Trial Outcomes & Findings for Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants (NCT NCT00384059)
NCT ID: NCT00384059
Last Updated: 2013-01-24
Results Overview
Percentage of participants achieving a meningococcal C SBA serum antibody titer ≥1:8 and predefined antibody threshold levels with the corresponding 95% CI for concomitant antigens polyribosylribitol phosphate (PRP) in haemophilus influenzae type b \[Hib\](≥0.15 μg/mL or ≥ 1.0 μg/mL), pertussis toxoid \[PT\], filamentous haemagglutinin, pertactin \[FHA\], and pertactin (PRN) (≥5 Elisa Units EU/mL) and fimbrial agglutinogens \[FIM\] (≥2.2 EU/mL) are presented.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
286 participants
Primary outcome timeframe
One month after infant series dose 2 (5 months of age)
Results posted on
2013-01-24
Participant Flow
Participants were recruited in the United Kingdom (UK) from October 2006 to June 2007.
Participants were enrolled into the study according to inclusion/exclusion criteria without a screening period.
Participant milestones
| Measure |
13vPnC
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
|
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 a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 7vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
|
|---|---|---|
|
Infant Series
STARTED
|
141
|
145
|
|
Infant Series
Vaccinated Dose 1
|
139
|
139
|
|
Infant Series
Vaccinated Dose 2
|
136
|
135
|
|
Infant Series
COMPLETED
|
135
|
132
|
|
Infant Series
NOT COMPLETED
|
6
|
13
|
|
After Infant Series
STARTED
|
135
|
132
|
|
After Infant Series
COMPLETED
|
131
|
122
|
|
After Infant Series
NOT COMPLETED
|
4
|
10
|
|
Toddler Dose
STARTED
|
131
|
122
|
|
Toddler Dose
COMPLETED
|
130
|
120
|
|
Toddler Dose
NOT COMPLETED
|
1
|
2
|
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 a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
|
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 a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 7vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
|
|---|---|---|
|
Infant Series
Not consented
|
2
|
6
|
|
Infant Series
Withdrawal by Subject
|
2
|
2
|
|
Infant Series
Adverse Event
|
1
|
2
|
|
Infant Series
Protocol Violation
|
1
|
2
|
|
Infant Series
Lost to Follow-up
|
0
|
1
|
|
After Infant Series
Protocol Violation
|
2
|
3
|
|
After Infant Series
Withdrawal by Subject
|
2
|
2
|
|
After Infant Series
Failed to Return
|
0
|
2
|
|
After Infant Series
Adverse Event
|
0
|
1
|
|
After Infant Series
Physician Decision
|
0
|
1
|
|
After Infant Series
Lost to Follow-up
|
0
|
1
|
|
Toddler Dose
Lost to Follow-up
|
1
|
1
|
|
Toddler Dose
Failed to return
|
0
|
1
|
Baseline Characteristics
Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants
Baseline characteristics by cohort
| Measure |
13vPnC
n=120 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 a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
|
7vPnC
n=118 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 a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 7vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
|
Total
n=238 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
2.1 months
STANDARD_DEVIATION 0.3 • n=5 Participants
|
2.1 months
STANDARD_DEVIATION 0.2 • n=7 Participants
|
2.1 months
STANDARD_DEVIATION 0.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
112 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
65 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
126 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: One month after infant series dose 2 (5 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 postinfant series antibody concentration to the given concomitant antigen.
Percentage of participants achieving a meningococcal C SBA serum antibody titer ≥1:8 and predefined antibody threshold levels with the corresponding 95% CI for concomitant antigens polyribosylribitol phosphate (PRP) in haemophilus influenzae type b \[Hib\](≥0.15 μg/mL or ≥ 1.0 μg/mL), pertussis toxoid \[PT\], filamentous haemagglutinin, pertactin \[FHA\], and pertactin (PRN) (≥5 Elisa Units EU/mL) and fimbrial agglutinogens \[FIM\] (≥2.2 EU/mL) are presented.
Outcome measures
| Measure |
13vPnC
n=120 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 a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
|
7vPnC
n=118 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 a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 7vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
|
13vPnC After Toddler Dose
Participants received Menitorix at the 12-month visit.
|
7vPnC After Toddler Dose
Participants received Menitorix at the 12-month visit.
|
13vPnC Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with Menitorix at 12 months of age.
|
7vPnC Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with Menitorix at 12 months of age.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving a Meningococcal C Serum Bactericidal Assay (SBA) Titer ≥1:8 and Predefined Antibody Levels for Pertussis and Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series.
Meningococcal C ≥ 1:8 titer (n=120,118)
|
99.2 Percentage of participants
Interval 95.4 to 100.0
|
99.2 Percentage of participants
Interval 95.4 to 100.0
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving a Meningococcal C Serum Bactericidal Assay (SBA) Titer ≥1:8 and Predefined Antibody Levels for Pertussis and Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series.
Hib (PRP) ≥ 0.15 μg/mL (n=114,102)
|
96.5 Percentage of participants
Interval 91.3 to 99.0
|
98.0 Percentage of participants
Interval 93.1 to 99.8
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving a Meningococcal C Serum Bactericidal Assay (SBA) Titer ≥1:8 and Predefined Antibody Levels for Pertussis and Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series.
Hib (PRP) ≥ 1.0 μg/mL (n=114,102)
|
85.1 Percentage of participants
Interval 77.2 to 91.1
|
89.2 Percentage of participants
Interval 81.5 to 94.5
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving a Meningococcal C Serum Bactericidal Assay (SBA) Titer ≥1:8 and Predefined Antibody Levels for Pertussis and Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series.
Pertussis PT ≥ 17 EU/mL (n=119,112)
|
96.6 Percentage of participants
Interval 91.6 to 99.1
|
95.5 Percentage of participants
Interval 89.9 to 98.5
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving a Meningococcal C Serum Bactericidal Assay (SBA) Titer ≥1:8 and Predefined Antibody Levels for Pertussis and Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series.
Pertussis FHA ≥ 5 EU/mL (n=119,113)
|
100.0 Percentage of participants
Interval 96.9 to 100.0
|
100.0 Percentage of participants
Interval 96.8 to 100.0
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving a Meningococcal C Serum Bactericidal Assay (SBA) Titer ≥1:8 and Predefined Antibody Levels for Pertussis and Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series.
Pertussis FHA ≥ 20 EU/mL (n=119,113)
|
94.1 Percentage of participants
Interval 88.3 to 97.6
|
95.6 Percentage of participants
Interval 90.0 to 98.5
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving a Meningococcal C Serum Bactericidal Assay (SBA) Titer ≥1:8 and Predefined Antibody Levels for Pertussis and Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series.
Pertussis PRN ≥ 15 EU/mL (n=119,113)
|
92.4 Percentage of participants
Interval 86.1 to 96.5
|
95.6 Percentage of participants
Interval 90.0 to 98.5
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving a Meningococcal C Serum Bactericidal Assay (SBA) Titer ≥1:8 and Predefined Antibody Levels for Pertussis and Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series.
Pertussis FIM ≥ 2.2 EU/mL (n=119,113)
|
100.0 Percentage of participants
Interval 96.9 to 100.0
|
97.3 Percentage of participants
Interval 92.4 to 99.4
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving a Meningococcal C Serum Bactericidal Assay (SBA) Titer ≥1:8 and Predefined Antibody Levels for Pertussis and Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series.
Pertussis PT ≥ 5 EU/mL (n=119,112)
|
100.0 Percentage of participants
Interval 96.9 to 100.0
|
100.0 Percentage of participants
Interval 96.8 to 100.0
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving a Meningococcal C Serum Bactericidal Assay (SBA) Titer ≥1:8 and Predefined Antibody Levels for Pertussis and Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series.
Pertussis FHA ≥ 7.82 EU/mL (n=119,113)
|
100.0 Percentage of participants
Interval 96.9 to 100.0
|
100.0 Percentage of participants
Interval 96.8 to 100.0
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving a Meningococcal C Serum Bactericidal Assay (SBA) Titer ≥1:8 and Predefined Antibody Levels for Pertussis and Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series.
Pertussis PRN ≥ 5 EU/mL (n=119,113)
|
100.0 Percentage of participants
Interval 96.9 to 100.0
|
100.0 Percentage of participants
Interval 96.8 to 100.0
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving a Meningococcal C Serum Bactericidal Assay (SBA) Titer ≥1:8 and Predefined Antibody Levels for Pertussis and Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series.
Pertussis FIM ≥ 5 EU/mL (n=119,113)
|
97.5 Percentage of participants
Interval 92.8 to 99.5
|
96.5 Percentage of participants
Interval 91.2 to 99.0
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: one month after infant series dose 2 (5 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 antibody concentration/titer for the specified concomitant antigen.
Outcome measures
| Measure |
13vPnC
n=120 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 a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
|
7vPnC
n=118 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 a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 7vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
|
13vPnC After Toddler Dose
Participants received Menitorix at the 12-month visit.
|
7vPnC After Toddler Dose
Participants received Menitorix at the 12-month visit.
|
13vPnC Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with Menitorix at 12 months of age.
|
7vPnC Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with Menitorix at 12 months of age.
|
|---|---|---|---|---|---|---|
|
Geometric Mean Titer (GMT) of Meningococcal C Antigen as Measured by SBA in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series
|
306.20 titer
Interval 251.21 to 373.22
|
345.42 titer
Interval 287.91 to 414.41
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: one month after infant series dose 2 (5 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 antibody concentration/titer for the specified concomitant antigen.
Outcome measures
| Measure |
13vPnC
n=114 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 a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
|
7vPnC
n=102 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 a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 7vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
|
13vPnC After Toddler Dose
Participants received Menitorix at the 12-month visit.
|
7vPnC After Toddler Dose
Participants received Menitorix at the 12-month visit.
|
13vPnC Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with Menitorix at 12 months of age.
|
7vPnC Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with Menitorix at 12 months of age.
|
|---|---|---|---|---|---|---|
|
Geometric Mean Antibody Concentration of Haemophilus Influenzae Type b (Hib) Polyribosylribitol Phosphate (PRP) as Measured by Enzyme-linked Immunosorbent Assay (ELISA) in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series
|
3.40 μg/mL
Interval 2.65 to 4.37
|
4.44 μg/mL
Interval 3.5 to 5.63
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: one month after infant series dose 2 (5 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 antibody concentration/titer for the specified concomitant antigen.
Outcome measures
| Measure |
13vPnC
n=120 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 a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
|
7vPnC
n=118 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 a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 7vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
|
13vPnC After Toddler Dose
Participants received Menitorix at the 12-month visit.
|
7vPnC After Toddler Dose
Participants received Menitorix at the 12-month visit.
|
13vPnC Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with Menitorix at 12 months of age.
|
7vPnC Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with Menitorix at 12 months of age.
|
|---|---|---|---|---|---|---|
|
Geometric Mean Antibody Concentration of Pertusis Filamentous Haemagglutinin (FHA), Pertussis Toxoid (PT), Pertactin (PRN), and Fimbrial Agglutinogens (FIM) as Measured by ELISA in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series
Pertussis FHA (n=119,113)
|
54.74 EU/mL
Interval 48.25 to 373.22
|
55.99 EU/mL
Interval 49.55 to 414.41
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration of Pertusis Filamentous Haemagglutinin (FHA), Pertussis Toxoid (PT), Pertactin (PRN), and Fimbrial Agglutinogens (FIM) as Measured by ELISA in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series
Pertussis PT (n=119,112)
|
66.26 EU/mL
Interval 59.2 to 74.16
|
67.05 EU/mL
Interval 58.75 to 76.52
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration of Pertusis Filamentous Haemagglutinin (FHA), Pertussis Toxoid (PT), Pertactin (PRN), and Fimbrial Agglutinogens (FIM) as Measured by ELISA in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series
Pertussis PRN (n=119,113)
|
61.33 EU/mL
Interval 51.78 to 72.65
|
61.07 EU/mL
Interval 52.31 to 71.3
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration of Pertusis Filamentous Haemagglutinin (FHA), Pertussis Toxoid (PT), Pertactin (PRN), and Fimbrial Agglutinogens (FIM) as Measured by ELISA in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series
Pertussis FIM (n=119,113)
|
21.72 EU/mL
Interval 18.89 to 24.98
|
21.77 EU/mL
Interval 18.54 to 25.56
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: one month after infant series dose 2 (5 months of age), before and after toddler dose (12 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 igG antibody concentration to the given serotype.
Percentages of participants achieving 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
n=120 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 a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
|
7vPnC
n=120 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 a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 7vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
|
13vPnC After Toddler Dose
n=110 Participants
Participants received Menitorix at the 12-month visit.
|
7vPnC After Toddler Dose
Participants received Menitorix at the 12-month visit.
|
13vPnC Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with Menitorix at 12 months of age.
|
7vPnC Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with Menitorix at 12 months of age.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants in the 13vPnC Group Achieving a Serotype-specific IgG Antibody Concentration ≥0.35 µg/mL Measured 1 Month After the 2-dose Infant Series, Before and After the Toddler Dose
Common Serotypes - Serotype 4 (n=107,89,102)
|
95.3 Percentage of Participants
Interval 89.4 to 98.5
|
24.7 Percentage of Participants
Interval 16.2 to 35.0
|
99.0 Percentage of Participants
Interval 94.7 to 100.0
|
—
|
—
|
—
|
|
Percentage of Participants in the 13vPnC Group Achieving a Serotype-specific IgG Antibody Concentration ≥0.35 µg/mL Measured 1 Month After the 2-dose Infant Series, Before and After the Toddler Dose
Common Serotypes - Serotype 6B (n=107,86,102)
|
40.2 Percentage of Participants
Interval 30.8 to 50.1
|
74.4 Percentage of Participants
Interval 63.9 to 83.2
|
98.0 Percentage of Participants
Interval 93.1 to 99.8
|
—
|
—
|
—
|
|
Percentage of Participants in the 13vPnC Group Achieving a Serotype-specific IgG Antibody Concentration ≥0.35 µg/mL Measured 1 Month After the 2-dose Infant Series, Before and After the Toddler Dose
Common Serotypes - Serotype 9V (n=104,91,101)
|
85.6 Percentage of Participants
Interval 77.3 to 91.7
|
44.0 Percentage of Participants
Interval 33.6 to 54.8
|
98.0 Percentage of Participants
Interval 93.0 to 99.8
|
—
|
—
|
—
|
|
Percentage of Participants in the 13vPnC Group Achieving a Serotype-specific IgG Antibody Concentration ≥0.35 µg/mL Measured 1 Month After the 2-dose Infant Series, Before and After the Toddler Dose
Common Serotypes - Serotype 14 (n=107,88,101)
|
92.5 Percentage of Participants
Interval 85.8 to 96.7
|
92.0 Percentage of Participants
Interval 84.3 to 96.7
|
100.0 Percentage of Participants
Interval 96.4 to 100.0
|
—
|
—
|
—
|
|
Percentage of Participants in the 13vPnC Group Achieving a Serotype-specific IgG Antibody Concentration ≥0.35 µg/mL Measured 1 Month After the 2-dose Infant Series, Before and After the Toddler Dose
Common Serotypes - Serotype 18C (n=111,91,105)
|
92.8 Percentage of Participants
Interval 86.3 to 96.8
|
13.2 Percentage of Participants
Interval 7.0 to 21.9
|
97.1 Percentage of Participants
Interval 91.9 to 99.4
|
—
|
—
|
—
|
|
Percentage of Participants in the 13vPnC Group Achieving a Serotype-specific IgG Antibody Concentration ≥0.35 µg/mL Measured 1 Month After the 2-dose Infant Series, Before and After the Toddler Dose
Common Serotypes - Serotype 19F (n=109,91,104)
|
93.6 Percentage of Participants
Interval 87.2 to 97.4
|
67.0 Percentage of Participants
Interval 56.4 to 76.5
|
98.1 Percentage of Participants
Interval 93.2 to 99.8
|
—
|
—
|
—
|
|
Percentage of Participants in the 13vPnC Group Achieving a Serotype-specific IgG Antibody Concentration ≥0.35 µg/mL Measured 1 Month After the 2-dose Infant Series, Before and After the Toddler Dose
Common Serotypes - Serotype 23F (n=111,89,104)
|
66.7 Percentage of Participants
Interval 57.1 to 75.3
|
37.1 Percentage of Participants
Interval 27.1 to 48.0
|
98.1 Percentage of Participants
Interval 93.2 to 99.8
|
—
|
—
|
—
|
|
Percentage of Participants in the 13vPnC Group Achieving a Serotype-specific IgG Antibody Concentration ≥0.35 µg/mL Measured 1 Month After the 2-dose Infant Series, Before and After the Toddler Dose
Additional Serotypes - Serotype 1 (n=107,88,101)
|
97.2 Percentage of Participants
Interval 92.0 to 99.4
|
50.0 Percentage of Participants
Interval 39.1 to 60.9
|
100.0 Percentage of Participants
Interval 96.4 to 100.0
|
—
|
—
|
—
|
|
Percentage of Participants in the 13vPnC Group Achieving a Serotype-specific IgG Antibody Concentration ≥0.35 µg/mL Measured 1 Month After the 2-dose Infant Series, Before and After the Toddler Dose
Additional Serotypes - Serotype 5 (n=103,88,101)
|
89.3 Percentage of Participants
Interval 81.7 to 94.5
|
78.4 Percentage of Participants
Interval 68.4 to 86.5
|
100.0 Percentage of Participants
Interval 96.4 to 100.0
|
—
|
—
|
—
|
|
Percentage of Participants in the 13vPnC Group Achieving a Serotype-specific IgG Antibody Concentration ≥0.35 µg/mL Measured 1 Month After the 2-dose Infant Series, Before and After the Toddler Dose
Additional Serotypes - Serotype 6A (n=106,86,99)
|
79.2 Percentage of Participants
Interval 70.3 to 86.5
|
79.1 Percentage of Participants
Interval 69.0 to 87.1
|
98.0 Percentage of Participants
Interval 92.9 to 99.8
|
—
|
—
|
—
|
|
Percentage of Participants in the 13vPnC Group Achieving a Serotype-specific IgG Antibody Concentration ≥0.35 µg/mL Measured 1 Month After the 2-dose Infant Series, Before and After the Toddler Dose
Additional Serotypes - Serotype 7F (n=107,91,100)
|
94.4 Percentage of Participants
Interval 88.2 to 97.9
|
71.4 Percentage of Participants
Interval 61.0 to 80.4
|
100.0 Percentage of Participants
Interval 96.4 to 100.0
|
—
|
—
|
—
|
|
Percentage of Participants in the 13vPnC Group Achieving a Serotype-specific IgG Antibody Concentration ≥0.35 µg/mL Measured 1 Month After the 2-dose Infant Series, Before and After the Toddler Dose
Additional Serotypes - Serotype 19A (n=110,91,103)
|
92.7 Percentage of Participants
Interval 86.2 to 96.8
|
86.8 Percentage of Participants
Interval 78.1 to 93.0
|
100.0 Percentage of Participants
Interval 96.5 to 100.0
|
—
|
—
|
—
|
|
Percentage of Participants in the 13vPnC Group Achieving a Serotype-specific IgG Antibody Concentration ≥0.35 µg/mL Measured 1 Month After the 2-dose Infant Series, Before and After the Toddler Dose
Additional Serotypes - Serotype 3 (n=107,87,102)
|
86.0 Percentage of Participants
Interval 77.9 to 91.9
|
12.6 Percentage of Participants
Interval 6.5 to 21.5
|
88.2 Percentage of Participants
Interval 80.4 to 93.8
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: one month after infant series dose 2 (5 months of age) and before and after toddler dose (12 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 antibody concentration for the specified serotype.
Antibody concentration/geometric mean concentration (GMC) as measured by 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 with corresponding 2-sided 95% CI.
Outcome measures
| Measure |
13vPnC
n=120 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 a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
|
7vPnC
n=120 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 a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 7vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
|
13vPnC After Toddler Dose
n=110 Participants
Participants received Menitorix at the 12-month visit.
|
7vPnC After Toddler Dose
Participants received Menitorix at the 12-month visit.
|
13vPnC Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with Menitorix at 12 months of age.
|
7vPnC Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with Menitorix at 12 months of age.
|
|---|---|---|---|---|---|---|
|
Geometric Mean Antibody Concentration in 13vPnC Group After the 2-dose Infant Series, Before and After the Toddler Dose.
Common Serotypes - Serotype 4 (n=107,87,87)
|
1.37 μg/mL
Interval 1.16 to 1.62
|
0.21 μg/mL
Interval 0.17 to 0.24
|
3.52 μg/mL
Interval 2.91 to 4.26
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration in 13vPnC Group After the 2-dose Infant Series, Before and After the Toddler Dose.
Common Serotypes - Serotype 6B (n=107,85,85)
|
0.26 μg/mL
Interval 0.21 to 0.33
|
0.77 μg/mL
Interval 0.6 to 0.99
|
7.67 μg/mL
Interval 5.88 to 10.01
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration in 13vPnC Group After the 2-dose Infant Series, Before and After the Toddler Dose.
Common Serotypes - Serotype 14 (n=107,87,87)
|
1.83 μg/mL
Interval 1.47 to 2.27
|
1.34 μg/mL
Interval 1.09 to 1.66
|
11.32 μg/mL
Interval 9.27 to 13.83
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration in 13vPnC Group After the 2-dose Infant Series, Before and After the Toddler Dose.
Common Serotypes - Serotype 18C (n=111,91,91)
|
1.37 μg/mL
Interval 1.14 to 1.64
|
0.20 μg/mL
Interval 0.17 to 0.23
|
2.14 μg/mL
Interval 1.82 to 2.53
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration in 13vPnC Group After the 2-dose Infant Series, Before and After the Toddler Dose.
Common Serotypes - Serotype 19F (n=109,90,90)
|
2.38 μg/mL
Interval 1.88 to 3.01
|
0.60 μg/mL
Interval 0.46 to 0.79
|
7.25 μg/mL
Interval 5.65 to 9.31
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration in 13vPnC Group After the 2-dose Infant Series, Before and After the Toddler Dose.
Additional Serotypes - Serotype 7F (n=107,87,87)
|
2.14 μg/mL
Interval 1.75 to 2.62
|
0.56 μg/mL
Interval 0.48 to 0.66
|
4.06 μg/mL
Interval 3.42 to 4.83
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration in 13vPnC Group After the 2-dose Infant Series, Before and After the Toddler Dose.
Additional Serotypes - Serotype 19A (n=110,89,89)
|
1.90 μg/mL
Interval 1.54 to 2.34
|
1.01 μg/mL
Interval 0.77 to 1.32
|
11.33 μg/mL
Interval 9.29 to 13.83
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration in 13vPnC Group After the 2-dose Infant Series, Before and After the Toddler Dose.
Common Serotypes - Serotype 9V (n=104,88,88)
|
0.87 μg/mL
Interval 0.72 to 1.05
|
0.29 μg/mL
Interval 0.24 to 0.36
|
2.46 μg/mL
Interval 2.03 to 2.99
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration in 13vPnC Group After the 2-dose Infant Series, Before and After the Toddler Dose.
Common Serotypes - Serotype 23F (n=111,88,88)
|
0.53 μg/mL
Interval 0.42 to 0.67
|
0.24 μg/mL
Interval 0.19 to 0.32
|
3.13 μg/mL
Interval 2.59 to 3.78
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration in 13vPnC Group After the 2-dose Infant Series, Before and After the Toddler Dose.
Additional Serotypes - Serotype 1 (n=107,85,85)
|
1.69 μg/mL
Interval 1.41 to 2.04
|
0.39 μg/mL
Interval 0.33 to 0.46
|
5.60 μg/mL
Interval 4.6 to 6.82
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration in 13vPnC Group After the 2-dose Infant Series, Before and After the Toddler Dose.
Additional Serotypes - Serotype 3 (n=107,85,85)
|
0.63 μg/mL
Interval 0.56 to 0.71
|
0.14 μg/mL
Interval 0.1 to 0.18
|
0.98 μg/mL
Interval 0.78 to 1.22
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration in 13vPnC Group After the 2-dose Infant Series, Before and After the Toddler Dose.
Additional Serotypes - Serotype 5 (n=103,86,86)
|
0.95 μg/mL
Interval 0.79 to 1.14
|
0.59 μg/mL
Interval 0.49 to 0.72
|
3.68 μg/mL
Interval 3.04 to 4.45
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration in 13vPnC Group After the 2-dose Infant Series, Before and After the Toddler Dose.
Additional Serotypes - Serotype 6A (n=106,83,83)
|
0.86 μg/mL
Interval 0.68 to 1.07
|
0.81 μg/mL
Interval 0.64 to 1.03
|
6.31 μg/mL
Interval 5.06 to 7.87
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: one month after the toddler dose (13 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 posttoddler dose antibody concentration to the given concomitant antigen.
Outcome measures
| Measure |
13vPnC
n=102 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 a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
|
7vPnC
n=93 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 a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 7vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
|
13vPnC After Toddler Dose
n=109 Participants
Participants received Menitorix at the 12-month visit.
|
7vPnC After Toddler Dose
n=98 Participants
Participants received Menitorix at the 12-month visit.
|
13vPnC Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with Menitorix at 12 months of age.
|
7vPnC Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with Menitorix at 12 months of age.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving an SBA Titer ≥1:8 for Meningococcal C in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose.
|
44.1 Percentage of Participants
Interval 34.3 to 54.3
|
49.5 Percentage of Participants
Interval 38.9 to 60.0
|
91.7 Percentage of Participants
Interval 84.9 to 96.2
|
91.8 Percentage of Participants
Interval 84.5 to 96.4
|
—
|
—
|
SECONDARY outcome
Timeframe: one month after toddler dose (13 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 posttoddler dose antibody concentration to the given concomitant antigen.
Outcome measures
| Measure |
13vPnC
n=105 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 a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
|
7vPnC
n=96 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 a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 7vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
|
13vPnC After Toddler Dose
Participants received Menitorix at the 12-month visit.
|
7vPnC After Toddler Dose
Participants received Menitorix at the 12-month visit.
|
13vPnC Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with Menitorix at 12 months of age.
|
7vPnC Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with Menitorix at 12 months of age.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving a Predefined Antibody Level for Haemophilus Influenzae Type b in the 13vPnC Group Relative to the 7vPnC Group After the Toddler Dose.
Hib (PRP) ≥0.15 μg/mL
|
100.0 Percentage of Participants
Interval 96.5 to 100.0
|
100.0 Percentage of Participants
Interval 96.2 to 100.0
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving a Predefined Antibody Level for Haemophilus Influenzae Type b in the 13vPnC Group Relative to the 7vPnC Group After the Toddler Dose.
Hib (PRP)≥1.0 μg/mL
|
99.0 Percentage of Participants
Interval 94.8 to 100.0
|
100.0 Percentage of Participants
Interval 96.2 to 100.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: one month after toddler dose (13 months of age)Population: Evaluable immunogenicity (per protocol) population of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (N) = number of participants with a determinate antibody concentration/titer to the specific concomitant antigen.
Outcome measures
| Measure |
13vPnC
n=105 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 a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
|
7vPnC
n=96 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 a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 7vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
|
13vPnC After Toddler Dose
Participants received Menitorix at the 12-month visit.
|
7vPnC After Toddler Dose
Participants received Menitorix at the 12-month visit.
|
13vPnC Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with Menitorix at 12 months of age.
|
7vPnC Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with Menitorix at 12 months of age.
|
|---|---|---|---|---|---|---|
|
Geometric Mean Antibody Concentration for Haemophilus Influenzae Type b PRP in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose.
|
22.22 μg/mL
Interval 17.66 to 27.96
|
19.75 μg/mL
Interval 16.05 to 24.3
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: one month after toddler dose (13 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 antibody concentration/titer for the specified concomitant antigen.
Outcome measures
| Measure |
13vPnC
n=109 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 a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
|
7vPnC
n=98 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 a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 7vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
|
13vPnC After Toddler Dose
Participants received Menitorix at the 12-month visit.
|
7vPnC After Toddler Dose
Participants received Menitorix at the 12-month visit.
|
13vPnC Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with Menitorix at 12 months of age.
|
7vPnC Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with Menitorix at 12 months of age.
|
|---|---|---|---|---|---|---|
|
Geometric Mean Titer (GMT) of Meningococcal C Antigen as Measured by SBA in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose
|
656.11 titer
Interval 445.46 to 966.38
|
771.67 titer
Interval 509.98 to 1167.64
|
—
|
—
|
—
|
—
|
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 reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 centimeters \[cm\] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (\> 7.0 cm). Participants may be represented in more than 1 category.
Outcome measures
| Measure |
13vPnC
n=139 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 a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
|
7vPnC
n=139 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 a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 7vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
|
13vPnC After Toddler Dose
n=136 Participants
Participants received Menitorix at the 12-month visit.
|
7vPnC After Toddler Dose
n=135 Participants
Participants received Menitorix at the 12-month visit.
|
13vPnC Toddler Dose
n=131 Participants
Participants received one single 0.5 mL dose of 13vPnC coadministered with Menitorix at 12 months of age.
|
7vPnC Toddler Dose
n=122 Participants
Participants received one single 0.5 mL dose of 7vPnC coadministered with Menitorix at 12 months of age.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Reporting Pre-Specified Local Reactions
Tenderness-Any (n=123,127,114,96,87,71)
|
44.7 Percentage of Participants
|
43.3 Percentage of Participants
|
42.1 Percentage of Participants
|
40.6 Percentage of Participants
|
44.8 Percentage of Participants
|
50.7 Percentage of Participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions
Tenderness-Significant (n=116,122,97,89,77,58)
|
1.7 Percentage of Participants
|
6.6 Percentage of Participants
|
4.1 Percentage of Participants
|
4.5 Percentage of Participants
|
3.9 Percentage of Participants
|
3.4 Percentage of Participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions
Swelling-Any (n=121,126,106,93,83,68)
|
24.8 Percentage of Participants
|
29.4 Percentage of Participants
|
30.2 Percentage of Participants
|
34.4 Percentage of Participants
|
30.1 Percentage of Participants
|
39.7 Percentage of Participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions
Swelling-Mild (n=120,125,105,93,82,66)
|
21.7 Percentage of Participants
|
27.2 Percentage of Participants
|
28.6 Percentage of Participants
|
29.0 Percentage of Participants
|
28.0 Percentage of Participants
|
34.8 Percentage of Participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions
Swelling-Moderate (n=118,121,98,88,77,60)
|
6.8 Percentage of Participants
|
6.6 Percentage of Participants
|
8.2 Percentage of Participants
|
6.8 Percentage of Participants
|
3.9 Percentage of Participants
|
11.7 Percentage of Participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions
Swelling-Severe (n=115,119,96,88,76,57)
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
1.0 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=122,126,107,99,85,73)
|
22.1 Percentage of Participants
|
39.7 Percentage of Participants
|
39.3 Percentage of Participants
|
40.4 Percentage of Participants
|
38.8 Percentage of Participants
|
53.4 Percentage of Participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions
Redness-Mild (n=122,126,106,99,83,71)
|
21.3 Percentage of Participants
|
39.7 Percentage of Participants
|
37.7 Percentage of Participants
|
37.4 Percentage of Participants
|
33.7 Percentage of Participants
|
49.3 Percentage of Participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions
Redness-Moderate (n=116,119,98,88,78,61)
|
1.7 Percentage of Participants
|
0.0 Percentage of Participants
|
4.1 Percentage of Participants
|
3.4 Percentage of Participants
|
12.8 Percentage of Participants
|
16.4 Percentage of Participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions
Redness-Severe (n=115,119,97,88,76,57)
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
2.1 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: 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.
Systemic events (fever ≥ 38 degrees Celsius \[C\] but ≤ 39 C, fever \>39 C but ≤ 40 C, fever \> 40 C, decreased appetite, irritability, increased sleep, decreased sleep, use of medication (Meds) to prevent symptoms, and use of medication to treat symptoms) were collected using an electronic diary; percentage of participants with each event was evaluated.
Outcome measures
| Measure |
13vPnC
n=139 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 a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
|
7vPnC
n=139 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 a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 7vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
|
13vPnC After Toddler Dose
n=136 Participants
Participants received Menitorix at the 12-month visit.
|
7vPnC After Toddler Dose
n=135 Participants
Participants received Menitorix at the 12-month visit.
|
13vPnC Toddler Dose
n=131 Participants
Participants received one single 0.5 mL dose of 13vPnC coadministered with Menitorix at 12 months of age.
|
7vPnC Toddler Dose
n=122 Participants
Participants received one single 0.5 mL dose of 7vPnC coadministered with Menitorix at 12 months of age.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Reporting Pre-Specified Systemic Events
Fever ≥38°C but ≤39°C (n=116,119,96,88,78,61)
|
6.0 Percentage of Participants
|
3.4 Percentage of Participants
|
3.1 Percentage of Participants
|
4.5 Percentage of Participants
|
7.7 Percentage of Participants
|
16.4 Percentage of Participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events
Fever >39°C but ≤40°C (n=115,119,95,88,76,58)
|
0.9 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
5.2 Percentage of Participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events
Fever >40°C (n=115,119,96,88,76,57)
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
2.1 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events
Decreased appetite (n=120,129,104,98,92,68)
|
39.2 Percentage of Participants
|
34.1 Percentage of Participants
|
35.6 Percentage of Participants
|
37.8 Percentage of Participants
|
39.1 Percentage of Participants
|
44.1 Percentage of Participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events
Increased sleep (n=129,129,114,109,88,71)
|
69.8 Percentage of Participants
|
66.7 Percentage of Participants
|
51.8 Percentage of Participants
|
56.9 Percentage of Participants
|
38.6 Percentage of Participants
|
40.8 Percentage of Participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events
Decreased sleep (n=119,124,98,100,81,67)
|
32.8 Percentage of Participants
|
33.9 Percentage of Participants
|
35.7 Percentage of Participants
|
38.0 Percentage of Participants
|
32.1 Percentage of Participants
|
44.8 Percentage of Participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events
Meds to treat symptoms (n=123,128,108,110,85,72)
|
43.9 Percentage of Participants
|
40.6 Percentage of Participants
|
50.9 Percentage of Participants
|
54.5 Percentage of Participants
|
49.4 Percentage of Participants
|
58.3 Percentage of Participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events
Meds to prevent symptoms (n=122,124,117,103,92,77)
|
49.2 Percentage of Participants
|
40.3 Percentage of Participants
|
48.7 Percentage of Participants
|
50.5 Percentage of Participants
|
52.2 Percentage of Participants
|
67.5 Percentage of Participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events
Irritability (n=128,135,117,119,97,80)
|
76.6 Percentage of Participants
|
74.1 Percentage of Participants
|
71.8 Percentage of Participants
|
80.7 Percentage of Participants
|
74.2 Percentage of Participants
|
76.3 Percentage of Participants
|
Adverse Events
13vPnC Infant Series
Serious events: 1 serious events
Other events: 111 other events
Deaths: 0 deaths
7vPnC Infant Series
Serious events: 3 serious events
Other events: 105 other events
Deaths: 0 deaths
13vPnC Post-Infant Series
Serious events: 5 serious events
Other events: 9 other events
Deaths: 0 deaths
7vPnC Post-Infant Series
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
13vPnC Toddler Series
Serious events: 1 serious events
Other events: 72 other events
Deaths: 0 deaths
7vPnC Toddler Series
Serious events: 2 serious events
Other events: 61 other events
Deaths: 0 deaths
13vPnC 6-Month Follow-up
Serious events: 2 serious events
Other events: 1 other events
Deaths: 0 deaths
7vPnC 6-Month Follow-up
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
13vPnC Infant Series
n=138 participants at risk；n=139 participants at risk
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 a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits. Pediacel was administered without study vaccine at 3-month visit.
|
7vPnC Infant Series
n=139 participants at risk
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 a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits. Pediacel was administered without study vaccine at 3-month visit.
|
13vPnC Post-Infant Series
n=138 participants at risk；n=139 participants at risk
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 a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (assessment at 5 months of age, 1 month after the infant series). Pediacel was administered without study vaccine at 3-month visit.
|
7vPnC Post-Infant Series
n=139 participants at risk
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 a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (assessment at 5 months of age, 1 month after the infant series). Pediacel was administered without study vaccine at 3-month visit.
|
13vPnC Toddler Series
n=130 participants at risk；n=131 participants at risk
Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
|
7vPnC Toddler Series
n=122 participants at risk
Participants recieved one single 0.5 mL dose of 7vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
|
13vPnC 6-Month Follow-up
n=138 participants at risk
Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Haemophilus Influenzae Type b (Hib) \& Meningococcal C Vaccine (Menitorix) at the 12-month visit (assessment at 18 months of age, 6 months after the toddler dose).
|
7vPnC 6-Month Follow-up
n=139 participants at risk
Participants recieved one single 0.5 mL dose of 7vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit(assessment at 18 months of age, 6 months after the toddler dose).
|
|---|---|---|---|---|---|---|---|---|
|
Psychiatric disorders
Breath holding
|
0.00%
0/139
|
0.72%
1/139
|
0.00%
0/139
|
0.00%
0/139
|
0.00%
0/131
|
0.00%
0/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Infections and infestations
Bronchiolitis
|
0.72%
1/139
|
0.00%
0/139
|
0.72%
1/139
|
0.00%
0/139
|
0.76%
1/131
|
0.00%
0/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Infections and infestations
Cellulitis
|
0.00%
0/139
|
0.72%
1/139
|
0.00%
0/139
|
0.00%
0/139
|
0.00%
0/131
|
0.00%
0/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/139
|
0.00%
0/139
|
0.00%
0/139
|
0.00%
0/139
|
0.00%
0/131
|
0.82%
1/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Nervous system disorders
Febrile convulsion
|
0.00%
0/139
|
0.00%
0/139
|
0.00%
0/139
|
0.00%
0/139
|
0.00%
0/131
|
0.00%
0/122
|
0.72%
1/138
|
0.00%
0/139
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/139
|
0.00%
0/139
|
0.72%
1/139
|
0.00%
0/139
|
0.00%
0/131
|
0.00%
0/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Gastrointestinal disorders
Gastrooesophaegeal reflux
|
0.00%
0/139
|
0.72%
1/139
|
0.00%
0/139
|
0.00%
0/139
|
0.00%
0/131
|
0.00%
0/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/139
|
0.00%
0/139
|
0.72%
1/139
|
0.00%
0/139
|
0.00%
0/131
|
0.00%
0/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Nervous system disorders
Hemiplegia
|
0.00%
0/139
|
0.00%
0/139
|
0.00%
0/139
|
0.72%
1/139
|
0.00%
0/131
|
0.00%
0/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/139
|
0.72%
1/139
|
0.00%
0/139
|
0.00%
0/139
|
0.00%
0/131
|
0.00%
0/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Infections and infestations
Mastoiditis
|
0.00%
0/139
|
0.00%
0/139
|
0.00%
0/139
|
0.72%
1/139
|
0.00%
0/131
|
0.00%
0/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Infections and infestations
Pneumonia
|
0.00%
0/139
|
0.00%
0/139
|
0.00%
0/139
|
0.00%
0/139
|
0.00%
0/131
|
0.82%
1/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Injury, poisoning and procedural complications
Tongue injury
|
0.00%
0/139
|
0.00%
0/139
|
0.72%
1/139
|
0.00%
0/139
|
0.00%
0/131
|
0.00%
0/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/139
|
0.00%
0/139
|
0.00%
0/139
|
0.00%
0/139
|
0.00%
0/131
|
0.00%
0/122
|
0.72%
1/138
|
0.00%
0/139
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/139
|
0.00%
0/139
|
0.72%
1/139
|
0.00%
0/139
|
0.00%
0/131
|
0.00%
0/122
|
0.00%
0/138
|
0.00%
0/139
|
Other adverse events
| Measure |
13vPnC Infant Series
n=138 participants at risk；n=139 participants at risk
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 a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits. Pediacel was administered without study vaccine at 3-month visit.
|
7vPnC Infant Series
n=139 participants at risk
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 a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits. Pediacel was administered without study vaccine at 3-month visit.
|
13vPnC Post-Infant Series
n=138 participants at risk；n=139 participants at risk
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 a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (assessment at 5 months of age, 1 month after the infant series). Pediacel was administered without study vaccine at 3-month visit.
|
7vPnC Post-Infant Series
n=139 participants at risk
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 a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (assessment at 5 months of age, 1 month after the infant series). Pediacel was administered without study vaccine at 3-month visit.
|
13vPnC Toddler Series
n=130 participants at risk；n=131 participants at risk
Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
|
7vPnC Toddler Series
n=122 participants at risk
Participants recieved one single 0.5 mL dose of 7vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
|
13vPnC 6-Month Follow-up
n=138 participants at risk
Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Haemophilus Influenzae Type b (Hib) \& Meningococcal C Vaccine (Menitorix) at the 12-month visit (assessment at 18 months of age, 6 months after the toddler dose).
|
7vPnC 6-Month Follow-up
n=139 participants at risk
Participants recieved one single 0.5 mL dose of 7vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit(assessment at 18 months of age, 6 months after the toddler dose).
|
|---|---|---|---|---|---|---|---|---|
|
Eye disorders
Conjunctivitis
|
5.1%
7/138
|
9.4%
13/139
|
0.00%
0/138
|
0.00%
0/139
|
2.3%
3/130
|
3.3%
4/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Eye disorders
Eye discharge
|
3.6%
5/138
|
2.2%
3/139
|
0.00%
0/138
|
0.00%
0/139
|
0.00%
0/130
|
0.00%
0/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/138
|
0.72%
1/139
|
0.00%
0/138
|
0.00%
0/139
|
0.00%
0/130
|
0.00%
0/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Cardiac disorders
Cyanosis
|
1.4%
2/138
|
0.00%
0/139
|
0.00%
0/138
|
0.00%
0/139
|
0.00%
0/130
|
0.00%
0/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Congenital, familial and genetic disorders
Dacryostenosis congenital
|
0.00%
0/138
|
0.72%
1/139
|
0.00%
0/138
|
0.00%
0/139
|
0.00%
0/130
|
0.00%
0/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Congenital, familial and genetic disorders
Lymphangioma
|
0.00%
0/138
|
0.00%
0/139
|
0.72%
1/138
|
0.00%
0/139
|
0.00%
0/130
|
0.00%
0/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.00%
0/138
|
0.72%
1/139
|
0.00%
0/138
|
0.00%
0/139
|
0.00%
0/130
|
0.00%
0/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Ear and labyrinth disorders
Tympanic membrane perforation
|
0.00%
0/138
|
0.00%
0/139
|
0.00%
0/138
|
0.00%
0/139
|
0.00%
0/130
|
0.82%
1/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Eye disorders
Ocular hyperaemia
|
0.72%
1/138
|
0.72%
1/139
|
0.00%
0/138
|
0.00%
0/139
|
0.00%
0/130
|
0.00%
0/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Eye disorders
Astigmatism
|
0.00%
0/138
|
0.72%
1/139
|
0.00%
0/138
|
0.00%
0/139
|
0.00%
0/130
|
0.00%
0/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Eye disorders
Dacryostenosis acquired
|
0.72%
1/138
|
0.00%
0/139
|
0.00%
0/138
|
0.00%
0/139
|
0.00%
0/130
|
0.00%
0/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Eye disorders
Hypermetropia
|
0.00%
0/138
|
0.72%
1/139
|
0.00%
0/138
|
0.00%
0/139
|
0.00%
0/130
|
0.00%
0/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Gastrointestinal disorders
Diarrhoea
|
17.4%
24/138
|
12.2%
17/139
|
0.00%
0/138
|
0.00%
0/139
|
9.2%
12/130
|
10.7%
13/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Gastrointestinal disorders
Vomiting
|
13.8%
19/138
|
7.9%
11/139
|
0.00%
0/138
|
0.00%
0/139
|
9.2%
12/130
|
10.7%
13/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Gastrointestinal disorders
Teething
|
8.0%
11/138
|
6.5%
9/139
|
0.00%
0/138
|
0.00%
0/139
|
3.1%
4/130
|
2.5%
3/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
3.6%
5/138
|
1.4%
2/139
|
0.00%
0/138
|
0.00%
0/139
|
0.00%
0/130
|
0.00%
0/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Gastrointestinal disorders
Constipation
|
0.72%
1/138
|
1.4%
2/139
|
0.00%
0/138
|
0.00%
0/139
|
0.00%
0/130
|
0.00%
0/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Gastrointestinal disorders
Infantile spitting up
|
0.72%
1/138
|
0.72%
1/139
|
0.00%
0/138
|
0.00%
0/139
|
0.00%
0/130
|
0.00%
0/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Gastrointestinal disorders
Stomach discomfort
|
1.4%
2/138
|
0.00%
0/139
|
0.00%
0/138
|
0.00%
0/139
|
0.00%
0/130
|
0.00%
0/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.72%
1/138
|
0.00%
0/139
|
0.00%
0/138
|
0.00%
0/139
|
0.00%
0/130
|
0.00%
0/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Gastrointestinal disorders
Abdominal pain
|
0.72%
1/138
|
0.00%
0/139
|
0.00%
0/138
|
0.00%
0/139
|
0.00%
0/130
|
0.00%
0/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Gastrointestinal disorders
Flatulence
|
0.72%
1/138
|
0.00%
0/139
|
0.00%
0/138
|
0.00%
0/139
|
0.00%
0/130
|
0.00%
0/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.72%
1/138
|
0.00%
0/139
|
0.00%
0/138
|
0.00%
0/139
|
0.00%
0/130
|
0.00%
0/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Gastrointestinal disorders
Reflux oesophagitis
|
0.72%
1/138
|
0.00%
0/139
|
0.00%
0/138
|
0.00%
0/139
|
0.00%
0/130
|
0.00%
0/122
|
0.00%
0/138
|
0.00%
0/139
|
|
General disorders
Pyrexia
|
6.5%
9/138
|
5.0%
7/139
|
0.00%
0/138
|
0.00%
0/139
|
3.8%
5/130
|
4.9%
6/122
|
0.00%
0/138
|
0.00%
0/139
|
|
General disorders
Injection site erythema
|
0.72%
1/138
|
1.4%
2/139
|
0.00%
0/138
|
0.00%
0/139
|
0.00%
0/130
|
0.00%
0/122
|
0.00%
0/138
|
0.00%
0/139
|
|
General disorders
Feeling hot
|
0.00%
0/138
|
0.72%
1/139
|
0.00%
0/138
|
0.00%
0/139
|
0.00%
0/130
|
0.00%
0/122
|
0.00%
0/138
|
0.00%
0/139
|
|
General disorders
Injection site bruising
|
0.72%
1/138
|
0.00%
0/139
|
0.00%
0/138
|
0.00%
0/139
|
0.00%
0/130
|
0.82%
1/122
|
0.00%
0/138
|
0.00%
0/139
|
|
General disorders
Injection site induration
|
0.72%
1/138
|
0.00%
0/139
|
0.00%
0/138
|
0.00%
0/139
|
0.00%
0/130
|
0.00%
0/122
|
0.00%
0/138
|
0.00%
0/139
|
|
General disorders
Injection site swelling
|
0.00%
0/138
|
0.72%
1/139
|
0.00%
0/138
|
0.00%
0/139
|
0.00%
0/130
|
0.00%
0/122
|
0.00%
0/138
|
0.00%
0/139
|
|
General disorders
Irritability
|
71.8%
84/117
|
80.7%
96/119
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
General disorders
Malaise
|
0.00%
0/138
|
0.72%
1/139
|
0.00%
0/138
|
0.00%
0/139
|
0.00%
0/130
|
0.00%
0/122
|
0.00%
0/138
|
0.00%
0/139
|
|
General disorders
Vessel puncture site haematoma
|
0.00%
0/138
|
0.00%
0/139
|
0.00%
0/138
|
0.00%
0/139
|
0.77%
1/130
|
0.00%
0/122
|
0.00%
0/138
|
0.00%
0/139
|
|
General disorders
Gait disturbance
|
0.00%
0/138
|
0.00%
0/139
|
0.00%
0/138
|
0.00%
0/139
|
0.00%
0/130
|
0.00%
0/122
|
0.72%
1/138
|
0.00%
0/139
|
|
Immune system disorders
Food allergy
|
0.00%
0/138
|
0.00%
0/139
|
0.72%
1/138
|
0.00%
0/139
|
0.00%
0/130
|
0.00%
0/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/138
|
0.00%
0/139
|
0.00%
0/138
|
0.00%
0/139
|
0.77%
1/130
|
0.00%
0/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Infections and infestations
Rhinitis
|
23.2%
32/138
|
18.7%
26/139
|
0.72%
1/138
|
0.00%
0/139
|
8.5%
11/130
|
8.2%
10/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Infections and infestations
Upper respiratory tract infection
|
11.6%
16/138
|
13.7%
19/139
|
0.00%
0/138
|
0.72%
1/139
|
3.1%
4/130
|
3.3%
4/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Infections and infestations
Nasopharyngitis
|
10.9%
15/138
|
10.1%
14/139
|
0.00%
0/138
|
0.72%
1/139
|
6.9%
9/130
|
6.6%
8/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Infections and infestations
Lower respiratory tract infection
|
5.1%
7/138
|
2.9%
4/139
|
0.00%
0/138
|
0.00%
0/139
|
6.2%
8/130
|
1.6%
2/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Infections and infestations
Varicella
|
1.4%
2/138
|
5.8%
8/139
|
0.00%
0/138
|
0.00%
0/139
|
0.77%
1/130
|
0.00%
0/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Infections and infestations
Gastroenteritis
|
3.6%
5/138
|
2.9%
4/139
|
0.00%
0/138
|
0.00%
0/139
|
0.00%
0/130
|
0.82%
1/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Infections and infestations
Oral candidiasis
|
3.6%
5/138
|
1.4%
2/139
|
0.00%
0/138
|
0.00%
0/139
|
0.00%
0/130
|
0.82%
1/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Infections and infestations
Viral infection
|
2.9%
4/138
|
1.4%
2/139
|
0.00%
0/138
|
0.00%
0/139
|
1.5%
2/130
|
1.6%
2/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Infections and infestations
Herpes zoster
|
1.4%
2/138
|
1.4%
2/139
|
0.00%
0/138
|
0.00%
0/139
|
0.00%
0/130
|
0.00%
0/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Infections and infestations
Injection site infection
|
0.72%
1/138
|
1.4%
2/139
|
0.00%
0/138
|
0.00%
0/139
|
0.00%
0/130
|
0.00%
0/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Infections and infestations
Viral skin infection
|
1.4%
2/138
|
0.72%
1/139
|
0.00%
0/138
|
0.00%
0/139
|
0.00%
0/130
|
0.00%
0/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/138
|
1.4%
2/139
|
0.00%
0/138
|
0.72%
1/139
|
0.77%
1/130
|
0.82%
1/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Infections and infestations
Ear infection
|
0.00%
0/138
|
1.4%
2/139
|
0.00%
0/138
|
0.00%
0/139
|
3.8%
5/130
|
2.5%
3/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Infections and infestations
Eczema infected
|
1.4%
2/138
|
0.00%
0/139
|
0.00%
0/138
|
0.00%
0/139
|
0.00%
0/130
|
0.00%
0/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Infections and infestations
Otitis media
|
0.72%
1/138
|
0.72%
1/139
|
0.72%
1/138
|
0.72%
1/139
|
0.77%
1/130
|
1.6%
2/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Infections and infestations
Candidiasis
|
0.00%
0/138
|
0.72%
1/139
|
0.00%
0/138
|
0.00%
0/139
|
0.00%
0/130
|
0.00%
0/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Infections and infestations
Dermatitis infected
|
0.00%
0/138
|
0.72%
1/139
|
0.00%
0/138
|
0.00%
0/139
|
0.00%
0/130
|
0.00%
0/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Infections and infestations
Impetigo
|
0.00%
0/138
|
0.72%
1/139
|
0.00%
0/138
|
0.00%
0/139
|
1.5%
2/130
|
0.00%
0/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Infections and infestations
Respiratory tract infection
|
0.72%
1/138
|
0.00%
0/139
|
0.00%
0/138
|
0.00%
0/139
|
0.00%
0/130
|
0.00%
0/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Infections and infestations
Skin candida
|
0.00%
0/138
|
0.72%
1/139
|
0.00%
0/138
|
0.00%
0/139
|
0.00%
0/130
|
0.00%
0/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Infections and infestations
Tonsillitis
|
0.72%
1/138
|
0.00%
0/139
|
0.00%
0/138
|
0.00%
0/139
|
0.77%
1/130
|
0.00%
0/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/138
|
0.72%
1/139
|
0.00%
0/138
|
0.00%
0/139
|
0.77%
1/130
|
0.82%
1/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Infections and infestations
Rubella
|
0.00%
0/138
|
0.00%
0/139
|
0.72%
1/138
|
0.00%
0/139
|
0.00%
0/130
|
0.00%
0/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/138
|
0.00%
0/139
|
0.00%
0/138
|
0.00%
0/139
|
0.00%
0/130
|
1.6%
2/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Infections and infestations
Bronchitis
|
0.00%
0/138
|
0.00%
0/139
|
0.00%
0/138
|
0.00%
0/139
|
0.77%
1/130
|
0.00%
0/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Infections and infestations
Eye infection
|
0.00%
0/138
|
0.00%
0/139
|
0.00%
0/138
|
0.00%
0/139
|
0.77%
1/130
|
0.00%
0/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/138
|
0.00%
0/139
|
0.00%
0/138
|
0.00%
0/139
|
0.00%
0/130
|
0.82%
1/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Infections and infestations
Skin infection
|
0.00%
0/138
|
0.00%
0/139
|
0.00%
0/138
|
0.00%
0/139
|
0.77%
1/130
|
0.00%
0/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Injury, poisoning and procedural complications
Contusion
|
0.72%
1/138
|
0.72%
1/139
|
0.00%
0/138
|
0.00%
0/139
|
0.00%
0/130
|
0.00%
0/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Injury, poisoning and procedural complications
Head injury
|
1.4%
2/138
|
0.00%
0/139
|
0.00%
0/138
|
0.00%
0/139
|
0.00%
0/130
|
0.00%
0/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.72%
1/138
|
0.00%
0/139
|
0.00%
0/138
|
0.00%
0/139
|
0.00%
0/130
|
0.00%
0/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/138
|
0.00%
0/139
|
0.00%
0/138
|
0.00%
0/139
|
0.77%
1/130
|
0.00%
0/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Investigations
Physical examination abnormal
|
0.00%
0/138
|
0.72%
1/139
|
0.00%
0/138
|
0.00%
0/139
|
0.00%
0/130
|
0.00%
0/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Investigations
Cardiac murmur
|
0.00%
0/138
|
0.00%
0/139
|
0.00%
0/138
|
0.00%
0/139
|
0.77%
1/130
|
0.00%
0/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.72%
1/138
|
0.72%
1/139
|
0.00%
0/138
|
0.00%
0/139
|
0.77%
1/130
|
0.00%
0/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Metabolism and nutrition disorders
Anorexia
|
0.72%
1/138
|
0.00%
0/139
|
0.00%
0/138
|
0.00%
0/139
|
0.00%
0/130
|
0.00%
0/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/138
|
0.72%
1/139
|
0.00%
0/138
|
0.00%
0/139
|
0.00%
0/130
|
0.00%
0/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Metabolism and nutrition disorders
Weight gain poor
|
0.72%
1/138
|
0.00%
0/139
|
0.00%
0/138
|
0.00%
0/139
|
0.00%
0/130
|
0.00%
0/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Metabolism and nutrition disorders
Lactose intolerance
|
0.00%
0/138
|
0.00%
0/139
|
0.00%
0/138
|
0.00%
0/139
|
0.77%
1/130
|
0.00%
0/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Nervous system disorders
High-pitched crying
|
0.72%
1/138
|
0.72%
1/139
|
0.00%
0/138
|
0.00%
0/139
|
0.00%
0/130
|
0.00%
0/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Nervous system disorders
Somnolence
|
0.72%
1/138
|
0.72%
1/139
|
0.00%
0/138
|
0.00%
0/139
|
0.00%
0/130
|
0.00%
0/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Nervous system disorders
Hypertonia
|
0.72%
1/138
|
0.00%
0/139
|
0.00%
0/138
|
0.00%
0/139
|
0.00%
0/130
|
0.00%
0/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Nervous system disorders
Lethargy
|
0.00%
0/138
|
0.00%
0/139
|
0.00%
0/138
|
0.00%
0/139
|
0.00%
0/130
|
0.82%
1/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Psychiatric disorders
Crying
|
1.4%
2/138
|
2.9%
4/139
|
0.00%
0/138
|
0.00%
0/139
|
0.77%
1/130
|
0.00%
0/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Psychiatric disorders
Insomnia
|
0.72%
1/138
|
1.4%
2/139
|
0.00%
0/138
|
0.00%
0/139
|
0.00%
0/130
|
0.00%
0/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Nervous system disorders
Agitation
|
0.72%
1/138
|
0.00%
0/139
|
0.00%
0/138
|
0.00%
0/139
|
0.00%
0/130
|
0.00%
0/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Nervous system disorders
Restlessness
|
0.72%
1/138
|
0.00%
0/139
|
0.00%
0/138
|
0.00%
0/139
|
0.00%
0/130
|
0.00%
0/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Psychiatric disorders
Staring
|
0.00%
0/138
|
0.00%
0/139
|
0.72%
1/138
|
0.00%
0/139
|
0.00%
0/130
|
0.00%
0/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
21.0%
29/138
|
11.5%
16/139
|
0.72%
1/138
|
0.00%
0/139
|
7.7%
10/130
|
8.2%
10/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.72%
1/138
|
5.0%
7/139
|
0.00%
0/138
|
0.00%
0/139
|
0.77%
1/130
|
0.82%
1/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.72%
1/138
|
1.4%
2/139
|
0.72%
1/138
|
0.00%
0/139
|
0.77%
1/130
|
0.00%
0/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.72%
1/138
|
0.72%
1/139
|
0.00%
0/138
|
0.00%
0/139
|
0.00%
0/130
|
0.00%
0/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.72%
1/138
|
0.72%
1/139
|
0.00%
0/138
|
0.00%
0/139
|
0.00%
0/130
|
0.00%
0/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.72%
1/138
|
0.00%
0/139
|
0.00%
0/138
|
0.00%
0/139
|
0.00%
0/130
|
0.00%
0/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/138
|
0.72%
1/139
|
0.00%
0/138
|
0.00%
0/139
|
0.00%
0/130
|
0.00%
0/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Respiratory, thoracic and mediastinal disorders
Grunting
|
0.72%
1/138
|
0.00%
0/139
|
0.00%
0/138
|
0.00%
0/139
|
0.00%
0/130
|
0.00%
0/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/138
|
0.00%
0/139
|
0.00%
0/138
|
2.2%
3/139
|
0.00%
0/130
|
0.00%
0/122
|
0.00%
0/138
|
0.72%
1/139
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/138
|
0.00%
0/139
|
0.00%
0/138
|
0.00%
0/139
|
0.00%
0/130
|
0.82%
1/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Skin and subcutaneous tissue disorders
Eczema
|
8.0%
11/138
|
3.6%
5/139
|
0.72%
1/138
|
1.4%
2/139
|
0.77%
1/130
|
0.82%
1/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.2%
3/138
|
3.6%
5/139
|
0.00%
0/138
|
0.00%
0/139
|
0.00%
0/130
|
0.82%
1/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
1.4%
2/138
|
3.6%
5/139
|
0.00%
0/138
|
0.00%
0/139
|
0.77%
1/130
|
0.00%
0/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
1.4%
2/138
|
1.4%
2/139
|
0.00%
0/138
|
0.00%
0/139
|
0.00%
0/130
|
0.00%
0/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Skin and subcutaneous tissue disorders
Eczema infantile
|
0.72%
1/138
|
1.4%
2/139
|
0.00%
0/138
|
0.00%
0/139
|
0.00%
0/130
|
0.00%
0/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/138
|
1.4%
2/139
|
0.00%
0/138
|
0.00%
0/139
|
0.00%
0/130
|
0.00%
0/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.72%
1/138
|
0.72%
1/139
|
0.00%
0/138
|
0.00%
0/139
|
0.00%
0/130
|
0.00%
0/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.72%
1/138
|
0.00%
0/139
|
0.00%
0/138
|
0.00%
0/139
|
0.00%
0/130
|
0.00%
0/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Skin and subcutaneous tissue disorders
Heat rash
|
0.00%
0/138
|
0.72%
1/139
|
0.00%
0/138
|
0.00%
0/139
|
0.00%
0/130
|
0.00%
0/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/138
|
0.72%
1/139
|
0.00%
0/138
|
0.00%
0/139
|
0.00%
0/130
|
0.00%
0/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/138
|
0.72%
1/139
|
0.00%
0/138
|
0.00%
0/139
|
0.00%
0/130
|
0.00%
0/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.72%
1/138
|
0.00%
0/139
|
0.00%
0/138
|
0.00%
0/139
|
0.77%
1/130
|
0.00%
0/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.72%
1/138
|
0.00%
0/139
|
0.00%
0/138
|
0.00%
0/139
|
0.00%
0/130
|
0.00%
0/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Skin and subcutaneous tissue disorders
Umbilical erythema
|
0.72%
1/138
|
0.00%
0/139
|
0.00%
0/138
|
0.00%
0/139
|
0.00%
0/130
|
0.00%
0/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.00%
0/138
|
0.00%
0/139
|
0.72%
1/138
|
0.00%
0/139
|
0.00%
0/130
|
0.00%
0/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/138
|
0.00%
0/139
|
0.00%
0/138
|
0.00%
0/139
|
0.77%
1/130
|
0.00%
0/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Vascular disorders
Flushing
|
0.72%
1/138
|
0.72%
1/139
|
0.00%
0/138
|
0.00%
0/139
|
0.00%
0/130
|
0.00%
0/122
|
0.00%
0/138
|
0.00%
0/139
|
|
Skin and subcutaneous tissue disorders
Tenderness (Any)
|
42.1%
48/114
|
40.6%
39/96
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
Skin and subcutaneous tissue disorders
Tenderness (Significant)
|
4.1%
4/97
|
4.5%
4/89
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
Skin and subcutaneous tissue disorders
Induration (Any)
|
30.2%
32/106
|
34.4%
32/93
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
Skin and subcutaneous tissue disorders
Induration (Mild)
|
28.6%
30/105
|
29.0%
27/93
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
Skin and subcutaneous tissue disorders
Induration (Moderate)
|
8.2%
8/98
|
6.8%
6/88
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
Skin and subcutaneous tissue disorders
Induration (Severe)
|
1.0%
1/96
|
0.00%
0/88
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
Skin and subcutaneous tissue disorders
Erythema (Any)
|
39.3%
42/107
|
40.4%
40/99
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
Skin and subcutaneous tissue disorders
Erythema (Mild)
|
37.7%
40/106
|
37.4%
37/99
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
Skin and subcutaneous tissue disorders
Erythema (Moderate)
|
4.1%
4/98
|
3.4%
3/88
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
Skin and subcutaneous tissue disorders
Erythema (Severe)
|
2.1%
2/97
|
0.00%
0/88
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
General disorders
Fever ≥38°C but ≤39°C
|
3.1%
3/96
|
4.5%
4/88
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
General disorders
Fever >39°C but ≤40°C
|
0.00%
0/95
|
0.00%
0/88
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
General disorders
Fever >40°C
|
2.1%
2/96
|
0.00%
0/88
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
General disorders
Decreased appetite
|
35.6%
37/104
|
37.8%
37/98
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
General disorders
Increased sleep
|
51.8%
59/114
|
56.9%
62/109
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
General disorders
Decreased sleep
|
35.7%
35/98
|
38.0%
38/100
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER