.
GMC as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMCs (13vPnC) were calculated for each pneumococcal serotype and timepoint, and 2-sided, 95% CI were constructed.
Outcome measures
| Measure |
13vPnC After Infant Series Dose 2
n=206 Participants
Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits (infant series Dose 2).
|
7vPnC After Infant Series Dose 2
n=197 Participants
Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits (infant series Dose 2).
|
13vPnC Dose 2
n=212 Participants
Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at the 4-month visit.
|
7vPnC Dose 2
Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix hexa at the 4-month visit.
|
13vPnC Dose 3
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa and at the 6-month visit.
|
7vPnC Dose 3
Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa and at the 6-month visit.
|
13vPnC Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix-IPV+Hib at the 15-month visit.
|
7vPnC Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with with NeisVac-C and Infanrix-IPV+Hib at the 15-month visit.
|
|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Antibody Concentration (GMC) in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose
Common Serotypes - Serotype 4
|
1.55 μg/mL
Interval 1.35 to 1.78
|
2.32 μg/mL
Interval 2.08 to 2.6
|
3.88 μg/mL
Interval 3.42 to 4.4
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration (GMC) in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose
Common Serotypes - Serotype 6B
|
0.21 μg/mL
Interval 0.18 to 0.25
|
2.59 μg/mL
Interval 2.2 to 3.05
|
12.25 μg/mL
Interval 10.78 to 13.92
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration (GMC) in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose
Common Serotypes - Serotype 9V
|
1.15 μg/mL
Interval 1.01 to 1.32
|
1.51 μg/mL
Interval 1.35 to 1.68
|
2.67 μg/mL
Interval 2.34 to 3.05
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration (GMC) in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose
Common Serotypes - Serotype 14
|
1.94 μg/mL
Interval 1.64 to 2.29
|
4.51 μg/mL
Interval 3.89 to 5.22
|
9.82 μg/mL
Interval 8.54 to 11.3
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration (GMC) in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose
Common Serotypes - Serotype 18C
|
1.30 μg/mL
Interval 1.11 to 1.51
|
1.86 μg/mL
Interval 1.68 to 2.07
|
2.29 μg/mL
Interval 2.01 to 2.61
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration (GMC) in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose
Common Serotypes - Serotype 19F
|
2.98 μg/mL
Interval 2.6 to 3.41
|
2.46 μg/mL
Interval 2.21 to 2.74
|
6.11 μg/mL
Interval 5.21 to 7.16
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration (GMC) in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose
Common Serotypes - Serotype 23F
|
0.40 μg/mL
Interval 0.34 to 0.48
|
1.67 μg/mL
Interval 1.44 to 1.94
|
3.96 μg/mL
Interval 3.43 to 4.59
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration (GMC) in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose
Additional Serotypes - Serotype 1
|
1.87 μg/mL
Interval 1.61 to 2.16
|
2.95 μg/mL
Interval 2.61 to 3.33
|
4.60 μg/mL
Interval 3.94 to 5.37
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration (GMC) in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose
Additional Serotypes - Serotype 3
|
0.54 μg/mL
Interval 0.48 to 0.61
|
0.85 μg/mL
Interval 0.76 to 0.95
|
1.04 μg/mL
Interval 0.91 to 1.19
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration (GMC) in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose
Additional Serotypes - Serotype 5
|
0.88 μg/mL
Interval 0.77 to 1.0
|
1.83 μg/mL
Interval 1.62 to 2.06
|
3.69 μg/mL
Interval 3.26 to 4.18
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration (GMC) in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose
Additional Serotypes - Serotype 6A
|
0.81 μg/mL
Interval 0.7 to 0.95
|
3.08 μg/mL
Interval 2.76 to 3.44
|
7.71 μg/mL
Interval 6.75 to 8.8
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration (GMC) in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose
Additional Serotypes - Serotype 7F
|
1.51 μg/mL
Interval 1.33 to 1.71
|
3.41 μg/mL
Interval 3.11 to 3.74
|
5.66 μg/mL
Interval 4.9 to 6.53
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration (GMC) in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose
Additional Serotypes - Serotype 19A
|
1.52 μg/mL
Interval 1.31 to 1.76
|
2.50 μg/mL
Interval 2.27 to 2.75
|
10.21 μg/mL
Interval 8.92 to 11.68
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: One month after toddler dose (at 16 months of age)Population: Evaluable immunogenicity (per protocol) population consisting of eligible participants 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 IgG antibody concentration to the given concomitant vaccine component.
Percentage of participants achieving a meningococcal C SBA serum antibody titer ≥ 1:8 along with the corresponding 95% confidence interval (CI) are presented.
Outcome measures
| Measure |
13vPnC After Infant Series Dose 2
n=164 Participants
Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits (infant series Dose 2).
|
7vPnC After Infant Series Dose 2
n=172 Participants
Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits (infant series Dose 2).
|
13vPnC Dose 2
Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at the 4-month visit.
|
7vPnC Dose 2
Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix hexa at the 4-month visit.
|
13vPnC Dose 3
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa and at the 6-month visit.
|
7vPnC Dose 3
Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa and at the 6-month visit.
|
13vPnC Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix-IPV+Hib at the 15-month visit.
|
7vPnC Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with with NeisVac-C and Infanrix-IPV+Hib at the 15-month visit.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving a Serum Bactericidal Assay (SBA) Titer ≥ 1:8 in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose
|
100.0 percentage of participants
Interval 97.8 to 100.0
|
99.4 percentage of participants
Interval 96.8 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED 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 was scaled as Any (tenderness present); Significant (Sig)(present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters \[cm\] to 2.0 cm); Moderate (Mod) (2.5 to 7.0 cm); Severe (Sev) (\>7.0 cm). Participants may be represented in more than 1 category.
