Trial Outcomes & Findings for Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Japanese Infants (NCT NCT00574795)
NCT ID: NCT00574795
Last Updated: 2012-08-08
Results Overview
Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥ 0.35 μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
193 participants
Primary outcome timeframe
one month after 3-dose infant series (at 7 months of age)
Results posted on
2012-08-08
Participant Flow
Participants were recruited in Japan from September 2007 to February 2008.
Participants were enrolled into the study according to inclusion/exclusion criteria without a screening period.
Participant milestones
| Measure |
13vPnC
Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 2, 4, 6 months (infant series) and 12-15 months of age (toddler dose).
|
|---|---|
|
Infant Series
STARTED
|
193
|
|
Infant Series
Vaccinated Dose 1
|
193
|
|
Infant Series
Vaccinated Dose 2
|
190
|
|
Infant Series
Vaccinated Dose 3
|
190
|
|
Infant Series
COMPLETED
|
188
|
|
Infant Series
NOT COMPLETED
|
5
|
|
After Infant Series
STARTED
|
188
|
|
After Infant Series
COMPLETED
|
185
|
|
After Infant Series
NOT COMPLETED
|
3
|
|
Toddler Dose
STARTED
|
185
|
|
Toddler Dose
COMPLETED
|
184
|
|
Toddler Dose
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
13vPnC
Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 2, 4, 6 months (infant series) and 12-15 months of age (toddler dose).
|
|---|---|
|
Infant Series
Withdrawal by Subject
|
2
|
|
Infant Series
Protocol Violation
|
2
|
|
Infant Series
Adverse Event
|
1
|
|
After Infant Series
Withdrawal by Subject
|
1
|
|
After Infant Series
Adverse Event
|
2
|
|
Toddler Dose
Withdrawal by Subject
|
1
|
Baseline Characteristics
Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Japanese Infants
Baseline characteristics by cohort
| Measure |
13vPnC
n=193 Participants
Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 2, 4, 6 months (infant series) and 12-15 months of age (toddler dose).
|
|---|---|
|
Age Continuous
|
3.7 months
STANDARD_DEVIATION 1.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
93 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
100 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: one month after 3-dose infant series (at 7 months of age)Population: Evaluable immunogenicity population had valid and determinate assay results and had no other major protocol violations.
Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥ 0.35 μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
Outcome measures
| Measure |
13vPnC After Infant Series
n=176 Participants
Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 2, 4, 6 months (infant series).
|
13vPnC Dose 2
Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 4 months of age (infant series Dose 2).
|
13vPnC Dose 3
Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 6 months of age (infant series Dose 3).
|
13vPnC Toddler Dose
Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 12-15 months of age (toddler dose).
|
|---|---|---|---|---|
|
Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the 3-Dose Infant Series
Common Serotypes - Serotype 4
|
100.0 percentage of participants
Interval 97.9 to 100.0
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the 3-Dose Infant Series
Common Serotypes - Serotype 6B
|
98.3 percentage of participants
Interval 95.1 to 99.6
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the 3-Dose Infant Series
Common Serotypes - Serotype 9V
|
100.0 percentage of participants
Interval 97.9 to 100.0
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the 3-Dose Infant Series
Common Serotypes - Serotype 14
|
100.0 percentage of participants
Interval 97.9 to 100.0
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the 3-Dose Infant Series
Common Serotypes - Serotype 18C
|
100.0 percentage of participants
Interval 97.9 to 100.0
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the 3-Dose Infant Series
Common Serotypes - Serotype 19F
|
97.2 percentage of participants
Interval 93.5 to 99.1
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the 3-Dose Infant Series
Common Serotypes - Serotype 23F
|
97.7 percentage of participants
Interval 94.3 to 99.4
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the 3-Dose Infant Series
Additional Serotypes - Serotype 1
|
100.0 percentage of participants
Interval 97.9 to 100.0
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the 3-Dose Infant Series
Additional Serotypes - Serotype 3
|
100.0 percentage of participants
Interval 97.9 to 100.0
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the 3-Dose Infant Series
Additional Serotypes - Serotype 5
|
100.0 percentage of participants
Interval 97.9 to 100.0
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the 3-Dose Infant Series
Additional Serotypes - Serotype 6A
|
100.0 percentage of participants
Interval 97.9 to 100.0
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the 3-Dose Infant Series
Additional Serotypes - Serotype 7F
|
100.0 percentage of participants
Interval 97.9 to 100.0
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the 3-Dose Infant Series
Additional Serotypes - Serotype 19A
|
100.0 percentage of participants
Interval 97.9 to 100.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: one mone month after 3-dose infant series (at 7 months of age)Population: Evaluable immunogenicity population had valid and determinate assay results, and had no other major protocol violations.
