Trial Outcomes & Findings for Study Evaluating Pneumococcal Vaccine in Healthy Infants (NCT NCT00205803)
NCT ID: NCT00205803
Last Updated: 2012-08-15
Results Overview
Local reaction events were collected using a paper worksheet. Tenderness was scaled as Any (tenderness present); Significant (Sig.) (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 centimeters \[cm\] to 2.0 cm); Moderate (Mod.)(2.5 to 7.0 cm); Severe (Sev.)(\> 7.0 cm). Participants may be represented in more than 1 category.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
249 participants
Primary outcome timeframe
Within 15 days after each dose
Results posted on
2012-08-15
Participant Flow
Participants were recruited in the United States from September 2004 to September 2005.
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 Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
|
7vPnC
Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
|
|---|---|---|
|
Infant Series
STARTED
|
122
|
127
|
|
Infant Series
Vaccinated Dose 1
|
121
|
126
|
|
Infant Series
Vaccinated Dose 2
|
115
|
122
|
|
Infant Series
Vaccinated Dose 3
|
110
|
118
|
|
Infant Series
COMPLETED
|
104
|
116
|
|
Infant Series
NOT COMPLETED
|
18
|
11
|
|
After Infant Series
STARTED
|
104
|
116
|
|
After Infant Series
COMPLETED
|
86
|
103
|
|
After Infant Series
NOT COMPLETED
|
18
|
13
|
|
Toddler Dose
STARTED
|
86
|
103
|
|
Toddler Dose
COMPLETED
|
84
|
100
|
|
Toddler Dose
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
| Measure |
13vPnC
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
|
7vPnC
Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
|
|---|---|---|
|
Infant Series
Lost to Follow-up
|
10
|
4
|
|
Infant Series
Withdrawal by Subject
|
2
|
5
|
|
Infant Series
Physician Decision
|
3
|
1
|
|
Infant Series
Protocol Violation
|
1
|
0
|
|
Infant Series
Lost Kaiser coverage
|
0
|
1
|
|
Infant Series
Non-compliant
|
1
|
0
|
|
Infant Series
Sponsor request
|
1
|
0
|
|
After Infant Series
Adverse Event
|
1
|
1
|
|
After Infant Series
Protocol Violation
|
1
|
1
|
|
After Infant Series
Lost to Follow-up
|
2
|
1
|
|
After Infant Series
Physician Decision
|
3
|
2
|
|
After Infant Series
Withdrawal by Subject
|
1
|
4
|
|
After Infant Series
Other
|
10
|
4
|
|
Toddler Dose
Lost to Follow-up
|
2
|
3
|
Baseline Characteristics
Study Evaluating Pneumococcal Vaccine in Healthy Infants
Baseline characteristics by cohort
| Measure |
13vPnC
n=121 Participants
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
|
7vPnC
n=126 Participants
Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
|
Total
n=247 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
9.2 weeks
STANDARD_DEVIATION 1.4 • n=5 Participants
|
9.1 weeks
STANDARD_DEVIATION 1.2 • n=7 Participants
|
9.2 weeks
STANDARD_DEVIATION 1.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
58 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
117 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
63 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
130 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Within 15 days after each dosePopulation: The safety population included all participants who received at least 1 dose of vaccine;(n)=number of participants with known values.
Local reaction events were collected using a paper worksheet. Tenderness was scaled as Any (tenderness present); Significant (Sig.) (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 centimeters \[cm\] to 2.0 cm); Moderate (Mod.)(2.5 to 7.0 cm); Severe (Sev.)(\> 7.0 cm). Participants may be represented in more than 1 category.
Outcome measures
| Measure |
13vPnC Dose 1
n=121 Participants
Participants received one single 0.5mL dose of 13vPnC coadministered with Pediarix and ActHIB at 2 months of age (infant series Dose 1).
|
7vPnc Dose 1
n=126 Participants
Participants received one single 0.5mL dose of 7vPnC coadministered with Pediarix and ActHIB at 2 months of age (infant series Dose 1).
|
13vPnC Dose 2
n=115 Participants
Participants received one single 0.5mL dose of 13vPnC coadministered with Pediarix and ActHIB at 4 months of age (infant series Dose 2).
|
7vPnC Dose 2
n=122 Participants
Participants received one single 0.5mL dose of 7vPnC coadministered with Pediarix and ActHIB at 4 months of age (infant series Dose 2).
|
13vPnC Dose 3
n=110 Participants
Participants received one single 0.5mL dose of 13vPnC coadministered with Pediarix and ActHIB at 6 months of age (infant series Dose 3).
|
7vPnC Dose 3
n=118 Participants
Participants received one single 0.5mL dose of 7vPnC coadministered with Pediarix and ActHIB at 6 months of age (infant series Dose 3).
|
13vPnC Toddler Dose
n=86 Participants
Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12 to 15 months of age (toddler dose).
|
7vPnC Toddler Dose
n=103 Participants
Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12 to 15 months of age (toddler dose).
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Reporting Pre-Specified Local Reactions
Tenderness-Any (n=119,124,110,118,107,117,85,101)
|
34.5 percentage of participants
|
43.5 percentage of participants
|
28.2 percentage of participants
|
36.4 percentage of participants
|
24.3 percentage of participants
|
25.6 percentage of participants
|
22.4 percentage of participants
|
29.7 percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions
Tenderness-Sig. (n=119,124,110,118,107,117,85,101)
|
8.4 percentage of participants
|
5.6 percentage of participants
|
1.8 percentage of participants
|
8.5 percentage of participants
|
4.7 percentage of participants
|
6.0 percentage of participants
|
2.4 percentage of participants
|
4.0 percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions
Induration-Any (n=119,124,110,118,107,117,85,100)
|
21.8 percentage of participants
|
19.4 percentage of participants
|
16.4 percentage of participants
|
19.5 percentage of participants
|
16.8 percentage of participants
|
18.8 percentage of participants
|
18.8 percentage of participants
|
17.0 percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions
Induration-Mild (n=119,123,110,117,107,116,85,100)
|
20.2 percentage of participants
|
17.9 percentage of participants
|
16.4 percentage of participants
|
17.1 percentage of participants
|
16.8 percentage of participants
|
17.2 percentage of participants
|
18.8 percentage of participants
|
17.0 percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions
Induration-Mod. (n=119,123,110,117,107,116,85,100)
|
3.4 percentage of participants
|
2.4 percentage of participants
|
3.6 percentage of participants
|
3.4 percentage of participants
|
0.0 percentage of participants
|
4.3 percentage of participants
|
2.4 percentage of participants
|
3.0 percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions
Induration-Sev. (n=119,123,110,117,107,116,85,100)
|
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
Erythema-Any (n=119,124,111,118,107,117, 85,100)
|
21.0 percentage of participants
|
19.4 percentage of participants
|
16.2 percentage of participants
|
17.8 percentage of participants
|
17.8 percentage of participants
|
19.7 percentage of participants
|
24.7 percentage of participants
|
19.0 percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions
Erythema-Mild (n=119,124,110,117,106,116,85,99)
|
20.2 percentage of participants
|
19.4 percentage of participants
|
13.6 percentage of participants
|
17.1 percentage of participants
|
16.0 percentage of participants
|
18.1 percentage of participants
|
24.7 percentage of participants
|
16.2 percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions
Erythema-Mod. (n=119,124,108,117,106,116,85,99)
|
2.5 percentage of participants
|
0.0 percentage of participants
|
2.8 percentage of participants
|
0.0 percentage of participants
|
0.9 percentage of participants
|
2.6 percentage of participants
|
3.5 percentage of participants
|
5.1 percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions
Erythema-Severe (n=119,124,108,117,106,116,85,99)
|
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
|
PRIMARY outcome
Timeframe: Within 15 days after each dosePopulation: The safety population included all participants who received at least 1 dose of vaccine; (n)=number of participants with known values.
Systemic events (fever \[Fv\] ≥ 38 degrees Celsius \[C\] but ≤ 39 C, fever \>39 C but ≤ 40 C, fever \> 40 C, decreased (decr.) appetite, irritability, increased sleep, decreased sleep, use of medication (Med.)to prevent symptoms (sx), and use of medication to treat symptoms) were reported using a paper worksheet. Participants may be represented in more than 1 category.
Outcome measures
| Measure |
13vPnC Dose 1
n=121 Participants
Participants received one single 0.5mL dose of 13vPnC coadministered with Pediarix and ActHIB at 2 months of age (infant series Dose 1).
|
7vPnc Dose 1
n=126 Participants
Participants received one single 0.5mL dose of 7vPnC coadministered with Pediarix and ActHIB at 2 months of age (infant series Dose 1).
|
13vPnC Dose 2
n=115 Participants
Participants received one single 0.5mL dose of 13vPnC coadministered with Pediarix and ActHIB at 4 months of age (infant series Dose 2).
|
7vPnC Dose 2
n=122 Participants
Participants received one single 0.5mL dose of 7vPnC coadministered with Pediarix and ActHIB at 4 months of age (infant series Dose 2).
|
13vPnC Dose 3
n=110 Participants
Participants received one single 0.5mL dose of 13vPnC coadministered with Pediarix and ActHIB at 6 months of age (infant series Dose 3).
|
7vPnC Dose 3
n=118 Participants
Participants received one single 0.5mL dose of 7vPnC coadministered with Pediarix and ActHIB at 6 months of age (infant series Dose 3).
|
13vPnC Toddler Dose
n=86 Participants
Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12 to 15 months of age (toddler dose).
|
7vPnC Toddler Dose
n=103 Participants
Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12 to 15 months of age (toddler dose).
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Reporting Pre-Specified Systemic Events
Fv ≥38°C but≤39°C(n=114,121,102,114,100,113,78,94)
|
16.7 percentage of participants
|
16.5 percentage of participants
|
21.6 percentage of participants
|
24.6 percentage of participants
|
20.0 percentage of participants
|
20.4 percentage of participants
|
14.1 percentage of participants
|
12.8 percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events
Fv >40°C (n=113,121,102,113,100,113,76,94)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events
Decr. Appetite (n=118,124,110,118,107,117,85,101)
|
30.5 percentage of participants
|
31.5 percentage of participants
|
22.7 percentage of participants
|
22.9 percentage of participants
|
27.1 percentage of participants
|
30.8 percentage of participants
|
22.4 percentage of participants
|
21.8 percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events
Decr. Sleep (n=118,124,110,118,107,117,84,101)
|
18.6 percentage of participants
|
17.7 percentage of participants
|
24.5 percentage of participants
|
19.5 percentage of participants
|
21.5 percentage of participants
|
18.8 percentage of participants
|
13.1 percentage of participants
|
14.9 percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events
Fv >39°C but≤40°C(n=113,121,102,113,101,113,77,94)
|
2.7 percentage of participants
|
0.8 percentage of participants
|
3.9 percentage of participants
|
3.5 percentage of participants
|
2.0 percentage of participants
|
0.9 percentage of participants
|
2.6 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events
Increased Sleep (n=119,124,111,118,107,117,86,101)
|
56.3 percentage of participants
|
54.0 percentage of participants
|
42.3 percentage of participants
|
46.6 percentage of participants
|
34.6 percentage of participants
|
41.0 percentage of participants
|
27.9 percentage of participants
|
43.6 percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events
Irritability (n=118,124,110,118,107,117,85,101)
|
66.9 percentage of participants
|
71.0 percentage of participants
|
62.7 percentage of participants
|
56.8 percentage of participants
|
51.4 percentage of participants
|
53.8 percentage of participants
|
38.8 percentage of participants
|
47.5 percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events
Med.-Prevent Sx (n=95,101,86,96,83,93,85,102)
|
29.5 percentage of participants
|
33.7 percentage of participants
|
34.9 percentage of participants
|
32.3 percentage of participants
|
36.1 percentage of participants
|
43.0 percentage of participants
|
17.6 percentage of participants
|
35.3 percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events
Med.-Treat Symptoms (n=94,101,86,96,84,94,85,101)
|
44.7 percentage of participants
|
34.7 percentage of participants
|
48.8 percentage of participants
|
50.0 percentage of participants
|
42.9 percentage of participants
|
47.9 percentage of participants
|
29.4 percentage of participants
|
27.7 percentage of participants
|
PRIMARY outcome
Timeframe: one month after 3-dose infant series (at 7 months of age)Population: Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n)=number of participants with a determinate postinfant series IgG antibody concentration to the given serotype.
Percentage of participants achieving World Health Organization (WHO) predefined antibody threshold ≥0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.
Outcome measures
| Measure |
13vPnC Dose 1
n=94 Participants
Participants received one single 0.5mL dose of 13vPnC coadministered with Pediarix and ActHIB at 2 months of age (infant series Dose 1).
|
7vPnc Dose 1
n=108 Participants
Participants received one single 0.5mL dose of 7vPnC coadministered with Pediarix and ActHIB at 2 months of age (infant series Dose 1).
|
13vPnC Dose 2
Participants received one single 0.5mL dose of 13vPnC coadministered with Pediarix and ActHIB at 4 months of age (infant series Dose 2).
|
7vPnC Dose 2
Participants received one single 0.5mL dose of 7vPnC coadministered with Pediarix and ActHIB at 4 months of age (infant series Dose 2).
|
13vPnC Dose 3
Participants received one single 0.5mL dose of 13vPnC coadministered with Pediarix and ActHIB at 6 months of age (infant series Dose 3).
|
7vPnC Dose 3
Participants received one single 0.5mL dose of 7vPnC coadministered with Pediarix and ActHIB at 6 months of age (infant series Dose 3).
|
13vPnC Toddler Dose
Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12 to 15 months of age (toddler dose).
|
7vPnC Toddler Dose
Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12 to 15 months of age (toddler dose).
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Additional Serotypes - Serotype 6A (n=93,106)
|
96.77 percentage of participants
Interval 90.86 to 99.33
|
33.96 percentage of participants
Interval 25.04 to 43.8
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Additional Serotypes - Serotype 7F (n=94,105)
|
98.94 percentage of participants
Interval 94.21 to 99.97
|
6.67 percentage of participants
Interval 2.72 to 13.25
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Additional Serotypes - Serotype 5 (n=93,107)
|
100.00 percentage of participants
Interval 96.11 to 100.0
|
42.06 percentage of participants
Interval 32.58 to 51.99
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Common Serotypes - Serotype 4 (n=94,107)
|
96.81 percentage of participants
Interval 90.96 to 99.34
|
99.07 percentage of participants
Interval 94.9 to 99.98
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Common Serotypes - Serotype 6B (n=94,107)
|
88.30 percentage of participants
Interval 80.03 to 94.01
|
88.79 percentage of participants
Interval 81.23 to 94.07
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Common Serotypes - Serotype 9V (n=94,108)
|
96.81 percentage of participants
Interval 90.96 to 99.34
|
99.07 percentage of participants
Interval 94.95 to 99.98
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Common Serotypes - Serotype 14 (n=94,107)
|
97.87 percentage of participants
Interval 92.52 to 99.74
|
97.20 percentage of participants
Interval 92.02 to 99.42
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Common Serotypes - Serotype 18C (n=94,106)
|
96.81 percentage of participants
Interval 90.96 to 99.34
|
99.06 percentage of participants
Interval 94.86 to 99.98
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Common Serotypes - Serotype 19F (n=94,106)
|
97.87 percentage of participants
Interval 92.52 to 99.74
|
97.17 percentage of participants
Interval 91.95 to 99.41
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Common Serotypes - Serotype 23F (n=94,108)
|
94.68 percentage of participants
Interval 88.02 to 98.25
|
95.37 percentage of participants
Interval 89.53 to 98.48
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Additional Serotypes - Serotype 1 (n=94,108)
|
97.87 percentage of participants
Interval 92.52 to 99.74
|
25.00 percentage of participants
Interval 17.17 to 34.25
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Additional Serotypes - Serotype 3 (n=94,107)
|
98.94 percentage of participants
Interval 94.21 to 99.97
|
14.02 percentage of participants
Interval 8.06 to 22.07
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Additional Serotypes - Serotype 19A (n=94,107)
|
100.00 percentage of participants
Interval 96.15 to 100.0
|
94.39 percentage of participants
Interval 88.19 to 97.91
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: One month after the toddler dose (at 13 to 16 months of age)Population: The All-Available Toddler Immunogenicity population consisted of eligible participants who had at least 1 valid and determinate assay result related to the proposed analysis; (n)=number of participants with a determinate posttoddler dose 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. Exact 2-sided CI based on the observed proportion of participants.
Outcome measures
| Measure |
13vPnC Dose 1
n=85 Participants
Participants received one single 0.5mL dose of 13vPnC coadministered with Pediarix and ActHIB at 2 months of age (infant series Dose 1).
|
7vPnc Dose 1
n=102 Participants
Participants received one single 0.5mL dose of 7vPnC coadministered with Pediarix and ActHIB at 2 months of age (infant series Dose 1).
|
13vPnC Dose 2
Participants received one single 0.5mL dose of 13vPnC coadministered with Pediarix and ActHIB at 4 months of age (infant series Dose 2).
|
7vPnC Dose 2
Participants received one single 0.5mL dose of 7vPnC coadministered with Pediarix and ActHIB at 4 months of age (infant series Dose 2).
|
13vPnC Dose 3
Participants received one single 0.5mL dose of 13vPnC coadministered with Pediarix and ActHIB at 6 months of age (infant series Dose 3).
|
7vPnC Dose 3
Participants received one single 0.5mL dose of 7vPnC coadministered with Pediarix and ActHIB at 6 months of age (infant series Dose 3).
|
13vPnC Toddler Dose
Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12 to 15 months of age (toddler dose).
|
7vPnC Toddler Dose
Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12 to 15 months of age (toddler dose).
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose
Additional Serotypes - Serotype 3 (n=78,92)
|
92.3 percentage of participants
Interval 84.0 to 97.1
|
8.7 percentage of participants
Interval 3.8 to 16.4
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose
Additional Serotypes - Serotype 5 (n=78,78)
|
100.0 percentage of participants
Interval 95.4 to 100.0
|
70.5 percentage of participants
Interval 59.1 to 80.3
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose
Additional Serotypes - Serotype 6A (n=78,92)
|
100.0 percentage of participants
Interval 95.4 to 100.0
|
88.0 percentage of participants
Interval 79.6 to 93.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose
Additional Serotypes - Serotype 7F (n=78,85)
|
100.0 percentage of participants
Interval 95.4 to 100.0
|
5.9 percentage of participants
Interval 1.9 to 13.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose
Common Serotypes - Serotype 4 (n=78,94)
|
97.4 percentage of participants
Interval 91.0 to 99.7
|
98.9 percentage of participants
Interval 94.2 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose
Common Serotypes - Serotype 6B (n=78,93)
|
100.0 percentage of participants
Interval 95.4 to 100.0
|
100.0 percentage of participants
Interval 96.1 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose
Common Serotypes - Serotype 9V (n=78,94)
|
98.7 percentage of participants
Interval 93.1 to 100.0
|
100.0 percentage of participants
Interval 96.2 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose
Common Serotypes - Serotype 14 (n=78,93)
|
100.0 percentage of participants
Interval 95.4 to 100.0
|
100.0 percentage of participants
Interval 96.1 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose
Common Serotypes - Serotype 18C (n=78,94)
|
100.0 percentage of participants
Interval 95.4 to 100.0
|
100.0 percentage of participants
Interval 96.2 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose
Common Serotypes - Serotype 19F (n=78,93)
|
100.0 percentage of participants
Interval 95.4 to 100.0
|
100.0 percentage of participants
Interval 96.1 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose
Common Serotypes - Serotype 23F (n=78,93)
|
100.0 percentage of participants
Interval 95.4 to 100.0
|
97.8 percentage of participants
Interval 92.4 to 99.7
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose
Additional Serotypes - Serotype 1 (n=78,91)
|
100.00 percentage of participants
Interval 95.4 to 100.0
|
2.2 percentage of participants
Interval 0.3 to 7.7
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose
Additional Serotypes - Serotype 19A (n=78,93)
|
100.0 percentage of participants
Interval 95.4 to 100.0
|
100.0 percentage of participants
Interval 96.1 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: One month after 3-dose infant series (at 7 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 geometric mean concentration (GMC) as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC ratios (13vPnC/7vPnC) and corresponding 2-sided 95% CI were evaluated.
Outcome measures
| Measure |
13vPnC Dose 1
n=94 Participants
Participants received one single 0.5mL dose of 13vPnC coadministered with Pediarix and ActHIB at 2 months of age (infant series Dose 1).
|
7vPnc Dose 1
n=108 Participants
Participants received one single 0.5mL dose of 7vPnC coadministered with Pediarix and ActHIB at 2 months of age (infant series Dose 1).
|
13vPnC Dose 2
Participants received one single 0.5mL dose of 13vPnC coadministered with Pediarix and ActHIB at 4 months of age (infant series Dose 2).
|
7vPnC Dose 2
Participants received one single 0.5mL dose of 7vPnC coadministered with Pediarix and ActHIB at 4 months of age (infant series Dose 2).
|
13vPnC Dose 3
Participants received one single 0.5mL dose of 13vPnC coadministered with Pediarix and ActHIB at 6 months of age (infant series Dose 3).
|
7vPnC Dose 3
Participants received one single 0.5mL dose of 7vPnC coadministered with Pediarix and ActHIB at 6 months of age (infant series Dose 3).
|
13vPnC Toddler Dose
Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12 to 15 months of age (toddler dose).
|
7vPnC Toddler Dose
Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12 to 15 months of age (toddler dose).
|
|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Common Serotypes - Serotype 9V (n=94,108)
|
1.52 μg/mL
Interval 1.29 to 1.78
|
1.78 μg/mL
Interval 1.55 to 2.05
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Common Serotypes - Serotype 14 (n=94,107)
|
4.24 μg/mL
Interval 3.44 to 5.23
|
5.19 μg/mL
Interval 4.13 to 6.52
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Common Serotypes - Serotype 18C (n=94,106)
|
1.53 μg/mL
Interval 1.3 to 1.8
|
2.46 μg/mL
Interval 2.08 to 2.91
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Common Serotypes - Serotype 19F (n=94,106)
|
2.21 μg/mL
Interval 1.87 to 2.61
|
2.58 μg/mL
Interval 2.17 to 3.08
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Common Serotypes - Serotype 23F (n=94,108)
|
1.39 μg/mL
Interval 1.15 to 1.67
|
1.81 μg/mL
Interval 1.51 to 2.19
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Additional Serotypes - Serotype 1 (n=94,108)
|
2.57 μg/mL
Interval 2.14 to 3.08
|
0.06 μg/mL
Interval 0.05 to 0.09
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Additional Serotypes - Serotype 19A (n=94,107)
|
1.93 μg/mL
Interval 1.64 to 2.27
|
1.12 μg/mL
Interval 0.96 to 1.32
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Common Serotypes - Serotype 4 (n=94,107)
|
1.81 μg/mL
Interval 1.54 to 2.13
|
2.40 μg/mL
Interval 2.01 to 2.87
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Common Serotypes - Serotype 6B (n=94,107)
|
2.74 μg/mL
Interval 2.02 to 3.71
|
2.86 μg/mL
Interval 2.09 to 3.91
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Additional Serotypes - Serotype 3 (n=94,107)
|
1.40 μg/mL
Interval 1.2 to 1.62
|
0.09 μg/mL
Interval 0.07 to 0.11
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Additional Serotypes - Serotype 5 (n=93,107)
|
2.41 μg/mL
Interval 2.07 to 2.8
|
0.28 μg/mL
Interval 0.22 to 0.34
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Additional Serotypes - Serotype 6A (n=93,106)
|
2.36 μg/mL
Interval 1.89 to 2.94
|
0.25 μg/mL
Interval 0.2 to 0.3
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Additional Serotypes - Serotype 7F (n=94,105)
|
1.85 μg/mL
Interval 1.62 to 2.11
|
0.07 μg/mL
Interval 0.06 to 0.08
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Immediately before (12 to 15 months of age) and one month after the toddler dose (13 to 16 months of age)Population: All-Available Toddler Immunogenicity population consisted of eligible participants who had at least 1 valid and determinate assay result related to proposed analysis;(n)= number of participants with a determinate antibody concentration for the specified serotype.
Antibody geometric mean concentration (GMC) as measured by ELISA with their corresponding 95% CI immediately before and after the toddler dose for 7 common pneumococcal serotypes (Serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
Outcome measures
| Measure |
13vPnC Dose 1
n=85 Participants
Participants received one single 0.5mL dose of 13vPnC coadministered with Pediarix and ActHIB at 2 months of age (infant series Dose 1).
|
7vPnc Dose 1
n=102 Participants
Participants received one single 0.5mL dose of 7vPnC coadministered with Pediarix and ActHIB at 2 months of age (infant series Dose 1).
|
13vPnC Dose 2
n=85 Participants
Participants received one single 0.5mL dose of 13vPnC coadministered with Pediarix and ActHIB at 4 months of age (infant series Dose 2).
|
7vPnC Dose 2
n=102 Participants
Participants received one single 0.5mL dose of 7vPnC coadministered with Pediarix and ActHIB at 4 months of age (infant series Dose 2).
|
13vPnC Dose 3
Participants received one single 0.5mL dose of 13vPnC coadministered with Pediarix and ActHIB at 6 months of age (infant series Dose 3).
|
7vPnC Dose 3
Participants received one single 0.5mL dose of 7vPnC coadministered with Pediarix and ActHIB at 6 months of age (infant series Dose 3).
|
13vPnC Toddler Dose
Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12 to 15 months of age (toddler dose).
|
7vPnC Toddler Dose
Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12 to 15 months of age (toddler dose).
|
|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose
Common Serotypes-Serotype 6B (n=82,98,78,93)
|
0.84 μg/mL
Interval 0.69 to 1.03
|
0.95 μg/mL
Interval 0.77 to 1.18
|
11.03 μg/mL
Interval 8.78 to 13.86
|
11.85 μg/mL
Interval 9.63 to 14.56
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose
Common Serotypes-Serotype 9V (n=83,100,78,94)
|
0.43 μg/mL
Interval 0.37 to 0.51
|
0.43 μg/mL
Interval 0.37 to 0.5
|
2.55 μg/mL
Interval 2.15 to 3.02
|
2.75 μg/mL
Interval 2.37 to 3.18
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose
Common Serotypes-Serotype 18C (n=83,100,78,94)
|
0.25 μg/mL
Interval 0.22 to 0.3
|
0.40 μg/mL
Interval 0.34 to 0.46
|
2.57 μg/mL
Interval 2.08 to 3.18
|
4.08 μg/mL
Interval 3.42 to 4.87
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose
Common Serotypes-Serotype 19F (n=82,100,78,93)
|
0.81 μg/mL
Interval 0.66 to 1.0
|
0.60 μg/mL
Interval 0.49 to 0.72
|
6.34 μg/mL
Interval 5.06 to 7.94
|
3.97 μg/mL
Interval 3.26 to 4.85
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose
Common Serotypes-Serotype 23F (n=83,100,78,93)
|
0.29 μg/mL
Interval 0.24 to 0.36
|
0.38 μg/mL
Interval 0.31 to 0.47
|
3.36 μg/mL
Interval 2.7 to 4.18
|
4.79 μg/mL
Interval 3.86 to 5.94
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose
Additional Serotypes-Serotype 5 (n=83,92,78,78)
|
1.01 μg/mL
Interval 0.87 to 1.18
|
0.40 μg/mL
Interval 0.31 to 0.5
|
3.92 μg/mL
Interval 3.27 to 4.69
|
0.56 μg/mL
Interval 0.45 to 0.7
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose
Common Serotypes-Serotype 4 (n=83,100,78,94)
|
0.33 μg/mL
Interval 0.28 to 0.4
|
0.48 μg/mL
Interval 0.41 to 0.56
|
2.86 μg/mL
Interval 2.31 to 3.55
|
4.09 μg/mL
Interval 3.34 to 5.0
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose
Common Serotypes-Serotype 14 (n=83,100,78,93)
|
1.59 μg/mL
Interval 1.27 to 2.0
|
2.00 μg/mL
Interval 1.66 to 2.41
|
7.68 μg/mL
Interval 6.08 to 9.7
|
10.24 μg/mL
Interval 8.23 to 12.74
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose
Additional Serotypes-Serotype 1 (n=83,90,78,91)
|
0.68 μg/mL
Interval 0.56 to 0.82
|
0.04 μg/mL
Interval 0.03 to 0.04
|
3.44 μg/mL
Interval 2.79 to 4.23
|
0.03 μg/mL
Interval 0.03 to 0.04
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose
Additional Serotypes-Serotype 3 (n=83,98,78,92)
|
0.27 μg/mL
Interval 0.23 to 0.32
|
0.09 μg/mL
Interval 0.07 to 0.12
|
1.11 μg/mL
Interval 0.94 to 1.33
|
0.10 μg/mL
Interval 0.08 to 0.12
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose
Additional Serotypes-Serotype 6A (n=82,96,78,92)
|
0.81 μg/mL
Interval 0.68 to 0.96
|
0.27 μg/mL
Interval 0.22 to 0.33
|
8.06 μg/mL
Interval 6.6 to 9.85
|
1.68 μg/mL
Interval 1.27 to 2.21
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose
Additional Serotypes-Serotype 7F (n=83,91,78,85)
|
0.58 μg/mL
Interval 0.5 to 0.67
|
0.04 μg/mL
Interval 0.03 to 0.05
|
2.67 μg/mL
Interval 2.26 to 3.16
|
0.05 μg/mL
Interval 0.04 to 0.06
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose
Additional Serotypes-Serotype19A (n=83,100,78,93)
|
0.85 μg/mL
Interval 0.67 to 1.09
|
0.64 μg/mL
Interval 0.52 to 0.79
|
5.60 μg/mL
Interval 4.6 to 6.83
|
2.82 μg/mL
Interval 2.32 to 3.41
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: One month after the infant series (7 months of age)Population: Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations;(n)=number of participants with a determinate postinfant series antibody level to the given concomitant vaccine component.
Percentage of participants achieving predefined antibody threshold levels for Haemophilus Influenzae Type b (Hib) polyribosylribitol phosphate (PRP), Diphtheria Toxoid, Polio (Types 1, 2, and 3), Pertussis (filamentous hemagglutinin \[FHA\], Pertussis Toxoid, and Pertactin), Tetanus, and Hepatitis B with the corresponding 95% CI for each concomitant antigen are presented.
Outcome measures
| Measure |
13vPnC Dose 1
n=94 Participants
Participants received one single 0.5mL dose of 13vPnC coadministered with Pediarix and ActHIB at 2 months of age (infant series Dose 1).
|
7vPnc Dose 1
n=108 Participants
Participants received one single 0.5mL dose of 7vPnC coadministered with Pediarix and ActHIB at 2 months of age (infant series Dose 1).
|
13vPnC Dose 2
Participants received one single 0.5mL dose of 13vPnC coadministered with Pediarix and ActHIB at 4 months of age (infant series Dose 2).
|
7vPnC Dose 2
Participants received one single 0.5mL dose of 7vPnC coadministered with Pediarix and ActHIB at 4 months of age (infant series Dose 2).
|
13vPnC Dose 3
Participants received one single 0.5mL dose of 13vPnC coadministered with Pediarix and ActHIB at 6 months of age (infant series Dose 3).
|
7vPnC Dose 3
Participants received one single 0.5mL dose of 7vPnC coadministered with Pediarix and ActHIB at 6 months of age (infant series Dose 3).
|
13vPnC Toddler Dose
Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12 to 15 months of age (toddler dose).
|
7vPnC Toddler Dose
Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12 to 15 months of age (toddler dose).
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, Polio, Pertussis, Tetanus, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series
Hib (PRP) 1.0 μg/mL (n=84,87)
|
70.24 Percentage of participants
Interval 59.27 to 79.73
|
63.22 Percentage of participants
Interval 52.2 to 73.31
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, Polio, Pertussis, Tetanus, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series
Polio Type 3 (antibody threshold ≥1:8) (n=61,63)
|
98.36 Percentage of participants
Interval 91.2 to 99.96
|
100.00 Percentage of participants
Interval 94.31 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, Polio, Pertussis, Tetanus, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series
Pertussis - Pertussis Toxoid 43.00 EU/mL (n=65,68)
|
89.23 Percentage of participants
Interval 79.06 to 95.56
|
95.59 Percentage of participants
Interval 87.64 to 99.08
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, Polio, Pertussis, Tetanus, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series
Pertussis - FHA 82.00 EU/MI (n=65,68)
|
93.85 Percentage of participants
Interval 84.99 to 98.3
|
95.59 Percentage of participants
Interval 87.64 to 99.08
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, Polio, Pertussis, Tetanus, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series
Pertussis - Pertactin 18.00 EU/mL (n=65,68)
|
96.92 Percentage of participants
Interval 89.32 to 99.63
|
95.59 Percentage of participants
Interval 87.64 to 99.08
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, Polio, Pertussis, Tetanus, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series
Hib (PRP) 0.15 μg/mL (n=84,87)
|
89.29 Percentage of participants
Interval 80.63 to 94.98
|
86.21 Percentage of participants
Interval 77.15 to 92.66
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, Polio, Pertussis, Tetanus, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series
Diphtheria 0.01 IU/mL (n=38,48)
|
100.00 Percentage of participants
Interval 90.75 to 100.0
|
100.00 Percentage of participants
Interval 92.6 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, Polio, Pertussis, Tetanus, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series
Diphtheria 0.1 IU/mL (n=38,48)
|
100.00 Percentage of participants
Interval 90.75 to 100.0
|
100.00 Percentage of participants
Interval 92.6 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, Polio, Pertussis, Tetanus, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series
Tetanus 0.01 IU/mL (n=38,48)
|
100.00 Percentage of participants
Interval 90.75 to 100.0
|
100.00 Percentage of participants
Interval 92.6 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, Polio, Pertussis, Tetanus, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series
Tetanus 0.1 IU/mL (n=38,48)
|
100.00 Percentage of participants
Interval 90.75 to 100.0
|
100.00 Percentage of participants
Interval 92.6 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, Polio, Pertussis, Tetanus, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series
Polio Type 1 (antibody threshold ≥1:8) (n=61,64)
|
100.00 Percentage of participants
Interval 94.13 to 100.0
|
100.00 Percentage of participants
Interval 94.4 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, Polio, Pertussis, Tetanus, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series
Polio Type 2 (antibody threshold ≥1:8) (n=61,64)
|
98.36 Percentage of participants
Interval 91.2 to 99.96
|
100.00 Percentage of participants
Interval 9.4 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, Polio, Pertussis, Tetanus, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series
Hepatitis b 10 mIU/mL (n=38,48)
|
100.00 Percentage of participants
Interval 90.75 to 100.0
|
100.00 Percentage of participants
Interval 92.6 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: one month after the infant series (7 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 concomitant vaccine component.
Outcome measures
| Measure |
13vPnC Dose 1
n=84 Participants
Participants received one single 0.5mL dose of 13vPnC coadministered with Pediarix and ActHIB at 2 months of age (infant series Dose 1).
|
7vPnc Dose 1
n=87 Participants
Participants received one single 0.5mL dose of 7vPnC coadministered with Pediarix and ActHIB at 2 months of age (infant series Dose 1).
|
13vPnC Dose 2
Participants received one single 0.5mL dose of 13vPnC coadministered with Pediarix and ActHIB at 4 months of age (infant series Dose 2).
|
7vPnC Dose 2
Participants received one single 0.5mL dose of 7vPnC coadministered with Pediarix and ActHIB at 4 months of age (infant series Dose 2).
|
13vPnC Dose 3
Participants received one single 0.5mL dose of 13vPnC coadministered with Pediarix and ActHIB at 6 months of age (infant series Dose 3).
|
7vPnC Dose 3
Participants received one single 0.5mL dose of 7vPnC coadministered with Pediarix and ActHIB at 6 months of age (infant series Dose 3).
|
13vPnC Toddler Dose
Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12 to 15 months of age (toddler dose).
|
7vPnC Toddler Dose
Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12 to 15 months of age (toddler dose).
|
|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Antibody Concentration of Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the Infant Series
|
1.99 μg/mL
Interval 1.34 to 2.97
|
1.64 μg/mL
Interval 1.09 to 2.47
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: one month after the infant series (7 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 concomitant vaccine component.
GMCs of anti-hepatitis B surface antigen (HBsAg) using a Food and Drug Administration (FDA) approved in vitro diagnostic kit are presented.
Outcome measures
| Measure |
13vPnC Dose 1
n=38 Participants
Participants received one single 0.5mL dose of 13vPnC coadministered with Pediarix and ActHIB at 2 months of age (infant series Dose 1).
|
7vPnc Dose 1
n=48 Participants
Participants received one single 0.5mL dose of 7vPnC coadministered with Pediarix and ActHIB at 2 months of age (infant series Dose 1).
|
13vPnC Dose 2
Participants received one single 0.5mL dose of 13vPnC coadministered with Pediarix and ActHIB at 4 months of age (infant series Dose 2).
|
7vPnC Dose 2
Participants received one single 0.5mL dose of 7vPnC coadministered with Pediarix and ActHIB at 4 months of age (infant series Dose 2).
|
13vPnC Dose 3
Participants received one single 0.5mL dose of 13vPnC coadministered with Pediarix and ActHIB at 6 months of age (infant series Dose 3).
|
7vPnC Dose 3
Participants received one single 0.5mL dose of 7vPnC coadministered with Pediarix and ActHIB at 6 months of age (infant series Dose 3).
|
13vPnC Toddler Dose
Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12 to 15 months of age (toddler dose).
|
7vPnC Toddler Dose
Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12 to 15 months of age (toddler dose).
|
|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Antibody Concentration of Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series
|
1257.74 milli International Units (mIU)/mL
Interval 904.77 to 1748.42
|
1300.01 milli International Units (mIU)/mL
Interval 976.91 to 1729.99
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: one month after the infant series (7 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 concomitant vaccine component.
Outcome measures
| Measure |
13vPnC Dose 1
n=38 Participants
Participants received one single 0.5mL dose of 13vPnC coadministered with Pediarix and ActHIB at 2 months of age (infant series Dose 1).
|
7vPnc Dose 1
n=48 Participants
Participants received one single 0.5mL dose of 7vPnC coadministered with Pediarix and ActHIB at 2 months of age (infant series Dose 1).
|
13vPnC Dose 2
Participants received one single 0.5mL dose of 13vPnC coadministered with Pediarix and ActHIB at 4 months of age (infant series Dose 2).
|
7vPnC Dose 2
Participants received one single 0.5mL dose of 7vPnC coadministered with Pediarix and ActHIB at 4 months of age (infant series Dose 2).
|
13vPnC Dose 3
Participants received one single 0.5mL dose of 13vPnC coadministered with Pediarix and ActHIB at 6 months of age (infant series Dose 3).
|
7vPnC Dose 3
Participants received one single 0.5mL dose of 7vPnC coadministered with Pediarix and ActHIB at 6 months of age (infant series Dose 3).
|
13vPnC Toddler Dose
Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12 to 15 months of age (toddler dose).
|
7vPnC Toddler Dose
Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12 to 15 months of age (toddler dose).
|
|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Antibody Concentration Diphtheria Toxoid and Anti-Tetanus Toxoid in 13vPnC Group Relative to 7vPnC Group After the Infant Series
Diphtheria Toxoid
|
0.86 IU/mL
Interval 0.65 to 1.14
|
1.04 IU/mL
Interval 0.8 to 1.34
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration Diphtheria Toxoid and Anti-Tetanus Toxoid in 13vPnC Group Relative to 7vPnC Group After the Infant Series
Anti-Tetanus Toxoid
|
0.93 IU/mL
Interval 0.72 to 1.22
|
0.97 IU/mL
Interval 0.73 to 1.28
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: one month after the infant series (7 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 postinfant series blood sample.
Outcome measures
| Measure |
13vPnC Dose 1
n=94 Participants
Participants received one single 0.5mL dose of 13vPnC coadministered with Pediarix and ActHIB at 2 months of age (infant series Dose 1).
|
7vPnc Dose 1
n=108 Participants
Participants received one single 0.5mL dose of 7vPnC coadministered with Pediarix and ActHIB at 2 months of age (infant series Dose 1).
|
13vPnC Dose 2
Participants received one single 0.5mL dose of 13vPnC coadministered with Pediarix and ActHIB at 4 months of age (infant series Dose 2).
|
7vPnC Dose 2
Participants received one single 0.5mL dose of 7vPnC coadministered with Pediarix and ActHIB at 4 months of age (infant series Dose 2).
|
13vPnC Dose 3
Participants received one single 0.5mL dose of 13vPnC coadministered with Pediarix and ActHIB at 6 months of age (infant series Dose 3).
|
7vPnC Dose 3
Participants received one single 0.5mL dose of 7vPnC coadministered with Pediarix and ActHIB at 6 months of age (infant series Dose 3).
|
13vPnC Toddler Dose
Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12 to 15 months of age (toddler dose).
|
7vPnC Toddler Dose
Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12 to 15 months of age (toddler dose).
|
|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Antibody Concentration of Polio in 13vPnC Group Relative to 7vPnC Group After the Infant Series
Polio Type 1 (n=61,64)
|
483.72 titer
Interval 352.52 to 663.75
|
479.79 titer
Interval 361.79 to 636.26
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration of Polio in 13vPnC Group Relative to 7vPnC Group After the Infant Series
Polio Type 2 (n=61,64)
|
368.26 titer
Interval 250.75 to 540.84
|
403.45 titer
Interval 249.9 to 551.96
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration of Polio in 13vPnC Group Relative to 7vPnC Group After the Infant Series
Polio Type 3 (n=61,63)
|
914.01 titer
Interval 638.8 to 1307.8
|
812.75 titer
Interval 577.32 to 1144.18
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: one month after the infant series (7 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 concomitant vaccine component.
Outcome measures
| Measure |
13vPnC Dose 1
n=65 Participants
Participants received one single 0.5mL dose of 13vPnC coadministered with Pediarix and ActHIB at 2 months of age (infant series Dose 1).
|
7vPnc Dose 1
n=68 Participants
Participants received one single 0.5mL dose of 7vPnC coadministered with Pediarix and ActHIB at 2 months of age (infant series Dose 1).
|
13vPnC Dose 2
Participants received one single 0.5mL dose of 13vPnC coadministered with Pediarix and ActHIB at 4 months of age (infant series Dose 2).
|
7vPnC Dose 2
Participants received one single 0.5mL dose of 7vPnC coadministered with Pediarix and ActHIB at 4 months of age (infant series Dose 2).
|
13vPnC Dose 3
Participants received one single 0.5mL dose of 13vPnC coadministered with Pediarix and ActHIB at 6 months of age (infant series Dose 3).
|
7vPnC Dose 3
Participants received one single 0.5mL dose of 7vPnC coadministered with Pediarix and ActHIB at 6 months of age (infant series Dose 3).
|
13vPnC Toddler Dose
Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12 to 15 months of age (toddler dose).
|
7vPnC Toddler Dose
Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12 to 15 months of age (toddler dose).
|
|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Antibody Concentration of Pertussis Antigens in 13vPnC Group Relative to 7vPnC Group After the Infant Series
Pertussis - filamentous hemagglutinin (FHA)
|
207.85 EU/mL
Interval 178.72 to 241.74
|
225.12 EU/mL
Interval 191.97 to 264.01
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration of Pertussis Antigens in 13vPnC Group Relative to 7vPnC Group After the Infant Series
Pertussis - pertussis toxoid (PT)
|
98.68 EU/mL
Interval 82.89 to 117.49
|
96.58 EU/mL
Interval 86.45 to 107.89
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration of Pertussis Antigens in 13vPnC Group Relative to 7vPnC Group After the Infant Series
Pertussis - pertactin
|
141.23 EU/mL
Interval 113.02 to 176.48
|
135.51 EU/mL
Interval 107.13 to 171.41
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: one month after the infant series (7 months of age)Population: Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations;(n)=number of participants with a determinate postinfant series antibody titer to the given serotype.
Percentage of participants achieving functional antibody titer ≥1:8 as measured by opsonophagocytic activity assay (OPA) along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
Outcome measures
| Measure |
13vPnC Dose 1
n=94 Participants
Participants received one single 0.5mL dose of 13vPnC coadministered with Pediarix and ActHIB at 2 months of age (infant series Dose 1).
|
7vPnc Dose 1
n=108 Participants
Participants received one single 0.5mL dose of 7vPnC coadministered with Pediarix and ActHIB at 2 months of age (infant series Dose 1).
|
13vPnC Dose 2
Participants received one single 0.5mL dose of 13vPnC coadministered with Pediarix and ActHIB at 4 months of age (infant series Dose 2).
|
7vPnC Dose 2
Participants received one single 0.5mL dose of 7vPnC coadministered with Pediarix and ActHIB at 4 months of age (infant series Dose 2).
|
13vPnC Dose 3
Participants received one single 0.5mL dose of 13vPnC coadministered with Pediarix and ActHIB at 6 months of age (infant series Dose 3).
|
7vPnC Dose 3
Participants received one single 0.5mL dose of 7vPnC coadministered with Pediarix and ActHIB at 6 months of age (infant series Dose 3).
|
13vPnC Toddler Dose
Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12 to 15 months of age (toddler dose).
|
7vPnC Toddler Dose
Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12 to 15 months of age (toddler dose).
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Common Serotypes - Serotype 9V (n=27,27)
|
100.00 Percentage of participants
Interval 87.23 to 100.0
|
100.00 Percentage of participants
Interval 87.23 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Common Serotypes - Serotype 18C (n=27,30)
|
100.00 Percentage of participants
Interval 87.23 to 100.0
|
96.67 Percentage of participants
Interval 82.78 to 99.92
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Additional Serotypes - Serotype 1 (n=30,32)
|
83.33 Percentage of participants
Interval 65.28 to 94.36
|
6.25 Percentage of participants
Interval 0.77 to 20.81
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Additional Serotypes - Serotype 3 (n=25,29)
|
80.00 Percentage of participants
Interval 59.3 to 93.17
|
3.45 Percentage of participants
Interval 0.09 to 17.76
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Additional Serotypes - Serotype 19A (n=22,24)
|
77.27 Percentage of participants
Interval 54.63 to 92.18
|
12.50 Percentage of participants
Interval 2.66 to 32.36
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Common Serotypes - Serotype 4 (n=30,33)
|
96.67 Percentage of participants
Interval 82.78 to 99.92
|
100.00 Percentage of participants
Interval 89.42 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Common Serotypes - Serotype 6B (n=27,30)
|
92.59 Percentage of participants
Interval 75.71 to 99.09
|
93.33 Percentage of participants
Interval 77.93 to 99.18
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Common Serotypes - Serotype 14 (n=27,30)
|
100.00 Percentage of participants
Interval 87.23 to 100.0
|
100.00 Percentage of participants
Interval 88.43 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Common Serotypes - Serotype 19F (n=25,25)
|
84.00 Percentage of participants
Interval 63.92 to 95.46
|
80.00 Percentage of participants
Interval 59.3 to 93.17
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Common Serotypes - Serotype 23F (n=27,26)
|
92.59 Percentage of participants
Interval 75.71 to 99.09
|
100.00 Percentage of participants
Interval 86.77 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Additional Serotypes - Serotype 5 (n=30,33)
|
100.00 Percentage of participants
Interval 88.43 to 100.0
|
6.06 Percentage of participants
Interval 0.74 to 20.23
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Additional Serotypes - Serotype 6A (n=25,29)
|
96.00 Percentage of participants
Interval 79.65 to 99.9
|
48.28 Percentage of participants
Interval 29.45 to 67.47
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Additional Serotypes - Serotype 7F (n=22,24)
|
100.00 Percentage of participants
Interval 84.56 to 100.0
|
20.83 Percentage of participants
Interval 7.13 to 42.15
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: One month after the toddler dose (13 to 16 months of age)Population: All-available (per protocol) population consisting of eligible participants who had at least 1 valid and determinate assay result related to the proposed analysis; (n)= number of participants with determinant posttoddler dose antibody titer to the given serotype.
Percentage of participants achieving functional antibody titer ≥1:8 as measured by opsonophagocytic activity assay (OPA) along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) were assessed. Results are reported for the serotypes with a determinate antibody titer.
Outcome measures
| Measure |
13vPnC Dose 1
n=85 Participants
Participants received one single 0.5mL dose of 13vPnC coadministered with Pediarix and ActHIB at 2 months of age (infant series Dose 1).
|
7vPnc Dose 1
n=102 Participants
Participants received one single 0.5mL dose of 7vPnC coadministered with Pediarix and ActHIB at 2 months of age (infant series Dose 1).
|
13vPnC Dose 2
Participants received one single 0.5mL dose of 13vPnC coadministered with Pediarix and ActHIB at 4 months of age (infant series Dose 2).
|
7vPnC Dose 2
Participants received one single 0.5mL dose of 7vPnC coadministered with Pediarix and ActHIB at 4 months of age (infant series Dose 2).
|
13vPnC Dose 3
Participants received one single 0.5mL dose of 13vPnC coadministered with Pediarix and ActHIB at 6 months of age (infant series Dose 3).
|
7vPnC Dose 3
Participants received one single 0.5mL dose of 7vPnC coadministered with Pediarix and ActHIB at 6 months of age (infant series Dose 3).
|
13vPnC Toddler Dose
Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12 to 15 months of age (toddler dose).
|
7vPnC Toddler Dose
Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12 to 15 months of age (toddler dose).
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose
Additional Serotypes - Serotype 6A (n=73,70)
|
100.00 Percentage of participants
Interval 95.1 to 100.0
|
90.0 Percentage of participants
Interval 80.5 to 95.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose
Additional Serotypes - Serotype 19A (n=71,72)
|
100.00 Percentage of participants
Interval 94.9 to 100.0
|
51.4 Percentage of participants
Interval 39.3 to 63.3
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: One month after the Toddler Dose (13 to 16 months of age)Population: All-available (per protocol) population consisting of eligible participants who had at least 1 valid and determinate assay result related to the proposed analysis; (n)=number of participants with a determinant antibody titer for the specified serotype.
Antibody functionality/geometric mean titer (GMT) as measured by opsonophagocytic activity assay (OPA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) were assessed. Results are reported for the serotypes with a determinate antibody titer.
Outcome measures
| Measure |
13vPnC Dose 1
n=85 Participants
Participants received one single 0.5mL dose of 13vPnC coadministered with Pediarix and ActHIB at 2 months of age (infant series Dose 1).
|
7vPnc Dose 1
n=102 Participants
Participants received one single 0.5mL dose of 7vPnC coadministered with Pediarix and ActHIB at 2 months of age (infant series Dose 1).
|
13vPnC Dose 2
Participants received one single 0.5mL dose of 13vPnC coadministered with Pediarix and ActHIB at 4 months of age (infant series Dose 2).
|
7vPnC Dose 2
Participants received one single 0.5mL dose of 7vPnC coadministered with Pediarix and ActHIB at 4 months of age (infant series Dose 2).
|
13vPnC Dose 3
Participants received one single 0.5mL dose of 13vPnC coadministered with Pediarix and ActHIB at 6 months of age (infant series Dose 3).
|
7vPnC Dose 3
Participants received one single 0.5mL dose of 7vPnC coadministered with Pediarix and ActHIB at 6 months of age (infant series Dose 3).
|
13vPnC Toddler Dose
Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12 to 15 months of age (toddler dose).
|
7vPnC Toddler Dose
Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12 to 15 months of age (toddler dose).
|
|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Antibody Titer (OPA) in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose
Additional Serotypes - Serotype 6A (n=73,70)
|
2147.58 titer
Interval 1630.73 to 2828.23
|
599.90 titer
Interval 375.83 to 957.54
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Titer (OPA) in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose
Additional Serotypes - Serotype 19A (n=71,72)
|
802.24 titer
Interval 633.92 to 1015.24
|
36.62 titer
Interval 21.09 to 63.59
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
13vPnC Infant Series
Serious events: 9 serious events
Other events: 104 other events
Deaths: 0 deaths
7vPnC Infant Series
Serious events: 9 serious events
Other events: 110 other events
Deaths: 0 deaths
13vPnC Toddler Dose
Serious events: 1 serious events
Other events: 33 other events
Deaths: 0 deaths
7vPnC Toddler Dose
Serious events: 0 serious events
Other events: 51 other events
Deaths: 0 deaths
13vPnC 6-Month Follow-up
Serious events: 4 serious events
Other events: 20 other events
Deaths: 0 deaths
7vPnC 6-Month Follow-up
Serious events: 1 serious events
Other events: 33 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
13vPnC Infant Series
n=120 participants at risk
Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series).
|
7vPnC Infant Series
n=126 participants at risk
Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series).
|
13vPnC Toddler Dose
n=86 participants at risk
Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12 to 15 months of age (toddler dose).
|
7vPnC Toddler Dose
n=103 participants at risk
Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12 to 15 months of age (toddler dose).
|
13vPnC 6-Month Follow-up
n=86 participants at risk
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
|
7vPnC 6-Month Follow-up
n=103 participants at risk
Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
|
|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Asthma exacerbation
|
0.00%
0/120
|
0.00%
0/126
|
0.00%
0/86
|
0.00%
0/103
|
1.2%
1/86
|
0.97%
1/103
|
|
Infections and infestations
Bilateral otitis media
|
0.83%
1/120
|
0.00%
0/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Infections and infestations
Bronchiolitis
|
2.5%
3/120
|
2.4%
3/126
|
0.00%
0/86
|
0.00%
0/103
|
1.2%
1/86
|
0.00%
0/103
|
|
Infections and infestations
Bronchiolitis RSV
|
0.83%
1/120
|
0.00%
0/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Congenital, familial and genetic disorders
Chairi I malformation
|
0.83%
1/120
|
0.00%
0/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Nervous system disorders
Complex febrile seizure
|
0.00%
0/120
|
0.00%
0/126
|
0.00%
0/86
|
0.00%
0/103
|
1.2%
1/86
|
0.00%
0/103
|
|
Infections and infestations
Cystitis
|
0.83%
1/120
|
0.00%
0/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Metabolism and nutrition disorders
Dehydration
|
1.7%
2/120
|
1.6%
2/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Infections and infestations
Febrile illness (fever)
|
0.00%
0/120
|
0.79%
1/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Nervous system disorders
Febrile seizure
|
0.83%
1/120
|
0.00%
0/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Infections and infestations
Fever of unknown origin
|
0.83%
1/120
|
0.00%
0/126
|
0.00%
0/86
|
0.00%
0/103
|
1.2%
1/86
|
0.00%
0/103
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.83%
1/120
|
0.79%
1/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.83%
1/120
|
0.00%
0/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
General disorders
Irritability
|
0.83%
1/120
|
0.00%
0/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.83%
1/120
|
0.00%
0/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.83%
1/120
|
0.00%
0/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Infections and infestations
Otitis media
|
0.83%
1/120
|
0.00%
0/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Infections and infestations
Pneumococcal meningitis
|
0.00%
0/120
|
0.79%
1/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia right middle lobe
|
0.00%
0/120
|
0.79%
1/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Respiratory, thoracic and mediastinal disorders
RSV positive bronchiolitis
|
0.00%
0/120
|
0.79%
1/126
|
0.00%
0/86
|
0.00%
0/103
|
1.2%
1/86
|
0.00%
0/103
|
|
Respiratory, thoracic and mediastinal disorders
Right upper and left lower lobe pneumonia
|
0.00%
0/120
|
0.79%
1/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Gastrointestinal disorders
Rotaviral diarrhea
|
0.00%
0/120
|
0.79%
1/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Nervous system disorders
Seizure
|
0.00%
0/120
|
0.00%
0/126
|
0.00%
0/86
|
0.00%
0/103
|
1.2%
1/86
|
0.00%
0/103
|
|
Nervous system disorders
Sensory integration disorder
|
0.83%
1/120
|
0.00%
0/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Infections and infestations
Staphylococcal infection (hand)
|
0.83%
1/120
|
0.00%
0/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Respiratory, thoracic and mediastinal disorders
Status asthmaticus
|
0.00%
0/120
|
0.00%
0/126
|
1.2%
1/86
|
0.00%
0/103
|
2.3%
2/86
|
0.00%
0/103
|
|
Nervous system disorders
Tethered cord syndrome
|
0.83%
1/120
|
0.00%
0/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/120
|
0.79%
1/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Infections and infestations
Viral URI
|
0.00%
0/120
|
0.00%
0/126
|
0.00%
0/86
|
0.00%
0/103
|
1.2%
1/86
|
0.00%
0/103
|
|
Infections and infestations
Viral conjunctivitis
|
0.00%
0/120
|
0.00%
0/126
|
1.2%
1/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Infections and infestations
Viral respiratory infection
|
0.00%
0/120
|
0.00%
0/126
|
1.2%
1/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Gastrointestinal disorders
Vomiting
|
0.83%
1/120
|
0.00%
0/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
Other adverse events
| Measure |
13vPnC Infant Series
n=120 participants at risk
Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series).
|
7vPnC Infant Series
n=126 participants at risk
Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series).
|
13vPnC Toddler Dose
n=86 participants at risk
Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12 to 15 months of age (toddler dose).
|
7vPnC Toddler Dose
n=103 participants at risk
Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12 to 15 months of age (toddler dose).
|
13vPnC 6-Month Follow-up
n=86 participants at risk
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
|
7vPnC 6-Month Follow-up
n=103 participants at risk
Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Pneumonia primary atypical
|
0.83%
1/120
|
0.00%
0/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Infections and infestations
Rash pustular
|
0.83%
1/120
|
0.00%
0/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/120
|
0.79%
1/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Infections and infestations
Rhinitis
|
0.00%
0/120
|
0.79%
1/126
|
0.00%
0/86
|
0.97%
1/103
|
4.7%
4/86
|
0.97%
1/103
|
|
Infections and infestations
Staphylococcal infection
|
0.83%
1/120
|
0.00%
0/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.97%
1/103
|
|
Infections and infestations
Tinea versicolour
|
0.83%
1/120
|
0.00%
0/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Injury, poisoning and procedural complications
Fall
|
1.7%
2/120
|
0.00%
0/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.83%
1/120
|
0.00%
0/126
|
2.3%
2/86
|
1.9%
2/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/120
|
0.79%
1/126
|
0.00%
0/86
|
0.97%
1/103
|
0.00%
0/86
|
0.97%
1/103
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/120
|
0.79%
1/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.83%
1/120
|
0.00%
0/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Injury, poisoning and procedural complications
Traumatic brain injury
|
0.83%
1/120
|
0.00%
0/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.97%
1/103
|
|
Investigations
Cardiac murmur
|
0.83%
1/120
|
0.79%
1/126
|
1.2%
1/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Investigations
Cardiac murmur functional
|
0.00%
0/120
|
1.6%
2/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Metabolism and nutrition disorders
Decreased appetite
|
3.3%
4/120
|
2.4%
3/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Metabolism and nutrition disorders
Dehydration
|
0.83%
1/120
|
1.6%
2/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
1.9%
2/103
|
|
Metabolism and nutrition disorders
Food intolerance
|
1.7%
2/120
|
0.79%
1/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/120
|
0.79%
1/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.83%
1/120
|
0.00%
0/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Metabolism and nutrition disorders
Hypervitaminosis a
|
0.00%
0/120
|
0.79%
1/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Metabolism and nutrition disorders
Lactose intolerance
|
0.00%
0/120
|
0.79%
1/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Musculoskeletal and connective tissue disorders
Torticollis
|
0.00%
0/120
|
1.6%
2/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma
|
0.83%
1/120
|
0.00%
0/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.00%
0/120
|
0.79%
1/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Nervous system disorders
Hypersomnia
|
0.83%
1/120
|
2.4%
3/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Nervous system disorders
Hypertonia
|
0.00%
0/120
|
0.79%
1/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Nervous system disorders
Hypotonia
|
0.83%
1/120
|
0.00%
0/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Nervous system disorders
Somnolence
|
0.83%
1/120
|
0.00%
0/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Psychiatric disorders
Insomnia
|
1.7%
2/120
|
1.6%
2/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Renal and urinary disorders
Vesicoureteric reflux
|
0.00%
0/120
|
0.79%
1/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Reproductive system and breast disorders
Penile blister
|
0.00%
0/120
|
0.79%
1/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/120
|
0.79%
1/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.5%
9/120
|
12.7%
16/126
|
1.2%
1/86
|
0.97%
1/103
|
1.2%
1/86
|
2.9%
3/103
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
6.7%
8/120
|
13.5%
17/126
|
1.2%
1/86
|
2.9%
3/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
9.2%
11/120
|
6.3%
8/126
|
3.5%
3/86
|
2.9%
3/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.83%
1/120
|
0.00%
0/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Congenital, familial and genetic disorders
Plagiocephaly
|
1.7%
2/120
|
2.4%
3/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Congenital, familial and genetic disorders
Dacryostenosis congenital
|
1.7%
2/120
|
0.79%
1/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Congenital, familial and genetic disorders
Ankyloglossia congenital
|
0.83%
1/120
|
0.00%
0/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Congenital, familial and genetic disorders
Macrocephaly
|
0.83%
1/120
|
0.00%
0/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Ear and labyrinth disorders
Ear pain
|
0.83%
1/120
|
0.79%
1/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.83%
1/120
|
0.00%
0/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Eye disorders
Conjunctivitis
|
10.8%
13/120
|
12.7%
16/126
|
0.00%
0/86
|
0.97%
1/103
|
0.00%
0/86
|
3.9%
4/103
|
|
Eye disorders
Dacryostenosis acquired
|
2.5%
3/120
|
1.6%
2/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Eye disorders
Conjunctival haemorrhage
|
0.83%
1/120
|
0.00%
0/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Eye disorders
Eyelid ptosis
|
0.83%
1/120
|
0.00%
0/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Eye disorders
Strabismus
|
0.00%
0/120
|
0.79%
1/126
|
0.00%
0/86
|
0.97%
1/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Gastrointestinal disorders
Diarrhoea
|
5.8%
7/120
|
13.5%
17/126
|
2.3%
2/86
|
5.8%
6/103
|
0.00%
0/86
|
1.9%
2/103
|
|
Gastrointestinal disorders
Vomiting
|
6.7%
8/120
|
7.9%
10/126
|
1.2%
1/86
|
5.8%
6/103
|
0.00%
0/86
|
0.97%
1/103
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.7%
2/120
|
6.3%
8/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Gastrointestinal disorders
Constipation
|
1.7%
2/120
|
3.2%
4/126
|
1.2%
1/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Gastrointestinal disorders
Umbilical hernia
|
3.3%
4/120
|
1.6%
2/126
|
0.00%
0/86
|
0.97%
1/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Gastrointestinal disorders
Teething
|
1.7%
2/120
|
1.6%
2/126
|
0.00%
0/86
|
1.9%
2/103
|
1.2%
1/86
|
0.00%
0/103
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/120
|
0.79%
1/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/120
|
0.79%
1/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Gastrointestinal disorders
Glossodynia
|
0.83%
1/120
|
0.00%
0/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Gastrointestinal disorders
Infantile spitting up
|
0.00%
0/120
|
0.79%
1/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Gastrointestinal disorders
Mouth cyst
|
0.00%
0/120
|
0.79%
1/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/120
|
0.79%
1/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
General disorders
Pyrexia
|
8.3%
10/120
|
9.5%
12/126
|
1.2%
1/86
|
1.9%
2/103
|
1.2%
1/86
|
2.9%
3/103
|
|
General disorders
Irritability
|
51.4%
55/107
|
53.8%
63/117
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
General disorders
Granuloma
|
1.7%
2/120
|
0.00%
0/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
General disorders
Xerosis
|
1.7%
2/120
|
0.00%
0/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Immune system disorders
Allergy to chemicals
|
0.83%
1/120
|
0.00%
0/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Immune system disorders
Drug hypersensitivity
|
0.83%
1/120
|
0.00%
0/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.97%
1/103
|
|
Immune system disorders
Hypersensitivity
|
0.83%
1/120
|
0.00%
0/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Immune system disorders
Seasonal allergy
|
0.83%
1/120
|
0.00%
0/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Infections and infestations
Upper respiratory tract infection
|
47.5%
57/120
|
51.6%
65/126
|
9.3%
8/86
|
9.7%
10/103
|
5.8%
5/86
|
11.7%
12/103
|
|
Infections and infestations
Otitis media
|
33.3%
40/120
|
29.4%
37/126
|
1.2%
1/86
|
9.7%
10/103
|
10.5%
9/86
|
13.6%
14/103
|
|
Infections and infestations
Bronchiolitis
|
10.8%
13/120
|
10.3%
13/126
|
0.00%
0/86
|
0.97%
1/103
|
0.00%
0/86
|
1.9%
2/103
|
|
Infections and infestations
Otitis media acute
|
5.8%
7/120
|
12.7%
16/126
|
1.2%
1/86
|
1.9%
2/103
|
2.3%
2/86
|
1.9%
2/103
|
|
Infections and infestations
Viral infection
|
7.5%
9/120
|
9.5%
12/126
|
1.2%
1/86
|
2.9%
3/103
|
1.2%
1/86
|
1.9%
2/103
|
|
Infections and infestations
Candida nappy rash
|
6.7%
8/120
|
5.6%
7/126
|
1.2%
1/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Infections and infestations
Viral upper respiratory tract infection
|
5.0%
6/120
|
6.3%
8/126
|
1.2%
1/86
|
0.00%
0/103
|
0.00%
0/86
|
0.97%
1/103
|
|
Infections and infestations
Gastroenteritis
|
5.8%
7/120
|
3.2%
4/126
|
0.00%
0/86
|
0.00%
0/103
|
2.3%
2/86
|
3.9%
4/103
|
|
Infections and infestations
Oral candidiasis
|
6.7%
8/120
|
1.6%
2/126
|
0.00%
0/86
|
0.00%
0/103
|
2.3%
2/86
|
0.00%
0/103
|
|
Infections and infestations
Croup infectious
|
2.5%
3/120
|
4.8%
6/126
|
3.5%
3/86
|
0.97%
1/103
|
1.2%
1/86
|
3.9%
4/103
|
|
Infections and infestations
Nasopharyngitis
|
3.3%
4/120
|
4.0%
5/126
|
1.2%
1/86
|
0.97%
1/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Infections and infestations
Pneumonia
|
3.3%
4/120
|
4.0%
5/126
|
0.00%
0/86
|
0.00%
0/103
|
2.3%
2/86
|
1.9%
2/103
|
|
Infections and infestations
Gastroenteritis viral
|
3.3%
4/120
|
2.4%
3/126
|
0.00%
0/86
|
0.97%
1/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Infections and infestations
Viral pharyngitis
|
2.5%
3/120
|
3.2%
4/126
|
1.2%
1/86
|
0.97%
1/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Infections and infestations
Candidiasis
|
0.83%
1/120
|
4.0%
5/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Infections and infestations
Sinusitis
|
1.7%
2/120
|
3.2%
4/126
|
1.2%
1/86
|
0.00%
0/103
|
1.2%
1/86
|
1.9%
2/103
|
|
Infections and infestations
Bronchitis
|
1.7%
2/120
|
2.4%
3/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
1.9%
2/103
|
|
Infections and infestations
Pharyngitis
|
3.3%
4/120
|
0.79%
1/126
|
0.00%
0/86
|
0.97%
1/103
|
1.2%
1/86
|
1.9%
2/103
|
|
Infections and infestations
Viral rash
|
2.5%
3/120
|
1.6%
2/126
|
1.2%
1/86
|
1.9%
2/103
|
2.3%
2/86
|
0.00%
0/103
|
|
Infections and infestations
Respiratory syncytial virus bronchiolitis
|
1.7%
2/120
|
0.79%
1/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Infections and infestations
Skin candida
|
0.83%
1/120
|
1.6%
2/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Infections and infestations
Acarodermatitis
|
1.7%
2/120
|
0.00%
0/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Infections and infestations
Body tinea
|
1.7%
2/120
|
0.00%
0/126
|
0.00%
0/86
|
0.97%
1/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Infections and infestations
Roseola
|
1.7%
2/120
|
0.00%
0/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Infections and infestations
Tinea infection
|
0.83%
1/120
|
0.79%
1/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Infections and infestations
Varicella
|
0.83%
1/120
|
0.79%
1/126
|
0.00%
0/86
|
1.9%
2/103
|
0.00%
0/86
|
1.9%
2/103
|
|
Infections and infestations
Acute tonsillitis
|
0.83%
1/120
|
0.00%
0/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Infections and infestations
Dacryocystitis
|
0.83%
1/120
|
0.00%
0/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Infections and infestations
Eczema infected
|
0.83%
1/120
|
0.00%
0/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Infections and infestations
Erythema infectiosum
|
0.00%
0/120
|
0.79%
1/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Infections and infestations
Exanthema subitum
|
0.00%
0/120
|
0.79%
1/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/120
|
0.79%
1/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Infections and infestations
Herpangina
|
0.83%
1/120
|
0.00%
0/126
|
0.00%
0/86
|
1.9%
2/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Infections and infestations
Infection
|
0.83%
1/120
|
0.00%
0/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Infections and infestations
Localised infection
|
0.83%
1/120
|
0.00%
0/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Infections and infestations
Nail infection
|
0.83%
1/120
|
0.00%
0/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Infections and infestations
Paronychia
|
0.83%
1/120
|
0.00%
0/126
|
0.00%
0/86
|
0.00%
0/103
|
1.2%
1/86
|
0.00%
0/103
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
4.2%
5/120
|
5.6%
7/126
|
1.2%
1/86
|
1.9%
2/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
2.5%
3/120
|
1.6%
2/126
|
1.2%
1/86
|
0.00%
0/103
|
1.2%
1/86
|
1.9%
2/103
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
2.5%
3/120
|
1.6%
2/126
|
0.00%
0/86
|
0.97%
1/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
1.7%
2/120
|
0.00%
0/126
|
0.00%
0/86
|
1.9%
2/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Respiratory, thoracic and mediastinal disorders
Tracheomalacia
|
0.83%
1/120
|
0.79%
1/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Respiratory, thoracic and mediastinal disorders
Choking
|
0.00%
0/120
|
0.79%
1/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.83%
1/120
|
0.00%
0/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Respiratory, thoracic and mediastinal disorders
Macleod's syndrome
|
0.00%
0/120
|
0.79%
1/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/120
|
0.79%
1/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/120
|
0.79%
1/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
5.8%
7/120
|
7.9%
10/126
|
1.2%
1/86
|
0.97%
1/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Skin and subcutaneous tissue disorders
Eczema
|
8.3%
10/120
|
4.8%
6/126
|
1.2%
1/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.7%
2/120
|
5.6%
7/126
|
1.2%
1/86
|
2.9%
3/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
1.7%
2/120
|
3.2%
4/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
2.5%
3/120
|
1.6%
2/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
1.7%
2/120
|
0.79%
1/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.83%
1/120
|
0.79%
1/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.83%
1/120
|
0.79%
1/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.83%
1/120
|
0.79%
1/126
|
1.2%
1/86
|
0.00%
0/103
|
0.00%
0/86
|
0.97%
1/103
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.83%
1/120
|
0.00%
0/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/120
|
0.79%
1/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Skin and subcutaneous tissue disorders
Heat rash
|
0.83%
1/120
|
0.00%
0/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.83%
1/120
|
0.00%
0/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.83%
1/120
|
0.00%
0/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/120
|
0.79%
1/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/120
|
0.79%
1/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/120
|
0.79%
1/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Social circumstances
Corrective lens user
|
0.00%
0/120
|
0.79%
1/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Social circumstances
Exposure to communicable disease
|
0.83%
1/120
|
0.00%
0/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/120
|
0.00%
0/126
|
1.2%
1/86
|
1.9%
2/103
|
0.00%
0/86
|
0.97%
1/103
|
|
Ear and labyrinth disorders
Middle ear effusion
|
0.00%
0/120
|
0.00%
0/126
|
1.2%
1/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Ear and labyrinth disorders
Otorrhoea
|
0.00%
0/120
|
0.00%
0/126
|
0.00%
0/86
|
0.97%
1/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Eye disorders
Scleral hyperaemia
|
0.00%
0/120
|
0.00%
0/126
|
0.00%
0/86
|
0.97%
1/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/120
|
0.00%
0/126
|
0.00%
0/86
|
0.97%
1/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/120
|
0.00%
0/126
|
0.00%
0/86
|
0.97%
1/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/120
|
0.00%
0/126
|
1.2%
1/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Infections and infestations
Folliculitis
|
0.00%
0/120
|
0.00%
0/126
|
0.00%
0/86
|
0.97%
1/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Infections and infestations
Influenza
|
0.00%
0/120
|
0.00%
0/126
|
0.00%
0/86
|
0.97%
1/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/120
|
0.00%
0/126
|
1.2%
1/86
|
0.00%
0/103
|
1.2%
1/86
|
0.00%
0/103
|
|
Infections and infestations
Tinea capitis
|
0.00%
0/120
|
0.00%
0/126
|
0.00%
0/86
|
1.9%
2/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/120
|
0.00%
0/126
|
1.2%
1/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/120
|
0.00%
0/126
|
0.00%
0/86
|
0.97%
1/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.00%
0/120
|
0.00%
0/126
|
0.00%
0/86
|
0.97%
1/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Injury, poisoning and procedural complications
Exposure to toxic agent
|
0.00%
0/120
|
0.00%
0/126
|
0.00%
0/86
|
0.97%
1/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Metabolism and nutrition disorders
Weight gain poor
|
0.00%
0/120
|
0.00%
0/126
|
1.2%
1/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Nervous system disorders
Speech disorder developmental
|
0.00%
0/120
|
0.00%
0/126
|
0.00%
0/86
|
0.97%
1/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/120
|
0.00%
0/126
|
0.00%
0/86
|
0.97%
1/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Renal and urinary disorders
Penile adhesion
|
0.00%
0/120
|
0.00%
0/126
|
1.2%
1/86
|
0.97%
1/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Skin and subcutaneous tissue disorders
Acne infantile
|
0.00%
0/120
|
0.00%
0/126
|
0.00%
0/86
|
0.97%
1/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/120
|
0.00%
0/126
|
1.2%
1/86
|
0.00%
0/103
|
0.00%
0/86
|
0.97%
1/103
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/120
|
0.00%
0/126
|
1.2%
1/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Skin and subcutaneous tissue disorders
Keratosis pilaris
|
0.00%
0/120
|
0.00%
0/126
|
0.00%
0/86
|
0.97%
1/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Congenital, familial and genetic disorders
Thalassaemia alpha
|
0.00%
0/120
|
0.00%
0/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.97%
1/103
|
|
Immune system disorders
Food allergy
|
0.00%
0/120
|
0.00%
0/126
|
0.00%
0/86
|
0.00%
0/103
|
1.2%
1/86
|
0.00%
0/103
|
|
Immune system disorders
Cellulitis orbital
|
0.00%
0/120
|
0.00%
0/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.97%
1/103
|
|
Infections and infestations
Conjunctivitis infective
|
0.00%
0/120
|
0.00%
0/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.97%
1/103
|
|
Infections and infestations
Oral herpes
|
0.00%
0/120
|
0.00%
0/126
|
0.00%
0/86
|
0.00%
0/103
|
1.2%
1/86
|
0.00%
0/103
|
|
Infections and infestations
Rotavirus infection
|
0.00%
0/120
|
0.00%
0/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.97%
1/103
|
|
Injury, poisoning and procedural complications
Back injury
|
0.00%
0/120
|
0.00%
0/126
|
0.00%
0/86
|
0.00%
0/103
|
1.2%
1/86
|
0.00%
0/103
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/120
|
0.00%
0/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.97%
1/103
|
|
Musculoskeletal and connective tissue disorders
Weight bearing difficulty
|
0.00%
0/120
|
0.00%
0/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.97%
1/103
|
|
Nervous system disorders
Febrile convulsion
|
0.00%
0/120
|
0.00%
0/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.97%
1/103
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/120
|
0.00%
0/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.97%
1/103
|
|
Eye disorders
Eye disorder
|
0.83%
1/120
|
0.00%
0/126
|
0.00%
0/86
|
0.00%
0/103
|
0.00%
0/86
|
0.00%
0/103
|
|
Skin and subcutaneous tissue disorders
Tenderness (Any)
|
24.3%
26/107
|
25.6%
30/117
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
Skin and subcutaneous tissue disorders
Tenderness (Significant)
|
4.7%
5/107
|
6.0%
7/117
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
Skin and subcutaneous tissue disorders
Induration (Any)
|
16.8%
18/107
|
18.8%
22/117
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
Skin and subcutaneous tissue disorders
Induration (Mild)
|
16.8%
18/107
|
17.2%
20/116
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
Skin and subcutaneous tissue disorders
Induration (Moderate)
|
0.00%
0/107
|
4.3%
5/116
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
Skin and subcutaneous tissue disorders
Induration (Severe)
|
0.00%
0/107
|
0.00%
0/116
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
Skin and subcutaneous tissue disorders
Erythema (Any)
|
17.8%
19/107
|
19.7%
23/117
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
Skin and subcutaneous tissue disorders
Erythema (Mild)
|
16.0%
17/106
|
18.1%
21/116
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
Skin and subcutaneous tissue disorders
Erythema (Moderate)
|
0.94%
1/106
|
2.6%
3/116
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
Skin and subcutaneous tissue disorders
Erythema (Severe)
|
0.00%
0/106
|
0.00%
0/116
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
General disorders
Fever ≥38°C but≤39°C
|
20.0%
20/100
|
20.4%
23/113
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
General disorders
Fever >39°C but≤40°C
|
2.0%
2/101
|
0.88%
1/113
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
General disorders
Fever >40°C
|
0.00%
0/100
|
0.00%
0/113
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
General disorders
Decreased appetite
|
27.1%
29/107
|
30.8%
36/117
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
General disorders
Decreased sleep
|
21.5%
23/107
|
18.8%
22/117
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
General disorders
Increased sleep
|
34.6%
37/107
|
41.0%
48/117
|
—
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