Outcome measures
| Measure |
13vPnC After Infant Series Dose 2
n=218 Participants
Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits (infant series Dose 2).
|
7vPnC After Infant Series Dose 2
n=226 Participants
Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits (infant series Dose 2).
|
13vPnC Dose 2
n=217 Participants
Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at the 4-month visit.
|
7vPnC Dose 2
n=222 Participants
Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix hexa at the 4-month visit.
|
13vPnC Dose 3
n=214 Participants
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa and at the 6-month visit.
|
7vPnC Dose 3
n=221 Participants
Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa and at the 6-month visit.
|
13vPnC Toddler Dose
n=209 Participants
Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix-IPV+Hib at the 15-month visit.
|
7vPnC Toddler Dose
n=220 Participants
Participants received one single 0.5 mL dose of 7vPnC coadministered with with NeisVac-C and Infanrix-IPV+Hib at the 15-month visit.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Reporting Pre-Specified Local Reactions
Tenderness-Any (n=199,205,182,180,170,175,164,172)
|
21.1 percentage of participants
|
18.5 percentage of participants
|
21.4 percentage of participants
|
16.1 percentage of participants
|
10.6 percentage of participants
|
14.3 percentage of participants
|
28.7 percentage of participants
|
26.7 percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions
Tenderness-Sig (n=199,200,177,177,167,169,154,160)
|
3.0 percentage of participants
|
4.0 percentage of participants
|
1.1 percentage of participants
|
4.0 percentage of participants
|
1.2 percentage of participants
|
1.2 percentage of participants
|
2.6 percentage of participants
|
3.8 percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions
Swelling-Any (n=196,200,182,177,171,170,169,168)
|
13.3 percentage of participants
|
14.5 percentage of participants
|
22.0 percentage of participants
|
14.7 percentage of participants
|
23.4 percentage of participants
|
20.0 percentage of participants
|
26.6 percentage of participants
|
18.5 percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions
Swelling-Mild (n=196,200,182,177,171,170,166,168)
|
12.2 percentage of participants
|
13.0 percentage of participants
|
20.3 percentage of participants
|
13.0 percentage of participants
|
20.5 percentage of participants
|
17.1 percentage of participants
|
22.9 percentage of participants
|
16.0 percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions
Swelling-Mod (n=196,196,177,175,166,168,156,163)
|
2.6 percentage of participants
|
2.0 percentage of participants
|
2.3 percentage of participants
|
2.3 percentage of participants
|
6.6 percentage of participants
|
6.0 percentage of participants
|
9.0 percentage of participants
|
5.5 percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions
Swelling-Sev (n=196,196,177,175,166,168,152,156)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions
Redness-Any (n=197,199,181,180,172,172,170,169)
|
15.2 percentage of participants
|
15.1 percentage of participants
|
23.8 percentage of participants
|
20.0 percentage of participants
|
26.7 percentage of participants
|
22.7 percentage of participants
|
30.0 percentage of participants
|
23.1 percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions
Redness-Mild (n=197,198,180,180,172,171,167,165)
|
14.7 percentage of participants
|
14.1 percentage of participants
|
22.2 percentage of participants
|
19.4 percentage of participants
|
24.4 percentage of participants
|
21.1 percentage of participants
|
28.1 percentage of participants
|
21.2 percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions
Redness-Mod (n=196,197,178,175,166,169,157,163)
|
0.5 percentage of participants
|
1.0 percentage of participants
|
2.2 percentage of participants
|
1.1 percentage of participants
|
3.6 percentage of participants
|
3.6 percentage of participants
|
9.6 percentage of participants
|
6.7 percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions
Redness-Sev (n=196,196,177,175,166,168,152,156)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.6 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
OTHER_PRE_SPECIFIED 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 (Meds) to treat symptoms (Sx), and use of medication to prevent symptoms were reported using an electronic diary. Participants may be represented in more than 1 category.
Outcome measures
| Measure |
13vPnC After Infant Series Dose 2
n=218 Participants
Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits (infant series Dose 2).
|
7vPnC After Infant Series Dose 2
n=226 Participants
Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits (infant series Dose 2).
|
13vPnC Dose 2
n=217 Participants
Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at the 4-month visit.
|
7vPnC Dose 2
n=222 Participants
Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix hexa at the 4-month visit.
|
13vPnC Dose 3
n=214 Participants
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa and at the 6-month visit.
|
7vPnC Dose 3
n=221 Participants
Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa and at the 6-month visit.
|
13vPnC Toddler Dose
n=209 Participants
Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix-IPV+Hib at the 15-month visit.
|
7vPnC Toddler Dose
n=220 Participants
Participants received one single 0.5 mL dose of 7vPnC coadministered with with NeisVac-C and Infanrix-IPV+Hib at the 15-month visit.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Reporting Pre-Specified Systemic Events
Fv ≥38°C, ≤39°C(n=201,204,181,189,172,176,156,169)
|
22.9 percentage of participants
|
19.6 percentage of participants
|
32.6 percentage of participants
|
41.8 percentage of participants
|
20.9 percentage of participants
|
29.0 percentage of participants
|
31.4 percentage of participants
|
34.3 percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events
Fv >39°C, ≤40°C(n=196,196,177,176,166,168,154,156)
|
1.0 percentage of participants
|
0.5 percentage of participants
|
1.7 percentage of participants
|
1.1 percentage of participants
|
3.6 percentage of participants
|
3.0 percentage of participants
|
4.5 percentage of participants
|
2.6 percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events
Fv >40°C (n=196,197,177,175,166,168,152,156)
|
0.0 percentage of participants
|
0.5 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
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events
Decr appetite (n=204,207,189,191,178,178,163,178)
|
31.4 percentage of participants
|
35.7 percentage of participants
|
46.6 percentage of participants
|
44.0 percentage of participants
|
37.1 percentage of participants
|
36.0 percentage of participants
|
31.9 percentage of participants
|
41.0 percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events
Irritability (n=202,211,192,190,179,188,171,179)
|
46.5 percentage of participants
|
49.8 percentage of participants
|
57.3 percentage of participants
|
60.0 percentage of participants
|
43.0 percentage of participants
|
39.4 percentage of participants
|
41.5 percentage of participants
|
53.6 percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events
Incr sleep (n=204,206,189,187,175,174,162,165)
|
38.7 percentage of participants
|
39.3 percentage of participants
|
39.2 percentage of participants
|
36.4 percentage of participants
|
21.1 percentage of participants
|
27.0 percentage of participants
|
16.7 percentage of participants
|
24.8 percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events
Decr sleep (n=196,204,183,187,175,178,162,166)
|
19.4 percentage of participants
|
27.5 percentage of participants
|
27.3 percentage of participants
|
27.8 percentage of participants
|
22.9 percentage of participants
|
25.3 percentage of participants
|
19.8 percentage of participants
|
18.7 percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events
Meds-treat sx (n=205,209,193,197,175,189,165,177)
|
41.0 percentage of participants
|
44.5 percentage of participants
|
54.4 percentage of participants
|
57.9 percentage of participants
|
39.4 percentage of participants
|
42.9 percentage of participants
|
50.3 percentage of participants
|
46.9 percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events
Meds-prevent sx(n=201,210,194,196,177,185,168,177)
|
41.3 percentage of participants
|
45.7 percentage of participants
|
47.9 percentage of participants
|
49.5 percentage of participants
|
44.6 percentage of participants
|
40.5 percentage of participants
|
43.5 percentage of participants
|
41.8 percentage of participants
|
Adverse Events
13vPnC Infant Series
Serious events: 6 serious events
Other events: 204 other events
Deaths: 0 deaths
7vPnC Infant Series
Serious events: 8 serious events
Other events: 211 other events
Deaths: 0 deaths
13vPnC Post-Infant Series
Serious events: 9 serious events
Other events: 6 other events
Deaths: 0 deaths
7vPnC Post-Infant Series
Serious events: 6 serious events
Other events: 13 other events
Deaths: 0 deaths
13vPnC Toddler Series
Serious events: 1 serious events
Other events: 171 other events
Deaths: 0 deaths
7vPnC Toddler Series
Serious events: 0 serious events
Other events: 179 other events
Deaths: 0 deaths
13vPnC 6-Month Follow-up
Serious events: 4 serious events
Other events: 4 other events
Deaths: 0 deaths
7vPnC 6-Month Follow-up
Serious events: 9 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
13vPnC Infant Series
n=218 participants at risk
Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits. Adverse events were collected from dose 1 to approximately one month after dose 3.
|
7vPnC Infant Series
n=225 participants at risk；n=226 participants at risk
Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits. Adverse events were collected from dose 1 to approximately one month after dose 3.
|
13vPnC Post-Infant Series
n=218 participants at risk
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at the 6-month visit. Adverse events were collected from approximately one month after dose 3 to toddler dose.
|
7vPnC Post-Infant Series
n=225 participants at risk；n=226 participants at risk
Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at the 6-month visit. Adverse events were collected from approximately one month after dose 3 to toddler dose.
|
13vPnC Toddler Series
n=209 participants at risk；n=218 participants at risk
Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix-IPV+Hib at the 15-month visit. Adverse events were collected for approximately one month after toddler dose.
|
7vPnC Toddler Series
n=218 participants at risk；n=226 participants at risk
Participants received one single 0.5 mL dose of 7vPnC coadministered with with NeisVac-C and Infanrix-IPV+Hib at the 15-month visit. Adverse events were collected for approximately one month after toddler dose.
|
13vPnC 6-Month Follow-up
n=218 participants at risk
Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits (infant series Dose 2) and one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3). Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix IPV + Hib at the 15-month visit (toddler dose). MMR was administered without study vaccine at the 12-month visit. Adverse events were collected for approximately six months after last visit
|
7vPnC 6-Month Follow-up
n=224 participants at risk；n=226 participants at risk
Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits (infant series Dose 2) and one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3). Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix IPV + Hib at the 15-month visit (toddler dose). MMR was administered without study vaccine at the 12-month visit. Adverse events were collected for approximately six months after last visit
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.00%
0/218
|
0.00%
0/226
|
0.00%
0/218
|
0.00%
0/226
|
0.00%
0/218
|
0.00%
0/226
|
0.00%
0/218
|
0.44%
1/226
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/218
|
0.00%
0/226
|
0.46%
1/218
|
0.00%
0/226
|
0.00%
0/218
|
0.00%
0/226
|
0.00%
0/218
|
0.00%
0/226
|
|
Infections and infestations
Bacteriuria
|
0.00%
0/218
|
0.00%
0/226
|
0.00%
0/218
|
0.44%
1/226
|
0.00%
0/218
|
0.00%
0/226
|
0.00%
0/218
|
0.00%
0/226
|
|
Infections and infestations
Bronchiolitis
|
0.46%
1/218
|
0.88%
2/226
|
0.92%
2/218
|
0.00%
0/226
|
0.00%
0/218
|
0.00%
0/226
|
0.00%
0/218
|
0.00%
0/226
|
|
Infections and infestations
Bronchitis
|
0.00%
0/218
|
0.00%
0/226
|
0.46%
1/218
|
0.00%
0/226
|
0.00%
0/218
|
0.00%
0/226
|
0.00%
0/218
|
0.00%
0/226
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospams
|
0.00%
0/218
|
0.00%
0/226
|
0.00%
0/218
|
0.00%
0/226
|
0.00%
0/218
|
0.00%
0/226
|
0.46%
1/218
|
0.00%
0/226
|
|
Gastrointestinal disorders
Coleliac disease
|
0.00%
0/218
|
0.00%
0/226
|
0.00%
0/218
|
0.00%
0/226
|
0.00%
0/218
|
0.00%
0/226
|
0.00%
0/218
|
0.44%
1/226
|
|
Nervous system disorders
Convulsion
|
0.00%
0/218
|
0.00%
0/226
|
0.46%
1/218
|
0.00%
0/226
|
0.46%
1/218
|
0.00%
0/226
|
0.00%
0/218
|
0.00%
0/226
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/218
|
0.00%
0/226
|
0.46%
1/218
|
0.00%
0/226
|
0.00%
0/218
|
0.00%
0/226
|
0.00%
0/218
|
0.44%
1/226
|
|
Infections and infestations
Enterocolitis viral
|
0.00%
0/218
|
0.00%
0/226
|
0.46%
1/218
|
0.00%
0/226
|
0.00%
0/218
|
0.00%
0/226
|
0.00%
0/218
|
0.00%
0/226
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.46%
1/218
|
0.00%
0/226
|
0.00%
0/218
|
0.00%
0/226
|
0.00%
0/218
|
0.00%
0/226
|
0.00%
0/218
|
0.00%
0/226
|
|
Nervous system disorders
Febrile convulsion
|
0.00%
0/218
|
0.00%
0/226
|
0.46%
1/218
|
0.00%
0/226
|
0.00%
0/218
|
0.00%
0/226
|
0.00%
0/218
|
0.00%
0/226
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/218
|
0.00%
0/226
|
0.00%
0/218
|
0.00%
0/226
|
0.00%
0/218
|
0.00%
0/226
|
0.00%
0/218
|
0.44%
1/226
|
|
Infections and infestations
Gastroenteritis
|
0.46%
1/218
|
0.44%
1/226
|
0.00%
0/218
|
0.44%
1/226
|
0.00%
0/218
|
0.00%
0/226
|
0.00%
0/218
|
0.88%
2/226
|
|
Infections and infestations
Gastroenteritis rotavirus
|
0.00%
0/218
|
0.00%
0/226
|
0.00%
0/218
|
0.44%
1/226
|
0.00%
0/218
|
0.00%
0/226
|
0.00%
0/218
|
0.00%
0/226
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/218
|
0.44%
1/226
|
0.00%
0/218
|
0.00%
0/226
|
0.00%
0/218
|
0.00%
0/226
|
0.00%
0/218
|
0.00%
0/226
|
|
Respiratory, thoracic and mediastinal disorders
Increased bronchial secretion
|
0.00%
0/218
|
0.00%
0/226
|
0.00%
0/218
|
0.00%
0/226
|
0.00%
0/218
|
0.00%
0/226
|
0.00%
0/218
|
0.44%
1/226
|
|
Infections and infestations
Influenza
|
0.00%
0/218
|
0.00%
0/226
|
0.00%
0/218
|
0.00%
0/226
|
0.00%
0/218
|
0.00%
0/226
|
0.46%
1/218
|
0.00%
0/226
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/218
|
0.00%
0/226
|
0.00%
0/218
|
0.44%
1/226
|
0.00%
0/218
|
0.00%
0/226
|
0.00%
0/218
|
0.00%
0/226
|
|
Gastrointestinal disorders
Intussusception
|
0.00%
0/218
|
0.00%
0/226
|
0.00%
0/218
|
0.00%
0/226
|
0.00%
0/218
|
0.00%
0/226
|
0.00%
0/218
|
0.44%
1/226
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/218
|
0.00%
0/226
|
0.46%
1/218
|
0.00%
0/226
|
0.00%
0/218
|
0.00%
0/226
|
0.00%
0/218
|
0.00%
0/226
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/218
|
0.00%
0/226
|
0.00%
0/218
|
0.00%
0/226
|
0.00%
0/218
|
0.00%
0/226
|
0.00%
0/218
|
0.44%
1/226
|
|
Infections and infestations
Orchitis
|
0.46%
1/218
|
0.00%
0/226
|
0.00%
0/218
|
0.00%
0/226
|
0.00%
0/218
|
0.00%
0/226
|
0.00%
0/218
|
0.00%
0/226
|
|
Infections and infestations
Otitis media
|
0.00%
0/218
|
0.00%
0/226
|
0.00%
0/218
|
0.00%
0/226
|
0.00%
0/218
|
0.00%
0/226
|
0.00%
0/218
|
0.44%
1/226
|
|
Infections and infestations
Pharyngotonsillitis
|
0.00%
0/218
|
0.00%
0/226
|
0.00%
0/218
|
0.00%
0/226
|
0.00%
0/218
|
0.00%
0/226
|
0.00%
0/218
|
0.44%
1/226
|
|
Infections and infestations
Pneumonia
|
0.46%
1/218
|
0.00%
0/226
|
0.46%
1/218
|
0.44%
1/226
|
0.00%
0/218
|
0.00%
0/226
|
0.92%
2/218
|
0.00%
0/226
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/218
|
0.44%
1/226
|
0.00%
0/218
|
0.00%
0/226
|
0.00%
0/218
|
0.00%
0/226
|
0.00%
0/218
|
0.00%
0/226
|
|
General disorders
Pyrexia
|
0.46%
1/218
|
0.44%
1/226
|
0.46%
1/218
|
0.00%
0/226
|
0.46%
1/218
|
0.00%
0/226
|
0.00%
0/218
|
0.00%
0/226
|
|
Infections and infestations
Respiratory syncytial virus bronchiolitis
|
0.00%
0/218
|
0.00%
0/226
|
0.46%
1/218
|
0.00%
0/226
|
0.00%
0/218
|
0.00%
0/226
|
0.46%
1/218
|
0.44%
1/226
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/218
|
0.00%
0/226
|
0.00%
0/218
|
0.00%
0/226
|
0.00%
0/218
|
0.00%
0/226
|
0.00%
0/218
|
0.44%
1/226
|
|
Infections and infestations
Urinary tract infection
|
0.46%
1/218
|
0.44%
1/226
|
0.46%
1/218
|
0.44%
1/226
|
0.00%
0/218
|
0.00%
0/226
|
0.00%
0/218
|
0.00%
0/226
|
|
Infections and infestations
Viral infection
|
0.00%
0/218
|
0.44%
1/226
|
0.00%
0/218
|
0.00%
0/226
|
0.00%
0/218
|
0.00%
0/226
|
0.00%
0/218
|
0.00%
0/226
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.46%
1/218
|
0.00%
0/226
|
0.00%
0/218
|
0.00%
0/226
|
0.00%
0/218
|
0.00%
0/226
|
0.00%
0/218
|
0.00%
0/226
|
Other adverse events
| Measure |
13vPnC Infant Series
n=218 participants at risk
Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits. Adverse events were collected from dose 1 to approximately one month after dose 3.
|
7vPnC Infant Series
n=225 participants at risk；n=226 participants at risk
Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits. Adverse events were collected from dose 1 to approximately one month after dose 3.
|
13vPnC Post-Infant Series
n=218 participants at risk
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at the 6-month visit. Adverse events were collected from approximately one month after dose 3 to toddler dose.
|
7vPnC Post-Infant Series
n=225 participants at risk；n=226 participants at risk
Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at the 6-month visit. Adverse events were collected from approximately one month after dose 3 to toddler dose.
|
13vPnC Toddler Series
n=209 participants at risk；n=218 participants at risk
Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix-IPV+Hib at the 15-month visit. Adverse events were collected for approximately one month after toddler dose.
|
7vPnC Toddler Series
n=218 participants at risk；n=226 participants at risk
Participants received one single 0.5 mL dose of 7vPnC coadministered with with NeisVac-C and Infanrix-IPV+Hib at the 15-month visit. Adverse events were collected for approximately one month after toddler dose.
|
13vPnC 6-Month Follow-up
n=218 participants at risk
Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits (infant series Dose 2) and one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3). Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix IPV + Hib at the 15-month visit (toddler dose). MMR was administered without study vaccine at the 12-month visit. Adverse events were collected for approximately six months after last visit
|
7vPnC 6-Month Follow-up
n=224 participants at risk；n=226 participants at risk
Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits (infant series Dose 2) and one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3). Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix IPV + Hib at the 15-month visit (toddler dose). MMR was administered without study vaccine at the 12-month visit. Adverse events were collected for approximately six months after last visit
|
|---|---|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Burns third degree
|
0.46%
1/218
|
0.00%
0/225
|
0.00%
0/218
|
0.00%
0/225
|
0.00%
0/209
|
0.00%
0/218
|
0.00%
0/218
|
0.00%
0/224
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/218
|
0.00%
0/225
|
0.00%
0/218
|
0.00%
0/225
|
0.00%
0/209
|
0.46%
1/218
|
0.00%
0/218
|
0.00%
0/224
|
|
Congenital, familial and genetic disorders
Phimosis
|
0.00%
0/218
|
0.00%
0/225
|
0.00%
0/218
|
0.44%
1/225
|
0.00%
0/209
|
0.00%
0/218
|
0.00%
0/218
|
0.00%
0/224
|
|
Congenital, familial and genetic disorders
Thalassaemia beta
|
0.00%
0/218
|
0.00%
0/225
|
0.00%
0/218
|
0.00%
0/225
|
0.00%
0/209
|
0.00%
0/218
|
0.46%
1/218
|
0.00%
0/224
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/218
|
0.00%
0/225
|
0.00%
0/218
|
0.00%
0/225
|
0.48%
1/209
|
0.00%
0/218
|
0.00%
0/218
|
0.00%
0/224
|
|
Eye disorders
Conjunctivitis
|
1.4%
3/218
|
4.9%
11/225
|
0.00%
0/218
|
0.00%
0/225
|
0.00%
0/209
|
0.46%
1/218
|
0.00%
0/218
|
0.00%
0/224
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/218
|
0.44%
1/225
|
0.00%
0/218
|
0.00%
0/225
|
0.00%
0/209
|
0.00%
0/218
|
0.00%
0/218
|
0.00%
0/224
|
|
Eye disorders
Dacryostenosis acquired
|
0.46%
1/218
|
0.00%
0/225
|
0.00%
0/218
|
0.00%
0/225
|
0.00%
0/209
|
0.00%
0/218
|
0.00%
0/218
|
0.00%
0/224
|
|
Gastrointestinal disorders
Diarrhoea
|
3.7%
8/218
|
4.0%
9/225
|
0.00%
0/218
|
0.44%
1/225
|
0.96%
2/209
|
1.4%
3/218
|
0.00%
0/218
|
0.00%
0/224
|
|
Gastrointestinal disorders
Vomiting
|
1.4%
3/218
|
1.8%
4/225
|
0.00%
0/218
|
0.00%
0/225
|
0.00%
0/209
|
0.00%
0/218
|
0.00%
0/218
|
0.00%
0/224
|
|
Gastrointestinal disorders
Gastrointestinal inflammation
|
1.4%
3/218
|
0.89%
2/225
|
0.00%
0/218
|
0.00%
0/225
|
0.00%
0/209
|
0.00%
0/218
|
0.00%
0/218
|
0.00%
0/224
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/218
|
0.89%
2/225
|
0.00%
0/218
|
0.00%
0/225
|
0.00%
0/209
|
0.00%
0/218
|
0.00%
0/218
|
0.00%
0/224
|
|
Gastrointestinal disorders
Enteritis
|
0.46%
1/218
|
0.44%
1/225
|
0.00%
0/218
|
0.00%
0/225
|
0.00%
0/209
|
0.00%
0/218
|
0.00%
0/218
|
0.00%
0/224
|
|
Gastrointestinal disorders
Abnormal faeces
|
0.46%
1/218
|
0.00%
0/225
|
0.00%
0/218
|
0.00%
0/225
|
0.00%
0/209
|
0.00%
0/218
|
0.00%
0/218
|
0.00%
0/224
|
|
Gastrointestinal disorders
Infantile colic
|
0.00%
0/218
|
0.44%
1/225
|
0.00%
0/218
|
0.00%
0/225
|
0.00%
0/209
|
0.00%
0/218
|
0.00%
0/218
|
0.00%
0/224
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.00%
0/218
|
0.00%
0/225
|
0.00%
0/218
|
0.00%
0/225
|
0.00%
0/209
|
0.46%
1/218
|
0.00%
0/218
|
0.00%
0/224
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/218
|
0.00%
0/225
|
0.00%
0/218
|
0.00%
0/225
|
0.00%
0/209
|
0.46%
1/218
|
0.00%
0/218
|
0.00%
0/224
|
|
General disorders
Pyrexia
|
2.8%
6/218
|
4.0%
9/225
|
0.00%
0/218
|
0.00%
0/225
|
2.4%
5/209
|
0.92%
2/218
|
0.00%
0/218
|
0.00%
0/224
|
|
General disorders
Irritability
|
82.1%
179/218
|
83.6%
188/225
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
General disorders
Developmental delay
|
0.00%
0/218
|
0.00%
0/225
|
0.00%
0/218
|
0.44%
1/225
|
0.00%
0/209
|
0.00%
0/218
|
0.00%
0/218
|
0.00%
0/224
|
|
Immune system disorders
Milk allergy
|
0.46%
1/218
|
0.44%
1/225
|
0.00%
0/218
|
0.44%
1/225
|
0.00%
0/209
|
0.00%
0/218
|
0.00%
0/218
|
0.00%
0/224
|
|
Immune system disorders
Food allergy
|
0.00%
0/218
|
0.00%
0/225
|
0.46%
1/218
|
0.00%
0/225
|
0.00%
0/209
|
0.00%
0/218
|
0.46%
1/218
|
0.45%
1/224
|
|
Infections and infestations
Nasopharyngitis
|
9.6%
21/218
|
12.0%
27/225
|
0.00%
0/218
|
0.44%
1/225
|
4.3%
9/209
|
2.8%
6/218
|
0.00%
0/218
|
0.00%
0/224
|
|
Infections and infestations
Upper respiratory tract infection
|
10.6%
23/218
|
10.7%
24/225
|
0.46%
1/218
|
0.89%
2/225
|
2.4%
5/209
|
1.8%
4/218
|
0.00%
0/218
|
0.00%
0/224
|
|
Infections and infestations
Gastroenteritis
|
8.7%
19/218
|
6.7%
15/225
|
0.00%
0/218
|
0.00%
0/225
|
3.3%
7/209
|
1.4%
3/218
|
0.00%
0/218
|
0.00%
0/224
|
|
Infections and infestations
Bronchiolitis
|
5.5%
12/218
|
7.6%
17/225
|
0.00%
0/218
|
0.00%
0/225
|
0.48%
1/209
|
0.00%
0/218
|
0.00%
0/218
|
0.00%
0/224
|
|
Infections and infestations
Respiratory tract infection
|
4.1%
9/218
|
6.2%
14/225
|
0.00%
0/218
|
0.00%
0/225
|
0.00%
0/209
|
0.46%
1/218
|
0.00%
0/218
|
0.00%
0/224
|
|
Infections and infestations
Bronchitis
|
4.1%
9/218
|
5.8%
13/225
|
0.00%
0/218
|
0.44%
1/225
|
0.48%
1/209
|
0.46%
1/218
|
0.00%
0/218
|
0.00%
0/224
|
|
Infections and infestations
Laryngitis
|
2.3%
5/218
|
3.6%
8/225
|
0.00%
0/218
|
0.00%
0/225
|
0.48%
1/209
|
0.46%
1/218
|
0.00%
0/218
|
0.00%
0/224
|
|
Infections and infestations
Otitis media
|
1.4%
3/218
|
3.6%
8/225
|
0.00%
0/218
|
0.00%
0/225
|
0.00%
0/209
|
0.00%
0/218
|
0.00%
0/218
|
0.00%
0/224
|
|
Infections and infestations
Rhinitis
|
1.8%
4/218
|
3.1%
7/225
|
0.00%
0/218
|
0.00%
0/225
|
0.00%
0/209
|
0.00%
0/218
|
0.00%
0/218
|
0.00%
0/224
|
|
Infections and infestations
Ear infection
|
2.3%
5/218
|
2.2%
5/225
|
0.00%
0/218
|
0.44%
1/225
|
0.00%
0/209
|
2.3%
5/218
|
0.00%
0/218
|
0.00%
0/224
|
|
Infections and infestations
Pharyngitis
|
1.8%
4/218
|
0.89%
2/225
|
0.00%
0/218
|
0.00%
0/225
|
2.4%
5/209
|
1.4%
3/218
|
0.00%
0/218
|
0.00%
0/224
|
|
Infections and infestations
Tonsillitis
|
0.92%
2/218
|
1.3%
3/225
|
0.00%
0/218
|
0.00%
0/225
|
0.48%
1/209
|
1.8%
4/218
|
0.00%
0/218
|
0.00%
0/224
|
|
Infections and infestations
Viral infection
|
0.46%
1/218
|
1.8%
4/225
|
0.00%
0/218
|
0.00%
0/225
|
0.96%
2/209
|
0.00%
0/218
|
0.00%
0/218
|
0.00%
0/224
|
|
Infections and infestations
Candidiasis
|
0.46%
1/218
|
1.3%
3/225
|
0.00%
0/218
|
0.00%
0/225
|
0.00%
0/209
|
0.00%
0/218
|
0.00%
0/218
|
0.00%
0/224
|
|
Infections and infestations
Otitis media acute
|
0.46%
1/218
|
0.89%
2/225
|
0.00%
0/218
|
0.00%
0/225
|
0.96%
2/209
|
0.00%
0/218
|
0.00%
0/218
|
0.00%
0/224
|
|
Infections and infestations
Varicella
|
0.46%
1/218
|
0.89%
2/225
|
0.00%
0/218
|
0.44%
1/225
|
0.00%
0/209
|
0.00%
0/218
|
0.00%
0/218
|
0.00%
0/224
|
|
Infections and infestations
Oral candidiasis
|
0.46%
1/218
|
0.44%
1/225
|
0.00%
0/218
|
0.00%
0/225
|
0.00%
0/209
|
0.00%
0/218
|
0.00%
0/218
|
0.00%
0/224
|
|
Infections and infestations
Urinary tract infection
|
0.92%
2/218
|
0.00%
0/225
|
0.00%
0/218
|
0.00%
0/225
|
0.48%
1/209
|
0.46%
1/218
|
0.00%
0/218
|
0.00%
0/224
|
|
Infections and infestations
Bronchopneumonia
|
0.46%
1/218
|
0.00%
0/225
|
0.00%
0/218
|
0.00%
0/225
|
0.00%
0/209
|
0.00%
0/218
|
0.00%
0/218
|
0.00%
0/224
|
|
Infections and infestations
Campylobacter gastroenteritis
|
0.00%
0/218
|
0.44%
1/225
|
0.00%
0/218
|
0.00%
0/225
|
0.00%
0/209
|
0.00%
0/218
|
0.00%
0/218
|
0.00%
0/224
|
|
Infections and infestations
Campylobacter intestinal infection
|
0.46%
1/218
|
0.00%
0/225
|
0.00%
0/218
|
0.00%
0/225
|
0.00%
0/209
|
0.00%
0/218
|
0.00%
0/218
|
0.00%
0/224
|
|
Infections and infestations
Croup infectious
|
0.46%
1/218
|
0.00%
0/225
|
0.00%
0/218
|
0.00%
0/225
|
0.00%
0/209
|
0.00%
0/218
|
0.00%
0/218
|
0.00%
0/224
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.46%
1/218
|
0.00%
0/225
|
0.00%
0/218
|
0.00%
0/225
|
0.00%
0/209
|
0.00%
0/218
|
0.00%
0/218
|
0.00%
0/224
|
|
Infections and infestations
Exanthema subitum
|
0.46%
1/218
|
0.00%
0/225
|
0.00%
0/218
|
0.00%
0/225
|
0.00%
0/209
|
0.00%
0/218
|
0.00%
0/218
|
0.00%
0/224
|
|
Infections and infestations
Gastroenteritis rotavirus
|
0.00%
0/218
|
0.44%
1/225
|
0.00%
0/218
|
0.00%
0/225
|
0.00%
0/209
|
0.00%
0/218
|
0.00%
0/218
|
0.00%
0/224
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/218
|
0.44%
1/225
|
0.00%
0/218
|
0.00%
0/225
|
0.00%
0/209
|
0.46%
1/218
|
0.00%
0/218
|
0.00%
0/224
|
|
Infections and infestations
Herpangina
|
0.46%
1/218
|
0.00%
0/225
|
0.00%
0/218
|
0.00%
0/225
|
0.00%
0/209
|
0.00%
0/218
|
0.46%
1/218
|
0.00%
0/224
|
|
Infections and infestations
Paronychia
|
0.00%
0/218
|
0.44%
1/225
|
0.00%
0/218
|
0.00%
0/225
|
0.00%
0/209
|
0.00%
0/218
|
0.00%
0/218
|
0.00%
0/224
|
|
Infections and infestations
Pharyngotonsillitis
|
0.00%
0/218
|
0.44%
1/225
|
0.00%
0/218
|
0.00%
0/225
|
0.48%
1/209
|
0.00%
0/218
|
0.00%
0/218
|
0.00%
0/224
|
|
Infections and infestations
Pneumonia
|
0.46%
1/218
|
0.00%
0/225
|
0.00%
0/218
|
0.00%
0/225
|
0.00%
0/209
|
0.46%
1/218
|
0.00%
0/218
|
0.00%
0/224
|
|
Infections and infestations
Respiratory tract infection viral
|
0.46%
1/218
|
0.00%
0/225
|
0.00%
0/218
|
0.00%
0/225
|
0.00%
0/209
|
0.00%
0/218
|
0.00%
0/218
|
0.00%
0/224
|
|
Infections and infestations
Roseola
|
0.46%
1/218
|
0.00%
0/225
|
0.00%
0/218
|
0.00%
0/225
|
0.00%
0/209
|
0.46%
1/218
|
0.00%
0/218
|
0.00%
0/224
|
|
Infections and infestations
Viral skin infection
|
0.00%
0/218
|
0.44%
1/225
|
0.00%
0/218
|
0.00%
0/225
|
0.00%
0/209
|
0.00%
0/218
|
0.00%
0/218
|
0.00%
0/224
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.46%
1/218
|
0.00%
0/225
|
0.00%
0/218
|
0.00%
0/225
|
0.00%
0/209
|
0.00%
0/218
|
0.00%
0/218
|
0.00%
0/224
|
|
Infections and infestations
Acarodermatitis
|
0.00%
0/218
|
0.00%
0/225
|
0.00%
0/218
|
0.44%
1/225
|
0.00%
0/209
|
0.00%
0/218
|
0.00%
0/218
|
0.00%
0/224
|
|
Infections and infestations
Injection site abscess
|
0.00%
0/218
|
0.00%
0/225
|
0.46%
1/218
|
0.00%
0/225
|
0.00%
0/209
|
0.00%
0/218
|
0.00%
0/218
|
0.00%
0/224
|
|
Infections and infestations
Oral herpes
|
0.00%
0/218
|
0.00%
0/225
|
0.00%
0/218
|
0.00%
0/225
|
0.48%
1/209
|
0.46%
1/218
|
0.00%
0/218
|
0.00%
0/224
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/218
|
0.00%
0/225
|
0.00%
0/218
|
0.00%
0/225
|
0.00%
0/209
|
0.46%
1/218
|
0.00%
0/218
|
0.00%
0/224
|
|
Infections and infestations
Lice infestation
|
0.00%
0/218
|
0.00%
0/225
|
0.00%
0/218
|
0.00%
0/225
|
0.48%
1/209
|
0.00%
0/218
|
0.00%
0/218
|
0.00%
0/224
|
|
Infections and infestations
Viral rash
|
0.00%
0/218
|
0.00%
0/225
|
0.00%
0/218
|
0.00%
0/225
|
0.48%
1/209
|
0.00%
0/218
|
0.00%
0/218
|
0.00%
0/224
|
|
Injury, poisoning and procedural complications
Head injury
|
0.46%
1/218
|
0.44%
1/225
|
0.00%
0/218
|
0.00%
0/225
|
0.00%
0/209
|
0.46%
1/218
|
0.00%
0/218
|
0.00%
0/224
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/218
|
0.00%
0/225
|
0.00%
0/218
|
0.00%
0/225
|
0.96%
2/209
|
0.00%
0/218
|
0.00%
0/218
|
0.00%
0/224
|
|
Metabolism and nutrition disorders
Cow's milk intolerance
|
0.46%
1/218
|
0.44%
1/225
|
0.00%
0/218
|
0.44%
1/225
|
0.00%
0/209
|
0.00%
0/218
|
0.00%
0/218
|
0.00%
0/224
|
|
Metabolism and nutrition disorders
Anorexia
|
0.46%
1/218
|
0.00%
0/225
|
0.00%
0/218
|
0.00%
0/225
|
0.48%
1/209
|
0.00%
0/218
|
0.00%
0/218
|
0.00%
0/224
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.46%
1/218
|
0.00%
0/225
|
0.00%
0/218
|
0.00%
0/225
|
0.00%
0/209
|
0.00%
0/218
|
0.00%
0/218
|
0.00%
0/224
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm
|
0.46%
1/218
|
0.00%
0/225
|
0.00%
0/218
|
0.00%
0/225
|
0.00%
0/209
|
0.00%
0/218
|
0.00%
0/218
|
0.00%
0/224
|
|
Nervous system disorders
Somnolence
|
0.46%
1/218
|
0.00%
0/225
|
0.00%
0/218
|
0.00%
0/225
|
0.00%
0/209
|
0.00%
0/218
|
0.00%
0/218
|
0.00%
0/224
|
|
Psychiatric disorders
Restlessness
|
0.46%
1/218
|
0.00%
0/225
|
0.00%
0/218
|
0.00%
0/225
|
0.00%
0/209
|
0.00%
0/218
|
0.00%
0/218
|
0.00%
0/224
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.8%
4/218
|
0.89%
2/225
|
0.00%
0/218
|
0.00%
0/225
|
0.48%
1/209
|
0.00%
0/218
|
0.00%
0/218
|
0.00%
0/224
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.46%
1/218
|
2.2%
5/225
|
0.00%
0/218
|
0.00%
0/225
|
0.00%
0/209
|
0.00%
0/218
|
0.00%
0/218
|
0.00%
0/224
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
1.4%
3/218
|
1.3%
3/225
|
0.46%
1/218
|
0.00%
0/225
|
0.00%
0/209
|
0.00%
0/218
|
0.00%
0/218
|
0.00%
0/224
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.46%
1/218
|
0.44%
1/225
|
0.00%
0/218
|
0.00%
0/225
|
0.00%
0/209
|
0.00%
0/218
|
0.00%
0/218
|
0.00%
0/224
|
|
Respiratory, thoracic and mediastinal disorders
Asphyxia
|
0.46%
1/218
|
0.00%
0/225
|
0.00%
0/218
|
0.00%
0/225
|
0.00%
0/209
|
0.00%
0/218
|
0.00%
0/218
|
0.00%
0/224
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.46%
1/218
|
0.00%
0/225
|
0.46%
1/218
|
0.00%
0/225
|
0.00%
0/209
|
0.00%
0/218
|
0.00%
0/218
|
0.45%
1/224
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.46%
1/218
|
0.00%
0/225
|
0.00%
0/218
|
0.00%
0/225
|
0.00%
0/209
|
0.00%
0/218
|
0.00%
0/218
|
0.00%
0/224
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.46%
1/218
|
0.00%
0/225
|
0.00%
0/218
|
0.00%
0/225
|
0.00%
0/209
|
0.00%
0/218
|
0.00%
0/218
|
0.00%
0/224
|
|
Respiratory, thoracic and mediastinal disorders
Infantile asthma
|
0.00%
0/218
|
0.00%
0/225
|
0.00%
0/218
|
0.00%
0/225
|
0.00%
0/209
|
0.00%
0/218
|
0.46%
1/218
|
0.00%
0/224
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
1.4%
3/218
|
1.3%
3/225
|
0.46%
1/218
|
0.89%
2/225
|
0.00%
0/209
|
0.00%
0/218
|
0.00%
0/218
|
0.00%
0/224
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/218
|
2.7%
6/225
|
0.00%
0/218
|
0.00%
0/225
|
0.48%
1/209
|
0.00%
0/218
|
0.00%
0/218
|
0.00%
0/224
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
1.4%
3/218
|
0.00%
0/225
|
0.00%
0/218
|
0.00%
0/225
|
0.00%
0/209
|
0.46%
1/218
|
0.00%
0/218
|
0.00%
0/224
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.46%
1/218
|
0.89%
2/225
|
0.00%
0/218
|
0.00%
0/225
|
0.48%
1/209
|
0.46%
1/218
|
0.00%
0/218
|
0.00%
0/224
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/218
|
0.44%
1/225
|
0.00%
0/218
|
0.00%
0/225
|
0.00%
0/209
|
0.00%
0/218
|
0.00%
0/218
|
0.00%
0/224
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
0.00%
0/218
|
0.00%
0/225
|
0.00%
0/218
|
0.00%
0/225
|
0.48%
1/209
|
0.00%
0/218
|
0.00%
0/218
|
0.00%
0/224
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/218
|
0.00%
0/225
|
0.00%
0/218
|
0.00%
0/225
|
0.48%
1/209
|
0.00%
0/218
|
0.00%
0/218
|
0.00%
0/224
|
|
Skin and subcutaneous tissue disorders
Tenderness (any)
|
78.0%
170/218
|
77.8%
175/225
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
Skin and subcutaneous tissue disorders
Tenderness (significant)
|
76.6%
167/218
|
75.1%
169/225
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
Skin and subcutaneous tissue disorders
Induration (any)
|
78.4%
171/218
|
75.6%
170/225
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
Skin and subcutaneous tissue disorders
Induration (mild)
|
78.4%
171/218
|
75.6%
170/225
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
Skin and subcutaneous tissue disorders
Induration (moderate)
|
76.1%
166/218
|
74.7%
168/225
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
Skin and subcutaneous tissue disorders
Induration (severe)
|
76.1%
166/218
|
74.7%
168/225
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
Skin and subcutaneous tissue disorders
Erythema (any)
|
78.9%
172/218
|
76.4%
172/225
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
Skin and subcutaneous tissue disorders
Erythema (mild)
|
78.9%
172/218
|
76.0%
171/225
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
Skin and subcutaneous tissue disorders
Erythema (moderate)
|
76.1%
166/218
|
75.1%
169/225
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
Skin and subcutaneous tissue disorders
Erythema (severe)
|
76.1%
166/218
|
74.7%
168/225
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
General disorders
Fever ≥38°C but ≤39°C
|
78.9%
172/218
|
78.2%
176/225
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
General disorders
Fever >39°C but ≤40°C
|
76.1%
166/218
|
74.7%
168/225
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
General disorders
Fever >40°C
|
76.1%
166/218
|
74.7%
168/225
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
General disorders
Decreased appetite
|
81.7%
178/218
|
79.1%
178/225
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
General disorders
Increased sleep
|
80.3%
175/218
|
77.3%
174/225
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
General disorders
Decreased sleep
|
80.3%
175/218
|
79.1%
178/225
|
—
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