GMC as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
Outcome measures
| Measure |
13vPnC After Infant Series
n=176 Participants
Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 2, 4, 6 months (infant series).
|
13vPnC Dose 2
Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 4 months of age (infant series Dose 2).
|
13vPnC Dose 3
Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 6 months of age (infant series Dose 3).
|
13vPnC Toddler Dose
Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 12-15 months of age (toddler dose).
|
|---|---|---|---|---|
|
Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the 3-Dose Infant Series
Common Serotypes - Serotype 4
|
6.76 μg/mL
Interval 6.02 to 7.59
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the 3-Dose Infant Series
Common Serotypes - Serotype 6B
|
4.77 μg/mL
Interval 4.07 to 5.59
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the 3-Dose Infant Series
Common Serotypes - Serotype 9V
|
3.39 μg/mL
Interval 3.03 to 3.78
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the 3-Dose Infant Series
Common Serotypes - Serotype 14
|
14.69 μg/mL
Interval 13.26 to 16.26
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the 3-Dose Infant Series
Common Serotypes - Serotype 18C
|
3.68 μg/mL
Interval 3.27 to 4.14
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the 3-Dose Infant Series
Common Serotypes - Serotype 19F
|
5.71 μg/mL
Interval 4.9 to 6.65
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the 3-Dose Infant Series
Common Serotypes - Serotype 23F
|
2.57 μg/mL
Interval 2.21 to 3.0
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the 3-Dose Infant Series
Additional Serotypes - Serotype 1
|
5.11 μg/mL
Interval 4.48 to 5.82
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the 3-Dose Infant Series
Additional Serotypes - Serotype 3
|
2.87 μg/mL
Interval 2.55 to 3.24
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the 3-Dose Infant Series
Additional Serotypes - Serotype 5
|
3.85 μg/mL
Interval 3.42 to 4.33
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the 3-Dose Infant Series
Additional Serotypes - Serotype 6A
|
3.77 μg/mL
Interval 3.35 to 4.25
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the 3-Dose Infant Series
Additional Serotypes - Serotype 7F
|
5.78 μg/mL
Interval 5.19 to 6.45
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the 3-Dose Infant Series
Additional Serotypes - Serotype 19A
|
6.97 μg/mL
Interval 6.25 to 7.77
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: one month after the toddler dose (at 12 - 15 months of age)Population: Evaluable immunogenicity population had valid and determinate assay results, and had no other major protocol violations.
Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥ 0.35 μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
Outcome measures
| Measure |
13vPnC After Infant Series
n=178 Participants
Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 2, 4, 6 months (infant series).
|
13vPnC Dose 2
Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 4 months of age (infant series Dose 2).
|
13vPnC Dose 3
Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 6 months of age (infant series Dose 3).
|
13vPnC Toddler Dose
Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 12-15 months of age (toddler dose).
|
|---|---|---|---|---|
|
Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the Toddler Dose
Additional Serotypes - Serotype 3
|
99.4 percentage of participants
Interval 96.9 to 100.0
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the Toddler Dose
Additional Serotypes - Serotype 5
|
100 percentage of participants
Interval 97.9 to 100.0
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the Toddler Dose
Additional Serotypes - Serotype 6A
|
100 percentage of participants
Interval 97.9 to 100.0
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the Toddler Dose
Additional Serotypes - Serotype 7F
|
100 percentage of participants
Interval 97.9 to 100.0
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the Toddler Dose
Common Serotypes - Serotype 4
|
100 percentage of participants
Interval 97.9 to 100.0
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the Toddler Dose
Common Serotypes - Serotype 6B
|
100 percentage of participants
Interval 97.9 to 100.0
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the Toddler Dose
Common Serotypes - Serotype 9V
|
100 percentage of participants
Interval 97.9 to 100.0
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the Toddler Dose
Common Serotypes - Serotype 14
|
100 percentage of participants
Interval 97.9 to 100.0
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the Toddler Dose
Common Serotypes - Serotype 18C
|
100 percentage of participants
Interval 97.9 to 100.0
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the Toddler Dose
Common Serotypes - Serotype 19F
|
98.9 percentage of participants
Interval 96.0 to 99.9
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the Toddler Dose
Common Serotypes - Serotype 23F
|
98.9 percentage of participants
Interval 96.0 to 99.9
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the Toddler Dose
Additional Serotypes - Serotype 1
|
100 percentage of participants
Interval 97.9 to 100.0
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the Toddler Dose
Additional Serotypes - Serotype 19A
|
100 percentage of participants
Interval 97.9 to 100.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: one month after the toddler dose (at 12-15 months of age)Population: Evaluable immunogenicity population had valid and determinate assay results, and had no other major protocol violations.
GMC as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
Outcome measures
| Measure |
13vPnC After Infant Series
n=178 Participants
Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 2, 4, 6 months (infant series).
|
13vPnC Dose 2
Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 4 months of age (infant series Dose 2).
|
13vPnC Dose 3
Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 6 months of age (infant series Dose 3).
|
13vPnC Toddler Dose
Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 12-15 months of age (toddler dose).
|
|---|---|---|---|---|
|
Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose
Additional Serotypes - Serotype 1
|
9.85 μg/mL
Interval 8.62 to 11.27
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose
Common Serotypes - Serotype 4
|
9.70 μg/mL
Interval 8.43 to 11.17
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose
Common Serotypes - Serotype 6B
|
14.61 μg/mL
Interval 12.52 to 17.05
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose
Common Serotypes - Serotype 9V
|
4.49 μg/mL
Interval 4.0 to 5.06
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose
Common Serotypes - Serotype 14
|
16.33 μg/mL
Interval 14.49 to 18.41
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose
Common Serotypes - Serotype 18C
|
6.09 μg/mL
Interval 5.34 to 6.95
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose
Common Serotypes - Serotype 19F
|
12.20 μg/mL
Interval 10.37 to 14.35
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose
Common Serotypes - Serotype 23F
|
6.55 μg/mL
Interval 5.53 to 7.75
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose
Additional Serotypes - Serotype 3
|
2.06 μg/mL
Interval 1.83 to 2.32
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose
Additional Serotypes - Serotype 5
|
7.31 μg/mL
Interval 6.52 to 8.2
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose
Additional Serotypes - Serotype 6A
|
11.03 μg/mL
Interval 9.69 to 12.55
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose
Additional Serotypes - Serotype 7F
|
8.31 μg/mL
Interval 7.39 to 9.35
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose
Additional Serotypes - Serotype 19A
|
15.97 μg/mL
Interval 14.07 to 18.13
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Within 7 days after each dosePopulation: The safety population included all participants who received at least 1 dose of vaccine, (n) = number of participants reporting yes for at least 1 day or no for all days.
Local reactions were collected using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters \[cm\] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (\>7.0 cm). Participants may be represented in more than 1 category.
Outcome measures
| Measure |
13vPnC After Infant Series
n=193 Participants
Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 2, 4, 6 months (infant series).
|
13vPnC Dose 2
n=190 Participants
Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 4 months of age (infant series Dose 2).
|
13vPnC Dose 3
n=190 Participants
Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 6 months of age (infant series Dose 3).
|
13vPnC Toddler Dose
n=185 Participants
Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 12-15 months of age (toddler dose).
|
|---|---|---|---|---|
|
Percentage of Participants Reporting Pre-Specified Local Reactions
Tenderness - Any (n=165,156,147,143)
|
13.3 percentage of participants
|
19.9 percentage of participants
|
14.3 percentage of participants
|
18.2 percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions
Tenderness - Significant (n=160,152,143,132)
|
0.6 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
Swelling - Any (n=176,173,165,163)
|
47.2 percentage of participants
|
53.8 percentage of participants
|
53.9 percentage of participants
|
57.1 percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions
Swelling - Mild (n=174,171,163,154)
|
46.0 percentage of participants
|
49.1 percentage of participants
|
50.3 percentage of participants
|
44.2 percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions
Swelling - Moderate (n=167,164,150,151)
|
14.4 percentage of participants
|
28.7 percentage of participants
|
29.3 percentage of participants
|
36.4 percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions
Swelling - Severe (n=160,153,143,132)
|
0.0 percentage of participants
|
1.3 percentage of participants
|
0.7 percentage of participants
|
2.3 percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions
Redness - Any (n=186,180,171,166)
|
74.2 percentage of participants
|
74.4 percentage of participants
|
67.8 percentage of participants
|
68.1 percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions
Redness - Mild (n=183,179,162,156)
|
68.3 percentage of participants
|
64.8 percentage of participants
|
55.6 percentage of participants
|
53.8 percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions
Redness - Moderate (n=170,168,157,155)
|
24.7 percentage of participants
|
43.5 percentage of participants
|
38.9 percentage of participants
|
40.6 percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions
Redness - Severe (n=160,153,143,132)
|
0.0 percentage of participants
|
1.3 percentage of participants
|
0.7 percentage of participants
|
1.5 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Within 7 days after each dosePopulation: The safety population included all subjects who received at least 1 dose of vaccine, (n) = number of participants reporting yes for at least 1 day or no for all days.
Systemic events (fever ≥ 37.5 degrees Celsius \[C\], fever ≥ 38 C but ≤ 39 C, fever \>39 C but ≤ 40 C, fever \> 40 C, decreased appetite, irritability, increased sleep, decreased sleep, hives, use of medication to treat symptoms, and use of medication to prevent symptoms) were reported using an electronic diary. Participants may be represented in more than 1 category.
Outcome measures
| Measure |
13vPnC After Infant Series
n=193 Participants
Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 2, 4, 6 months (infant series).
|
13vPnC Dose 2
n=190 Participants
Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 4 months of age (infant series Dose 2).
|
13vPnC Dose 3
n=190 Participants
Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 6 months of age (infant series Dose 3).
|
13vPnC Toddler Dose
n=185 Participants
Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 12-15 months of age (toddler dose).
|
|---|---|---|---|---|
|
Percentage of Participants Reporting Pre-Specified Systemic Events
Medication to treat symptoms (n=160,153,145,135)
|
1.9 percentage of participants
|
6.5 percentage of participants
|
5.5 percentage of participants
|
8.1 percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events
Fever ≥37.5°C (n=170,163,154,150)
|
32.9 percentage of participants
|
33.1 percentage of participants
|
40.3 percentage of participants
|
50.7 percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events
Fever ≥38°C but ≤39°C (n=163,156,146,137)
|
6.7 percentage of participants
|
12.2 percentage of participants
|
10.3 percentage of participants
|
20.4 percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events
Fever >39°C but ≤40°C (n=161,153,143,133)
|
1.2 percentage of participants
|
2.6 percentage of participants
|
2.8 percentage of participants
|
5.3 percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events
Fever >40°C (n=160,152,143,132)
|
0.0 percentage of participants
|
0.7 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events
Decreased appetite (n=163,158,144,138)
|
11.7 percentage of participants
|
16.5 percentage of participants
|
9.7 percentage of participants
|
18.1 percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events
Irritability (n=170,166,149,140)
|
30.6 percentage of participants
|
36.1 percentage of participants
|
23.5 percentage of participants
|
26.4 percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events
Increased sleep (n=175,160,153,139)
|
40.6 percentage of participants
|
29.4 percentage of participants
|
22.2 percentage of participants
|
24.5 percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events
Decreased sleep (n=169,160,145,138)
|
21.3 percentage of participants
|
23.1 percentage of participants
|
15.9 percentage of participants
|
12.3 percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events
Hives (n=160,152,143,132)
|
1.3 percentage of participants
|
1.3 percentage of participants
|
0.7 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events
Medication to prevent symptoms (n=160,153,144,134)
|
0.6 percentage of participants
|
3.3 percentage of participants
|
2.1 percentage of participants
|
3.0 percentage of participants
|
Adverse Events
13vPnC Infant Series
Serious events: 9 serious events
Other events: 192 other events
Deaths: 0 deaths
13vPnC Post-Infant Series
Serious events: 14 serious events
Other events: 19 other events
Deaths: 0 deaths
13vPnC Toddler Dose
Serious events: 1 serious events
Other events: 171 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
13vPnC Infant Series
n=193 participants at risk
Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 2, 4, 6 months (infant series).
|
13vPnC Post-Infant Series
n=193 participants at risk
Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 2, 4, 6 months (infant series).
|
13vPnC Toddler Dose
n=185 participants at risk
Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 12-15 months (toddler dose).
|
|---|---|---|---|
|
Infections and infestations
Adenovirus infection
|
0.52%
1/193
|
0.00%
0/193
|
0.00%
0/185
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/193
|
0.52%
1/193
|
0.54%
1/185
|
|
Infections and infestations
Bronchiolitis
|
1.0%
2/193
|
0.00%
0/193
|
0.00%
0/185
|
|
Infections and infestations
Bronchitis
|
0.00%
0/193
|
0.52%
1/193
|
0.00%
0/185
|
|
Infections and infestations
Cellulitis staphylococcal
|
0.52%
1/193
|
0.00%
0/193
|
0.00%
0/185
|
|
Infections and infestations
Enteritis infectious
|
0.00%
0/193
|
0.52%
1/193
|
0.00%
0/185
|
|
Infections and infestations
Exanthema subitum
|
0.52%
1/193
|
0.52%
1/193
|
0.00%
0/185
|
|
Nervous system disorders
Febrile convulsion
|
0.00%
0/193
|
1.0%
2/193
|
0.00%
0/185
|
|
Infections and infestations
Gastroenteritis
|
0.52%
1/193
|
0.52%
1/193
|
0.00%
0/185
|
|
Infections and infestations
Pertussis
|
0.00%
0/193
|
1.0%
2/193
|
0.00%
0/185
|
|
Infections and infestations
Pneumonia
|
0.00%
0/193
|
1.0%
2/193
|
0.00%
0/185
|
|
Infections and infestations
Pneumonia respiratory syncytial viral
|
1.0%
2/193
|
0.52%
1/193
|
0.00%
0/185
|
|
Infections and infestations
Respiratory syncytial virus bronchiolitis
|
0.52%
1/193
|
0.00%
0/193
|
0.00%
0/185
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/193
|
0.52%
1/193
|
0.00%
0/185
|
|
Infections and infestations
Rotavirus infection
|
0.00%
0/193
|
0.52%
1/193
|
0.00%
0/185
|
|
Infections and infestations
Staphylococcal sepsis
|
0.52%
1/193
|
0.00%
0/193
|
0.00%
0/185
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/193
|
0.52%
1/193
|
0.00%
0/185
|
|
Infections and infestations
Upper respiratory tract infection
|
0.52%
1/193
|
0.00%
0/193
|
0.00%
0/185
|
|
Infections and infestations
Urinary tract infection
|
0.52%
1/193
|
0.00%
0/193
|
0.00%
0/185
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/193
|
0.52%
1/193
|
0.00%
0/185
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/193
|
0.52%
1/193
|
0.00%
0/185
|
Other adverse events
| Measure |
13vPnC Infant Series
n=193 participants at risk
Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 2, 4, 6 months (infant series).
|
13vPnC Post-Infant Series
n=193 participants at risk
Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 2, 4, 6 months (infant series).
|
13vPnC Toddler Dose
n=185 participants at risk
Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 12-15 months (toddler dose).
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
1.0%
2/193
|
0.00%
0/193
|
0.00%
0/185
|
|
Cardiac disorders
Pulmonary valve stenosis
|
0.52%
1/193
|
0.00%
0/193
|
0.00%
0/185
|
|
Congenital, familial and genetic disorders
Dacryostenosis congenital
|
1.0%
2/193
|
0.00%
0/193
|
0.00%
0/185
|
|
Congenital, familial and genetic disorders
Cryptorchism
|
0.00%
0/193
|
0.52%
1/193
|
0.00%
0/185
|
|
Congenital, familial and genetic disorders
Pectus excavatum
|
0.00%
0/193
|
0.52%
1/193
|
0.00%
0/185
|
|
Ear and labyrinth disorders
Cerumen impaction
|
1.0%
2/193
|
0.00%
0/193
|
1.1%
2/185
|
|
Eye disorders
Conjunctivitis
|
8.3%
16/193
|
0.00%
0/193
|
4.3%
8/185
|
|
Eye disorders
Eye discharge
|
1.6%
3/193
|
0.00%
0/193
|
0.54%
1/185
|
|
Eye disorders
Ocular hyperaemia
|
0.52%
1/193
|
0.00%
0/193
|
0.00%
0/185
|
|
Eye disorders
Keratitis
|
0.00%
0/193
|
0.00%
0/193
|
0.54%
1/185
|
|
Gastrointestinal disorders
Diarrhoea
|
16.6%
32/193
|
0.00%
0/193
|
6.5%
12/185
|
|
Gastrointestinal disorders
Constipation
|
3.6%
7/193
|
0.00%
0/193
|
0.54%
1/185
|
|
Gastrointestinal disorders
Vomiting
|
2.1%
4/193
|
0.52%
1/193
|
1.1%
2/185
|
|
Gastrointestinal disorders
Anal fissure
|
0.52%
1/193
|
0.00%
0/193
|
1.1%
2/185
|
|
Gastrointestinal disorders
Enterocolitis
|
0.52%
1/193
|
0.00%
0/193
|
0.00%
0/185
|
|
Gastrointestinal disorders
Haematochezia
|
0.52%
1/193
|
0.00%
0/193
|
0.00%
0/185
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/193
|
0.00%
0/193
|
0.54%
1/185
|
|
General disorders
Injection site erythema
|
84.5%
163/193
|
0.00%
0/193
|
62.2%
115/185
|
|
General disorders
Injection site swelling
|
62.7%
121/193
|
0.00%
0/193
|
50.8%
94/185
|
|
General disorders
Pyrexia
|
56.0%
108/193
|
0.00%
0/193
|
43.2%
80/185
|
|
General disorders
Irritability
|
23.5%
35/149
|
0.00%
0/193
|
0.00%
0/185
|
|
General disorders
Injection site pain
|
25.4%
49/193
|
0.00%
0/193
|
14.6%
27/185
|
|
General disorders
Injection site induration
|
8.3%
16/193
|
0.00%
0/193
|
1.1%
2/185
|
|
General disorders
Injection site eczema
|
0.00%
0/193
|
0.00%
0/193
|
0.54%
1/185
|
|
General disorders
Injection site mass
|
1.6%
3/193
|
0.00%
0/193
|
0.54%
1/185
|
|
General disorders
Injection site irritation
|
0.52%
1/193
|
0.00%
0/193
|
0.00%
0/185
|
|
General disorders
Injection site warmth
|
0.52%
1/193
|
0.00%
0/193
|
0.00%
0/185
|
|
General disorders
Swelling
|
0.52%
1/193
|
0.00%
0/193
|
0.00%
0/185
|
|
General disorders
Vaccination site induration
|
0.52%
1/193
|
0.00%
0/193
|
0.00%
0/185
|
|
General disorders
Vessel puncture site reaction
|
0.52%
1/193
|
0.00%
0/193
|
0.00%
0/185
|
|
Hepatobiliary disorders
Liver disorder
|
0.52%
1/193
|
0.00%
0/193
|
0.00%
0/185
|
|
Immune system disorders
Food allergy
|
1.6%
3/193
|
4.1%
8/193
|
0.00%
0/185
|
|
Immune system disorders
Milk allergy
|
0.52%
1/193
|
0.00%
0/193
|
0.00%
0/185
|
|
Immune system disorders
Solvent sensitivity
|
0.52%
1/193
|
0.00%
0/193
|
0.00%
0/185
|
|
Infections and infestations
Upper respiratory tract infection
|
39.9%
77/193
|
0.00%
0/193
|
22.7%
42/185
|
|
Infections and infestations
Nasopharyngitis
|
21.2%
41/193
|
0.00%
0/193
|
8.1%
15/185
|
|
Infections and infestations
Bronchitis
|
12.4%
24/193
|
0.52%
1/193
|
6.5%
12/185
|
|
Infections and infestations
Exanthema subitum
|
12.4%
24/193
|
0.00%
0/193
|
3.8%
7/185
|
|
Infections and infestations
Gastroenteritis
|
9.8%
19/193
|
0.00%
0/193
|
2.7%
5/185
|
|
Infections and infestations
Influenza
|
4.7%
9/193
|
0.00%
0/193
|
0.54%
1/185
|
|
Infections and infestations
Pharyngitis
|
4.7%
9/193
|
0.00%
0/193
|
4.3%
8/185
|
|
Infections and infestations
Varicella
|
4.7%
9/193
|
0.00%
0/193
|
0.54%
1/185
|
|
Infections and infestations
Rhinitis
|
3.6%
7/193
|
0.00%
0/193
|
1.6%
3/185
|
|
Infections and infestations
Enteritis infectious
|
2.6%
5/193
|
0.00%
0/193
|
0.54%
1/185
|
|
Infections and infestations
Otitis media
|
2.6%
5/193
|
0.52%
1/193
|
5.4%
10/185
|
|
Infections and infestations
Otitis media acute
|
2.6%
5/193
|
0.00%
0/193
|
2.2%
4/185
|
|
Infections and infestations
Bronchiolitis
|
2.1%
4/193
|
0.00%
0/193
|
0.54%
1/185
|
|
Infections and infestations
Croup infectious
|
2.1%
4/193
|
0.00%
0/193
|
0.00%
0/185
|
|
Infections and infestations
Gastroenteritis viral
|
2.1%
4/193
|
0.00%
0/193
|
2.2%
4/185
|
|
Infections and infestations
Molluscum contagiosum
|
2.1%
4/193
|
0.00%
0/193
|
0.54%
1/185
|
|
Infections and infestations
Adenovirus infection
|
1.6%
3/193
|
0.00%
0/193
|
0.54%
1/185
|
|
Infections and infestations
Respiratory syncytial virus infection
|
1.6%
3/193
|
0.00%
0/193
|
0.00%
0/185
|
|
Infections and infestations
Conjunctivitis bacterial
|
1.0%
2/193
|
0.00%
0/193
|
0.00%
0/185
|
|
Infections and infestations
Fungal skin infection
|
1.0%
2/193
|
0.00%
0/193
|
0.00%
0/185
|
|
Infections and infestations
Gastroenteritis rotavirus
|
1.0%
2/193
|
0.00%
0/193
|
0.00%
0/185
|
|
Infections and infestations
Respiratory tract infection
|
1.0%
2/193
|
0.00%
0/193
|
0.00%
0/185
|
|
Infections and infestations
Skin candida
|
1.0%
2/193
|
0.00%
0/193
|
0.00%
0/185
|
|
Infections and infestations
Viral rash
|
1.0%
2/193
|
0.00%
0/193
|
0.00%
0/185
|
|
Infections and infestations
Cellulitis
|
0.52%
1/193
|
0.00%
0/193
|
0.00%
0/185
|
|
Infections and infestations
Enterocolitis viral
|
0.52%
1/193
|
0.00%
0/193
|
0.00%
0/185
|
|
Infections and infestations
Enterovirus infection
|
0.52%
1/193
|
0.00%
0/193
|
0.00%
0/185
|
|
Infections and infestations
Herpes simplex
|
0.52%
1/193
|
0.00%
0/193
|
0.00%
0/185
|
|
Infections and infestations
Impetigo
|
0.52%
1/193
|
0.00%
0/193
|
1.1%
2/185
|
|
Infections and infestations
Laryngitis
|
0.52%
1/193
|
0.00%
0/193
|
0.00%
0/185
|
|
Infections and infestations
Omphalitis
|
0.52%
1/193
|
0.00%
0/193
|
0.00%
0/185
|
|
Infections and infestations
Oral candidiasis
|
0.52%
1/193
|
0.00%
0/193
|
0.00%
0/185
|
|
Infections and infestations
Paronychia
|
0.52%
1/193
|
0.00%
0/193
|
0.00%
0/185
|
|
Infections and infestations
Pertussis
|
0.52%
1/193
|
0.00%
0/193
|
0.00%
0/185
|
|
Infections and infestations
Pneumonia respiratory syncytial viral
|
0.52%
1/193
|
0.00%
0/193
|
0.00%
0/185
|
|
Infections and infestations
Respiratory syncytial virus bronchiolitis
|
0.52%
1/193
|
0.00%
0/193
|
0.00%
0/185
|
|
Infections and infestations
Rotavirus infection
|
0.52%
1/193
|
0.00%
0/193
|
0.00%
0/185
|
|
Infections and infestations
Subcutaneous abscess
|
0.52%
1/193
|
0.00%
0/193
|
0.00%
0/185
|
|
Infections and infestations
Viral diarrhoea
|
0.52%
1/193
|
0.00%
0/193
|
0.00%
0/185
|
|
Infections and infestations
Viral infection
|
0.52%
1/193
|
0.00%
0/193
|
0.54%
1/185
|
|
Infections and infestations
Herpangina
|
0.00%
0/193
|
0.00%
0/193
|
2.2%
4/185
|
|
Infections and infestations
Adenoviral upper respiratory infection
|
0.00%
0/193
|
0.00%
0/193
|
0.54%
1/185
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/193
|
0.00%
0/193
|
0.54%
1/185
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/193
|
0.00%
0/193
|
0.54%
1/185
|
|
Infections and infestations
Gastroenteritis bacterial
|
0.00%
0/193
|
0.00%
0/193
|
0.54%
1/185
|
|
Infections and infestations
Sinusitis
|
0.00%
0/193
|
0.00%
0/193
|
0.54%
1/185
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/193
|
0.00%
0/193
|
0.54%
1/185
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
1.6%
3/193
|
0.00%
0/193
|
1.6%
3/185
|
|
Injury, poisoning and procedural complications
Contusion
|
1.0%
2/193
|
0.00%
0/193
|
0.00%
0/185
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.52%
1/193
|
0.00%
0/193
|
0.00%
0/185
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.52%
1/193
|
0.00%
0/193
|
0.54%
1/185
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.52%
1/193
|
0.00%
0/193
|
0.00%
0/185
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.52%
1/193
|
0.00%
0/193
|
0.54%
1/185
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.52%
1/193
|
0.00%
0/193
|
1.1%
2/185
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.52%
1/193
|
0.00%
0/193
|
0.00%
0/185
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/193
|
0.00%
0/193
|
0.54%
1/185
|
|
Injury, poisoning and procedural complications
Mouth injury
|
0.00%
0/193
|
0.00%
0/193
|
0.54%
1/185
|
|
Investigations
Liver function test abnormal
|
0.52%
1/193
|
0.00%
0/193
|
0.00%
0/185
|
|
Metabolism and nutrition disorders
Decreased appetite
|
24.4%
47/193
|
0.00%
0/193
|
13.5%
25/185
|
|
Metabolism and nutrition disorders
Dehydration
|
1.0%
2/193
|
0.00%
0/193
|
0.00%
0/185
|
|
Metabolism and nutrition disorders
Lactose intolerance
|
1.0%
2/193
|
0.52%
1/193
|
0.00%
0/185
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/193
|
0.00%
0/193
|
0.54%
1/185
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphangioma
|
0.00%
0/193
|
0.52%
1/193
|
0.00%
0/185
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibroma
|
0.00%
0/193
|
0.00%
0/193
|
0.54%
1/185
|
|
Nervous system disorders
Hypersomnia
|
52.3%
101/193
|
0.00%
0/193
|
18.4%
34/185
|
|
Nervous system disorders
Crying
|
1.0%
2/193
|
0.00%
0/193
|
0.00%
0/185
|
|
Psychiatric disorders
Insomnia
|
34.2%
66/193
|
0.00%
0/193
|
9.2%
17/185
|
|
Psychiatric disorders
Head banging
|
0.52%
1/193
|
0.00%
0/193
|
0.00%
0/185
|
|
Renal and urinary disorders
Vesicoureteric reflux
|
0.52%
1/193
|
0.00%
0/193
|
0.00%
0/185
|
|
Reproductive system and breast disorders
Balanoposthitis
|
0.52%
1/193
|
0.00%
0/193
|
0.00%
0/185
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
6.7%
13/193
|
0.00%
0/193
|
4.3%
8/185
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
5.7%
11/193
|
2.1%
4/193
|
3.8%
7/185
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
4.1%
8/193
|
0.00%
0/193
|
0.54%
1/185
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.1%
4/193
|
0.00%
0/193
|
0.54%
1/185
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.52%
1/193
|
0.00%
0/193
|
0.00%
0/185
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.52%
1/193
|
0.00%
0/193
|
0.00%
0/185
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.52%
1/193
|
0.00%
0/193
|
0.00%
0/185
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.52%
1/193
|
0.00%
0/193
|
0.00%
0/185
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/193
|
0.00%
0/193
|
0.54%
1/185
|
|
Respiratory, thoracic and mediastinal disorders
Fibrinous bronchitis
|
0.00%
0/193
|
0.00%
0/193
|
0.54%
1/185
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
14.0%
27/193
|
0.00%
0/193
|
2.2%
4/185
|
|
Skin and subcutaneous tissue disorders
Eczema
|
12.4%
24/193
|
0.00%
0/193
|
5.4%
10/185
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.3%
14/193
|
0.00%
0/193
|
0.54%
1/185
|
|
Skin and subcutaneous tissue disorders
Eczema infantile
|
4.1%
8/193
|
0.00%
0/193
|
0.54%
1/185
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
3.6%
7/193
|
0.00%
0/193
|
2.2%
4/185
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
3.1%
6/193
|
0.00%
0/193
|
0.00%
0/185
|
|
Skin and subcutaneous tissue disorders
Erythema
|
3.1%
6/193
|
0.00%
0/193
|
0.00%
0/185
|
|
Skin and subcutaneous tissue disorders
Heat rash
|
3.1%
6/193
|
0.00%
0/193
|
4.3%
8/185
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
2.1%
4/193
|
0.00%
0/193
|
0.00%
0/185
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
1.6%
3/193
|
1.0%
2/193
|
0.00%
0/185
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
1.0%
2/193
|
0.00%
0/193
|
0.00%
0/185
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
1.0%
2/193
|
0.00%
0/193
|
0.00%
0/185
|
|
Skin and subcutaneous tissue disorders
Asteatosis
|
0.52%
1/193
|
0.00%
0/193
|
0.00%
0/185
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.52%
1/193
|
0.00%
0/193
|
0.00%
0/185
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.52%
1/193
|
0.00%
0/193
|
0.00%
0/185
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.52%
1/193
|
0.00%
0/193
|
0.00%
0/185
|
|
Skin and subcutaneous tissue disorders
Eczema asteatotic
|
0.52%
1/193
|
0.00%
0/193
|
0.54%
1/185
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.52%
1/193
|
0.00%
0/193
|
0.54%
1/185
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.52%
1/193
|
0.00%
0/193
|
0.00%
0/185
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.52%
1/193
|
0.00%
0/193
|
0.00%
0/185
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/193
|
0.00%
0/193
|
0.54%
1/185
|
|
Skin and subcutaneous tissue disorders
Tenderness (Any)
|
14.3%
21/147
|
0.00%
0/193
|
0.00%
0/185
|
|
Skin and subcutaneous tissue disorders
Tenderness (Significant)
|
0.00%
0/143
|
0.00%
0/193
|
0.00%
0/185
|
|
Skin and subcutaneous tissue disorders
Induration (Any)
|
53.9%
89/165
|
0.00%
0/193
|
0.00%
0/185
|
|
Skin and subcutaneous tissue disorders
Induration(Mild)
|
50.3%
82/163
|
0.00%
0/193
|
0.00%
0/185
|
|
Skin and subcutaneous tissue disorders
Induration (Moderate)
|
29.3%
44/150
|
0.00%
0/193
|
0.00%
0/185
|
|
Skin and subcutaneous tissue disorders
Induration (Severe)
|
0.70%
1/143
|
0.00%
0/193
|
0.00%
0/185
|
|
Skin and subcutaneous tissue disorders
Erythema (Any)
|
67.8%
116/171
|
0.00%
0/193
|
0.00%
0/185
|
|
Skin and subcutaneous tissue disorders
Erythema (Mild)
|
55.6%
90/162
|
0.00%
0/193
|
0.00%
0/185
|
|
Skin and subcutaneous tissue disorders
Erythema (Moderate)
|
38.9%
61/157
|
0.00%
0/193
|
0.00%
0/185
|
|
Skin and subcutaneous tissue disorders
Erythema (Severe)
|
0.70%
1/143
|
0.00%
0/193
|
0.00%
0/185
|
|
General disorders
Any fever (≥37.5°C)
|
40.3%
62/154
|
0.00%
0/193
|
0.00%
0/185
|
|
General disorders
Fever ≥38°C but ≤39°C (mild)
|
10.3%
15/146
|
0.00%
0/193
|
0.00%
0/185
|
|
General disorders
Fever >39°C but ≤40°C (moderate)
|
2.8%
4/143
|
0.00%
0/193
|
0.00%
0/185
|
|
General disorders
Fever >40°C (severe)
|
0.00%
0/143
|
0.00%
0/193
|
0.00%
0/185
|
|
General disorders
Decreased appetite
|
9.7%
14/144
|
0.00%
0/193
|
0.00%
0/185
|
|
General disorders
Increased sleep
|
22.2%
34/153
|
0.00%
0/193
|
0.00%
0/185
|
|
General disorders
Decreased sleep
|
15.9%
23/145
|
0.00%
0/193
|
0.00%
0/185
|
|
General disorders
Hives (urticaria)
|
0.70%
1/143
|
0.00%
0/193
|
0.00%
0/185
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The PIs agreed to allow the sponsor 60 days to review and require changes to presentations or publications but only to protect confidential information and intellectual property, and for the sponsor to file a patent application, as applicable. The PIs also agreed for data to be presented first as a joint, multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER