Trial Outcomes & Findings for Safety, Tolerability and Immunogenicity of V114 in Healthy Adults and Infants (V114-004) (NCT NCT02037984)
NCT ID: NCT02037984
Last Updated: 2019-06-24
Results Overview
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
341 participants
Primary outcome timeframe
Up to 14 days
Results posted on
2019-06-24
Participant Flow
Healthy adults and infants were recruited and enrolled at 26 study sites in the United States. Each of the adult participants completed the study prior to enrollment of the infant participants.
Participant milestones
| Measure |
Adult V114: 1x:1x:1x
On Day 1, adults receive a single vaccination of V114 1x:1x:1x (containing 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 4.0 μg of polysaccharide serotype 6B; and 125 µg of Aluminum Phosphate Adjuvant \[APA\]).
|
Adult V114: 2x.2x.2x
On Day 1, adults receive a single vaccination of V114 2x:2x:2x (containing 4.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 8.0 μg of polysaccharide serotype 6B; and 250 µg of APA).
|
Infant V114: 1x:1x:1x
Infants receive 4 total V114: 1x:1x:1x (containing 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 4.0 μg of polysaccharide serotype 6B; and 125 µg of APA) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
Infant V114: 2x:1x:2x
Infants receive 4 total V114: 2x:1x:2x (containing 4.0 μg of polysaccharide serotypes 6A, 18C, 19A, 19F, and 23F; 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 7F, 9V, 14, 22F, and 33F; 8.0 μg of polysaccharide serotype 6B; and 250 µg of APA) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
Infant V114: 2x:2x:2x
Infants receive 4 total V114: 2x:2x:2x (containing 4.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 8.0 μg of polysaccharide serotype 6B; and 250 µg of APA) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
Infant V114: 0.5x:0.5x:2x
Infants receive 4 total V114 0.5x:0.5x:2x (containing 1.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 2.0 μg of polysaccharide serotype 6B; and 250 µg of APA) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
Infant V114: 1x:1x:2x
Infants receive 4 total V114 1x:1x:2x (containing 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 4.0 μg of polysaccharide serotype 6B; and 250 µg of APA) total vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
Infant Prevnar 13®
Infants receive 4 total Prevnar 13® (containing 2.2 µg of pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, and 23F; and 4.4 µg of serotype 6B) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
50
|
51
|
50
|
49
|
50
|
51
|
|
Overall Study
COMPLETED
|
19
|
20
|
38
|
30
|
38
|
37
|
33
|
39
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
12
|
21
|
12
|
12
|
17
|
12
|
Reasons for withdrawal
| Measure |
Adult V114: 1x:1x:1x
On Day 1, adults receive a single vaccination of V114 1x:1x:1x (containing 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 4.0 μg of polysaccharide serotype 6B; and 125 µg of Aluminum Phosphate Adjuvant \[APA\]).
|
Adult V114: 2x.2x.2x
On Day 1, adults receive a single vaccination of V114 2x:2x:2x (containing 4.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 8.0 μg of polysaccharide serotype 6B; and 250 µg of APA).
|
Infant V114: 1x:1x:1x
Infants receive 4 total V114: 1x:1x:1x (containing 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 4.0 μg of polysaccharide serotype 6B; and 125 µg of APA) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
Infant V114: 2x:1x:2x
Infants receive 4 total V114: 2x:1x:2x (containing 4.0 μg of polysaccharide serotypes 6A, 18C, 19A, 19F, and 23F; 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 7F, 9V, 14, 22F, and 33F; 8.0 μg of polysaccharide serotype 6B; and 250 µg of APA) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
Infant V114: 2x:2x:2x
Infants receive 4 total V114: 2x:2x:2x (containing 4.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 8.0 μg of polysaccharide serotype 6B; and 250 µg of APA) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
Infant V114: 0.5x:0.5x:2x
Infants receive 4 total V114 0.5x:0.5x:2x (containing 1.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 2.0 μg of polysaccharide serotype 6B; and 250 µg of APA) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
Infant V114: 1x:1x:2x
Infants receive 4 total V114 1x:1x:2x (containing 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 4.0 μg of polysaccharide serotype 6B; and 250 µg of APA) total vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
Infant Prevnar 13®
Infants receive 4 total Prevnar 13® (containing 2.2 µg of pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, and 23F; and 4.4 µg of serotype 6B) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
3
|
10
|
2
|
2
|
4
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
3
|
5
|
2
|
2
|
2
|
4
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
0
|
0
|
1
|
2
|
0
|
|
Overall Study
Technical Problems
|
0
|
0
|
3
|
3
|
2
|
3
|
4
|
2
|
|
Overall Study
Withdrawal by Parent/Guardian
|
0
|
0
|
3
|
2
|
5
|
1
|
4
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
1
|
3
|
0
|
1
|
Baseline Characteristics
Adult participants only are included.
Baseline characteristics by cohort
| Measure |
Adult V114: 1x:1x:1x
n=20 Participants
On Day 1, adults receive a single vaccination of V114 1x:1x:1x (containing 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 4.0 μg of polysaccharide serotype 6B; and 125 µg of APA).
|
Adult V114: 2x.2x.2x
n=20 Participants
On Day 1, adults receive a single vaccination of V114 2x:2x:2x (containing 4.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 8.0 μg of polysaccharide serotype 6B; and 250 µg of APA).
|
Infant V114: 1x:1x:1x
n=50 Participants
Infants receive 4 total V114: 1x:1x:1x (containing 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 4.0 μg of polysaccharide serotype 6B; and 125 µg of APA) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
Infant V114: 2x:1x:2x
n=51 Participants
Infants receive 4 total V114: 2x:1x:2x (containing 4.0 μg of polysaccharide serotypes 6A, 18C, 19A, 19F, and 23F; 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 7F, 9V, 14, 22F, and 33F; 8.0 μg of polysaccharide serotype 6B; and 250 µg of APA) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
Infant V114: 2x:2x:2x
n=50 Participants
Infants receive 4 total V114: 2x:2x:2x (containing 4.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 8.0 μg of polysaccharide serotype 6B; and 250 µg of APA) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
Infant V114: 0.5x:0.5x:2x
n=48 Participants
Infants receive 4 total V114 0.5x:0.5x:2x (containing 1.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 2.0 μg of polysaccharide serotype 6B; and 250 µg of APA) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
Infant V114: 1x:1x:2x
n=50 Participants
Infants receive 4 total V114 1x:1x:2x (containing 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 4.0 μg of polysaccharide serotype 6B; and 250 µg of APA) total vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
Infant Prevnar 13®
n=51 Participants
Infants receive 4 total Prevnar 13® (containing 2.2 µg of pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, and 23F; and 4.4 µg of serotype 6B) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
Total
n=340 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
31.3 Years
STANDARD_DEVIATION 8.9 • n=20 Participants • Adult participants only are included.
|
31.6 Years
STANDARD_DEVIATION 8.1 • n=20 Participants • Adult participants only are included.
|
8.9 Weeks
STANDARD_DEVIATION 1.4 • n=50 Participants • Infant participants only are included.
|
8.7 Weeks
STANDARD_DEVIATION 1.2 • n=51 Participants • Infant participants only are included.
|
8.9 Weeks
STANDARD_DEVIATION 1.3 • n=50 Participants • Infant participants only are included.
|
8.5 Weeks
STANDARD_DEVIATION 1.5 • n=48 Participants • Infant participants only are included.
|
8.6 Weeks
STANDARD_DEVIATION 1.0 • n=50 Participants • Infant participants only are included.
|
8.4 Weeks
STANDARD_DEVIATION 1.0 • n=51 Participants • Infant participants only are included.
|
8.7 Weeks
STANDARD_DEVIATION 1.2 • n=300 Participants • Infant participants only are included.
|
|
Sex: Female, Male
Female
|
15 Participants
n=20 Participants
|
12 Participants
n=20 Participants
|
30 Participants
n=50 Participants
|
26 Participants
n=51 Participants
|
23 Participants
n=50 Participants
|
18 Participants
n=48 Participants
|
28 Participants
n=50 Participants
|
30 Participants
n=51 Participants
|
182 Participants
n=340 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=20 Participants
|
8 Participants
n=20 Participants
|
20 Participants
n=50 Participants
|
25 Participants
n=51 Participants
|
27 Participants
n=50 Participants
|
30 Participants
n=48 Participants
|
22 Participants
n=50 Participants
|
21 Participants
n=51 Participants
|
158 Participants
n=340 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=51 Participants
|
1 Participants
n=340 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=51 Participants
|
1 Participants
n=340 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=50 Participants
|
0 Participants
n=51 Participants
|
1 Participants
n=50 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=51 Participants
|
2 Participants
n=340 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
3 Participants
n=50 Participants
|
5 Participants
n=51 Participants
|
4 Participants
n=50 Participants
|
8 Participants
n=48 Participants
|
2 Participants
n=50 Participants
|
4 Participants
n=51 Participants
|
33 Participants
n=340 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=20 Participants
|
15 Participants
n=20 Participants
|
42 Participants
n=50 Participants
|
44 Participants
n=51 Participants
|
41 Participants
n=50 Participants
|
35 Participants
n=48 Participants
|
46 Participants
n=50 Participants
|
42 Participants
n=51 Participants
|
280 Participants
n=340 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
4 Participants
n=50 Participants
|
2 Participants
n=51 Participants
|
4 Participants
n=50 Participants
|
5 Participants
n=48 Participants
|
2 Participants
n=50 Participants
|
5 Participants
n=51 Participants
|
23 Participants
n=340 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=340 Participants
|
PRIMARY outcome
Timeframe: Up to 14 daysPopulation: Adult participants who received V114 are included.
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Outcome measures
| Measure |
Adult V114: 1x:1x:1x
n=20 Participants
On Day 1, adults receive a single vaccination of V114 1x:1x:1x (containing 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 4.0 μg of polysaccharide serotype 6B; and 125 µg of APA).
|
Adult V114: 2x.2x.2x
n=20 Participants
On Day 1, adults receive a single vaccination of V114 2x:2x:2x (containing 4.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 8.0 μg of polysaccharide serotype 6B; and 250 µg of APA).
|
Infant V114: 2x:2x:2x
Infants receive 4 total V114: 2x:2x:2x (containing 4.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 8.0 μg of polysaccharide serotype 6B; and 250 µg of APA) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
Infant V114: 0.5x:0.5x:2x
Infants receive 4 total V114 0.5x:0.5x:2x (containing 1.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 2.0 μg of polysaccharide serotype 6B; and 250 µg of APA) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
Infant V114: 1x:1x:2x
Infants receive 4 total V114 1x:1x:2x (containing 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 4.0 μg of polysaccharide serotype 6B; and 250 µg of APA) total vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
Infant Prevnar 13®
Infants receive 4 total Prevnar 13® (containing 2.2 µg of pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, and 23F; and 4.4 µg of serotype 6B) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
|---|---|---|---|---|---|---|
|
Percentage of Adult Participants Experiencing ≥1 Adverse Event (AE)
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 14 daysPopulation: Adult participants who received V114 are included.
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Outcome measures
| Measure |
Adult V114: 1x:1x:1x
n=20 Participants
On Day 1, adults receive a single vaccination of V114 1x:1x:1x (containing 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 4.0 μg of polysaccharide serotype 6B; and 125 µg of APA).
|
Adult V114: 2x.2x.2x
n=20 Participants
On Day 1, adults receive a single vaccination of V114 2x:2x:2x (containing 4.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 8.0 μg of polysaccharide serotype 6B; and 250 µg of APA).
|
Infant V114: 2x:2x:2x
Infants receive 4 total V114: 2x:2x:2x (containing 4.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 8.0 μg of polysaccharide serotype 6B; and 250 µg of APA) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
Infant V114: 0.5x:0.5x:2x
Infants receive 4 total V114 0.5x:0.5x:2x (containing 1.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 2.0 μg of polysaccharide serotype 6B; and 250 µg of APA) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
Infant V114: 1x:1x:2x
Infants receive 4 total V114 1x:1x:2x (containing 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 4.0 μg of polysaccharide serotype 6B; and 250 µg of APA) total vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
Infant Prevnar 13®
Infants receive 4 total Prevnar 13® (containing 2.2 µg of pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, and 23F; and 4.4 µg of serotype 6B) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
|---|---|---|---|---|---|---|
|
Percentage of Adult Participants Discontinuing From Study Treatment Due to an Adverse Event (AE)
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 14 days after the 4th vaccination (approximately 12.5 to 15.5 months of age)Population: Infant participants who received V114 are included.
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. For infants, AEs were monitored for up to 14 days following each vaccination.
Outcome measures
| Measure |
Adult V114: 1x:1x:1x
n=50 Participants
On Day 1, adults receive a single vaccination of V114 1x:1x:1x (containing 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 4.0 μg of polysaccharide serotype 6B; and 125 µg of APA).
|
Adult V114: 2x.2x.2x
n=51 Participants
On Day 1, adults receive a single vaccination of V114 2x:2x:2x (containing 4.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 8.0 μg of polysaccharide serotype 6B; and 250 µg of APA).
|
Infant V114: 2x:2x:2x
n=50 Participants
Infants receive 4 total V114: 2x:2x:2x (containing 4.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 8.0 μg of polysaccharide serotype 6B; and 250 µg of APA) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
Infant V114: 0.5x:0.5x:2x
n=48 Participants
Infants receive 4 total V114 0.5x:0.5x:2x (containing 1.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 2.0 μg of polysaccharide serotype 6B; and 250 µg of APA) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
Infant V114: 1x:1x:2x
n=50 Participants
Infants receive 4 total V114 1x:1x:2x (containing 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 4.0 μg of polysaccharide serotype 6B; and 250 µg of APA) total vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
Infant Prevnar 13®
n=51 Participants
Infants receive 4 total Prevnar 13® (containing 2.2 µg of pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, and 23F; and 4.4 µg of serotype 6B) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
|---|---|---|---|---|---|---|
|
Percentage of Infant Participants Experiencing ≥1 Adverse Event (AE)
|
98.0 Percentage of Participants
|
100.0 Percentage of Participants
|
96.0 Percentage of Participants
|
97.9 Percentage of Participants
|
98.0 Percentage of Participants
|
98.0 Percentage of Participants
|
PRIMARY outcome
Timeframe: Up to 14 days after the 4th vaccination (approximately 12.5 to 15.5 months of age)Population: Infant participants who received V114 are included.
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. For infants, AEs were monitored for up to 14 days following each vaccination.
Outcome measures
| Measure |
Adult V114: 1x:1x:1x
n=50 Participants
On Day 1, adults receive a single vaccination of V114 1x:1x:1x (containing 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 4.0 μg of polysaccharide serotype 6B; and 125 µg of APA).
|
Adult V114: 2x.2x.2x
n=51 Participants
On Day 1, adults receive a single vaccination of V114 2x:2x:2x (containing 4.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 8.0 μg of polysaccharide serotype 6B; and 250 µg of APA).
|
Infant V114: 2x:2x:2x
n=50 Participants
Infants receive 4 total V114: 2x:2x:2x (containing 4.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 8.0 μg of polysaccharide serotype 6B; and 250 µg of APA) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
Infant V114: 0.5x:0.5x:2x
n=48 Participants
Infants receive 4 total V114 0.5x:0.5x:2x (containing 1.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 2.0 μg of polysaccharide serotype 6B; and 250 µg of APA) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
Infant V114: 1x:1x:2x
n=50 Participants
Infants receive 4 total V114 1x:1x:2x (containing 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 4.0 μg of polysaccharide serotype 6B; and 250 µg of APA) total vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
Infant Prevnar 13®
n=51 Participants
Infants receive 4 total Prevnar 13® (containing 2.2 µg of pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, and 23F; and 4.4 µg of serotype 6B) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
|---|---|---|---|---|---|---|
|
Percentage of Infant Participants Discontinuing From Study Treatment Due to an Adverse Event (AE)
|
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: Month 7 (1 month PD3)Population: Randomized and treated infants with results available for the outcome measure and no protocol violations are included.
The IgG antibody GMCs of each Prevnar 13®-type (PT) or non-Prevnar 13® type (non-PT) serotype at 1 month PD3 following V114 or Prevnar 13® treatment were determined with the pneumococcal electrochemiluminescence (Pn ECL) assay. Data reflect the GMC of each serotype.
Outcome measures
| Measure |
Adult V114: 1x:1x:1x
n=50 Participants
On Day 1, adults receive a single vaccination of V114 1x:1x:1x (containing 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 4.0 μg of polysaccharide serotype 6B; and 125 µg of APA).
|
Adult V114: 2x.2x.2x
n=51 Participants
On Day 1, adults receive a single vaccination of V114 2x:2x:2x (containing 4.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 8.0 μg of polysaccharide serotype 6B; and 250 µg of APA).
|
Infant V114: 2x:2x:2x
Infants receive 4 total V114: 2x:2x:2x (containing 4.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 8.0 μg of polysaccharide serotype 6B; and 250 µg of APA) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
Infant V114: 0.5x:0.5x:2x
Infants receive 4 total V114 0.5x:0.5x:2x (containing 1.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 2.0 μg of polysaccharide serotype 6B; and 250 µg of APA) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
Infant V114: 1x:1x:2x
Infants receive 4 total V114 1x:1x:2x (containing 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 4.0 μg of polysaccharide serotype 6B; and 250 µg of APA) total vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
Infant Prevnar 13®
Infants receive 4 total Prevnar 13® (containing 2.2 µg of pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, and 23F; and 4.4 µg of serotype 6B) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
|---|---|---|---|---|---|---|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 1x:1x:1x vs. Prevnar 13®
PT3
|
0.96 µg/mL
Interval 0.75 to 1.22
|
0.43 µg/mL
Interval 0.35 to 0.54
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 1x:1x:1x vs. Prevnar 13®
PT4
|
1.33 µg/mL
Interval 1.07 to 1.66
|
0.98 µg/mL
Interval 0.78 to 1.22
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 1x:1x:1x vs. Prevnar 13®
PT19F
|
2.31 µg/mL
Interval 1.75 to 3.04
|
1.89 µg/mL
Interval 1.56 to 2.3
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 1x:1x:1x vs. Prevnar 13®
PT23F
|
1.02 µg/mL
Interval 0.75 to 1.4
|
1.13 µg/mL
Interval 0.87 to 1.47
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 1x:1x:1x vs. Prevnar 13®
PT1
|
1.20 µg/mL
Interval 0.98 to 1.48
|
1.48 µg/mL
Interval 1.2 to 1.83
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 1x:1x:1x vs. Prevnar 13®
PT5
|
1.16 µg/mL
Interval 0.88 to 1.53
|
1.63 µg/mL
Interval 1.25 to 2.14
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 1x:1x:1x vs. Prevnar 13®
PT6A
|
1.64 µg/mL
Interval 1.04 to 2.61
|
2.75 µg/mL
Interval 2.28 to 3.31
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 1x:1x:1x vs. Prevnar 13®
PT6B
|
0.77 µg/mL
Interval 0.45 to 1.32
|
2.24 µg/mL
Interval 1.54 to 3.24
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 1x:1x:1x vs. Prevnar 13®
PT7F
|
2.09 µg/mL
Interval 1.65 to 2.64
|
2.90 µg/mL
Interval 2.48 to 3.39
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 1x:1x:1x vs. Prevnar 13®
PT9V
|
1.00 µg/mL
Interval 0.75 to 1.33
|
1.35 µg/mL
Interval 1.05 to 1.74
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 1x:1x:1x vs. Prevnar 13®
PT14
|
2.96 µg/mL
Interval 1.95 to 4.48
|
5.01 µg/mL
Interval 3.94 to 6.38
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 1x:1x:1x vs. Prevnar 13®
PT18C
|
1.29 µg/mL
Interval 1.05 to 1.6
|
1.41 µg/mL
Interval 1.14 to 1.74
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 1x:1x:1x vs. Prevnar 13®
PT19A
|
1.27 µg/mL
Interval 0.99 to 1.62
|
1.45 µg/mL
Interval 1.13 to 1.86
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 1x:1x:1x vs. Prevnar 13®
non-PT22F
|
4.10 µg/mL
Interval 3.04 to 5.53
|
0.06 µg/mL
Interval 0.05 to 0.08
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 1x:1x:1x vs. Prevnar 13®
non-PT33F
|
1.37 µg/mL
Interval 0.84 to 2.22
|
0.06 µg/mL
Interval 0.04 to 0.08
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Month 7 (1 month PD3)Population: Randomized and treated infants with results available for the outcome measure and no protocol violations are included.
The IgG antibody GMCs of each Prevnar 13®-type (PT) or non-Prevnar 13® type (non-PT) serotype at 1 month PD3 following V114 or Prevnar 13® treatment were determined with the pneumococcal electrochemiluminescence (Pn ECL) assay. Data reflect the GMC of each serotype.
Outcome measures
| Measure |
Adult V114: 1x:1x:1x
n=51 Participants
On Day 1, adults receive a single vaccination of V114 1x:1x:1x (containing 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 4.0 μg of polysaccharide serotype 6B; and 125 µg of APA).
|
Adult V114: 2x.2x.2x
n=51 Participants
On Day 1, adults receive a single vaccination of V114 2x:2x:2x (containing 4.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 8.0 μg of polysaccharide serotype 6B; and 250 µg of APA).
|
Infant V114: 2x:2x:2x
Infants receive 4 total V114: 2x:2x:2x (containing 4.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 8.0 μg of polysaccharide serotype 6B; and 250 µg of APA) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
Infant V114: 0.5x:0.5x:2x
Infants receive 4 total V114 0.5x:0.5x:2x (containing 1.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 2.0 μg of polysaccharide serotype 6B; and 250 µg of APA) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
Infant V114: 1x:1x:2x
Infants receive 4 total V114 1x:1x:2x (containing 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 4.0 μg of polysaccharide serotype 6B; and 250 µg of APA) total vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
Infant Prevnar 13®
Infants receive 4 total Prevnar 13® (containing 2.2 µg of pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, and 23F; and 4.4 µg of serotype 6B) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
|---|---|---|---|---|---|---|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 2x:1x:2x vs. Prevnar 13®
PT3
|
0.77 µg/mL
Interval 0.6 to 0.99
|
0.43 µg/mL
Interval 0.35 to 0.54
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 2x:1x:2x vs. Prevnar 13®
PT4
|
0.85 µg/mL
Interval 0.7 to 1.02
|
0.98 µg/mL
Interval 0.78 to 1.22
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 2x:1x:2x vs. Prevnar 13®
PT6B
|
0.36 µg/mL
Interval 0.19 to 0.69
|
2.24 µg/mL
Interval 1.54 to 3.24
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 2x:1x:2x vs. Prevnar 13®
PT1
|
0.77 µg/mL
Interval 0.6 to 0.99
|
1.48 µg/mL
Interval 1.2 to 1.83
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 2x:1x:2x vs. Prevnar 13®
PT5
|
0.83 µg/mL
Interval 0.7 to 1.02
|
1.63 µg/mL
Interval 1.25 to 2.14
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 2x:1x:2x vs. Prevnar 13®
PT6A
|
0.85 µg/mL
Interval 0.49 to 1.48
|
2.75 µg/mL
Interval 2.28 to 3.31
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 2x:1x:2x vs. Prevnar 13®
PT7F
|
1.39 µg/mL
Interval 1.1 to 1.77
|
2.90 µg/mL
Interval 2.48 to 3.39
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 2x:1x:2x vs. Prevnar 13®
PT 9V
|
0.76 µg/mL
Interval 0.58 to 1.0
|
1.35 µg/mL
Interval 1.05 to 1.74
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 2x:1x:2x vs. Prevnar 13®
PT14
|
3.20 µg/mL
Interval 2.37 to 4.33
|
5.01 µg/mL
Interval 3.94 to 6.38
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 2x:1x:2x vs. Prevnar 13®
PT18C
|
1.20 µg/mL
Interval 0.92 to 1.57
|
1.41 µg/mL
Interval 1.14 to 1.74
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 2x:1x:2x vs. Prevnar 13®
PT19A
|
0.96 µg/mL
Interval 0.75 to 1.23
|
1.45 µg/mL
Interval 1.13 to 1.86
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 2x:1x:2x vs. Prevnar 13®
PT19F
|
2.10 µg/mL
Interval 1.57 to 2.81
|
1.89 µg/mL
Interval 1.56 to 2.3
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 2x:1x:2x vs. Prevnar 13®
PT23F
|
0.76 µg/mL
Interval 0.51 to 1.13
|
1.13 µg/mL
Interval 0.87 to 1.47
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 2x:1x:2x vs. Prevnar 13®
non-PT22F
|
2.71 µg/mL
Interval 1.95 to 3.78
|
0.06 µg/mL
Interval 0.05 to 0.08
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 2x:1x:2x vs. Prevnar 13®
non-PT33F
|
0.88 µg/mL
Interval 0.57 to 1.34
|
0.06 µg/mL
Interval 0.04 to 0.08
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Month 7 (1 month PD3)Population: Randomized and treated infants with results available for the outcome measure and no protocol violations are included.
The IgG antibody GMCs of each Prevnar 13®-type (PT) or non-Prevnar 13® type (non-PT) serotype at 1 month PD3 following V114 or Prevnar 13® treatment were determined with the pneumococcal electrochemiluminescence (Pn ECL) assay. Data reflect the GMC of each serotype.
Outcome measures
| Measure |
Adult V114: 1x:1x:1x
n=50 Participants
On Day 1, adults receive a single vaccination of V114 1x:1x:1x (containing 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 4.0 μg of polysaccharide serotype 6B; and 125 µg of APA).
|
Adult V114: 2x.2x.2x
n=51 Participants
On Day 1, adults receive a single vaccination of V114 2x:2x:2x (containing 4.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 8.0 μg of polysaccharide serotype 6B; and 250 µg of APA).
|
Infant V114: 2x:2x:2x
Infants receive 4 total V114: 2x:2x:2x (containing 4.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 8.0 μg of polysaccharide serotype 6B; and 250 µg of APA) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
Infant V114: 0.5x:0.5x:2x
Infants receive 4 total V114 0.5x:0.5x:2x (containing 1.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 2.0 μg of polysaccharide serotype 6B; and 250 µg of APA) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
Infant V114: 1x:1x:2x
Infants receive 4 total V114 1x:1x:2x (containing 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 4.0 μg of polysaccharide serotype 6B; and 250 µg of APA) total vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
Infant Prevnar 13®
Infants receive 4 total Prevnar 13® (containing 2.2 µg of pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, and 23F; and 4.4 µg of serotype 6B) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
|---|---|---|---|---|---|---|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 2x:2x:2x vs. Prevnar 13®
PT4
|
1.48 µg/mL
Interval 1.17 to 1.87
|
0.98 µg/mL
Interval 0.78 to 1.22
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 2x:2x:2x vs. Prevnar 13®
PT9V
|
1.18 µg/mL
Interval 0.87 to 1.61
|
1.35 µg/mL
Interval 1.05 to 1.74
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 2x:2x:2x vs. Prevnar 13®
PT1
|
1.16 µg/mL
Interval 0.94 to 1.42
|
1.48 µg/mL
Interval 1.2 to 1.83
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 2x:2x:2x vs. Prevnar 13®
PT3
|
1.15 µg/mL
Interval 0.95 to 1.41
|
0.43 µg/mL
Interval 0.35 to 0.54
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 2x:2x:2x vs. Prevnar 13®
PT5
|
1.11 µg/mL
Interval 0.82 to 1.5
|
1.63 µg/mL
Interval 1.25 to 2.14
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 2x:2x:2x vs. Prevnar 13®
PT6A
|
0.91 µg/mL
Interval 0.5 to 1.67
|
2.75 µg/mL
Interval 2.28 to 3.31
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 2x:2x:2x vs. Prevnar 13®
PT6B
|
0.24 µg/mL
Interval 0.13 to 0.44
|
2.24 µg/mL
Interval 1.54 to 3.24
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 2x:2x:2x vs. Prevnar 13®
PT7F
|
2.12 µg/mL
Interval 1.54 to 2.91
|
2.90 µg/mL
Interval 2.48 to 3.39
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 2x:2x:2x vs. Prevnar 13®
PT14
|
5.17 µg/mL
Interval 3.83 to 6.99
|
5.01 µg/mL
Interval 3.94 to 6.38
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 2x:2x:2x vs. Prevnar 13®
PT18C
|
1.35 µg/mL
Interval 0.97 to 1.88
|
1.41 µg/mL
Interval 1.14 to 1.74
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 2x:2x:2x vs. Prevnar 13®
PT19A
|
1.37 µg/mL
Interval 0.94 to 1.99
|
1.45 µg/mL
Interval 1.13 to 1.86
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 2x:2x:2x vs. Prevnar 13®
PT19F
|
2.35 µg/mL
Interval 1.59 to 3.47
|
1.89 µg/mL
Interval 1.56 to 2.3
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 2x:2x:2x vs. Prevnar 13®
PT23F
|
0.85 µg/mL
Interval 0.55 to 1.31
|
1.13 µg/mL
Interval 0.87 to 1.47
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 2x:2x:2x vs. Prevnar 13®
non-PT22F
|
4.72 µg/mL
Interval 3.46 to 6.43
|
0.06 µg/mL
Interval 0.05 to 0.08
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 2x:2x:2x vs. Prevnar 13®
non-PT33F
|
0.90 µg/mL
Interval 0.51 to 1.57
|
0.06 µg/mL
Interval 0.04 to 0.08
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Month 7 (1 month PD3)Population: Randomized and treated infants with results available for the outcome measure and no protocol violations are included.
The IgG antibody GMCs of each Prevnar 13®-type (PT) or non-Prevnar 13® type (non-PT) serotype at 1 month PD3 following V114 or Prevnar 13® treatment were determined with the pneumococcal electrochemiluminescence (Pn ECL) assay. Data reflect the GMC of each serotype.
Outcome measures
| Measure |
Adult V114: 1x:1x:1x
n=48 Participants
On Day 1, adults receive a single vaccination of V114 1x:1x:1x (containing 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 4.0 μg of polysaccharide serotype 6B; and 125 µg of APA).
|
Adult V114: 2x.2x.2x
n=51 Participants
On Day 1, adults receive a single vaccination of V114 2x:2x:2x (containing 4.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 8.0 μg of polysaccharide serotype 6B; and 250 µg of APA).
|
Infant V114: 2x:2x:2x
Infants receive 4 total V114: 2x:2x:2x (containing 4.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 8.0 μg of polysaccharide serotype 6B; and 250 µg of APA) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
Infant V114: 0.5x:0.5x:2x
Infants receive 4 total V114 0.5x:0.5x:2x (containing 1.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 2.0 μg of polysaccharide serotype 6B; and 250 µg of APA) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
Infant V114: 1x:1x:2x
Infants receive 4 total V114 1x:1x:2x (containing 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 4.0 μg of polysaccharide serotype 6B; and 250 µg of APA) total vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
Infant Prevnar 13®
Infants receive 4 total Prevnar 13® (containing 2.2 µg of pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, and 23F; and 4.4 µg of serotype 6B) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
|---|---|---|---|---|---|---|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 0.5x:0.5x:2x vs. Prevnar 13®
PT3
|
0.95 µg/mL
Interval 0.78 to 1.17
|
0.43 µg/mL
Interval 0.35 to 0.54
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 0.5x:0.5x:2x vs. Prevnar 13®
PT4
|
0.95 µg/mL
Interval 0.78 to 1.19
|
0.98 µg/mL
Interval 0.78 to 1.22
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 0.5x:0.5x:2x vs. Prevnar 13®
PT5
|
0.87 µg/mL
Interval 0.65 to 1.15
|
1.63 µg/mL
Interval 1.25 to 2.14
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 0.5x:0.5x:2x vs. Prevnar 13®
PT6B
|
0.80 µg/mL
Interval 0.46 to 1.37
|
2.24 µg/mL
Interval 1.54 to 3.24
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 0.5x:0.5x:2x vs. Prevnar 13®
PT7F
|
1.73 µg/mL
Interval 1.29 to 2.32
|
2.90 µg/mL
Interval 2.48 to 3.39
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 0.5x:0.5x:2x vs. Prevnar 13®
PT19F
|
1.67 µg/mL
Interval 1.35 to 2.07
|
1.89 µg/mL
Interval 1.56 to 2.3
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 0.5x:0.5x:2x vs. Prevnar 13®
PT23F
|
0.78 µg/mL
Interval 0.61 to 1.0
|
1.13 µg/mL
Interval 0.87 to 1.47
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 0.5x:0.5x:2x vs. Prevnar 13®
non-PT22F
|
3.41 µg/mL
Interval 2.74 to 4.25
|
0.06 µg/mL
Interval 0.05 to 0.08
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 0.5x:0.5x:2x vs. Prevnar 13®
non-PT33F
|
1.47 µg/mL
Interval 0.97 to 2.23
|
0.06 µg/mL
Interval 0.04 to 0.08
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 0.5x:0.5x:2x vs. Prevnar 13®
PT1
|
1.01 µg/mL
Interval 0.79 to 1.29
|
1.48 µg/mL
Interval 1.2 to 1.83
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 0.5x:0.5x:2x vs. Prevnar 13®
PT6A
|
1.35 µg/mL
Interval 0.9 to 2.01
|
2.75 µg/mL
Interval 2.28 to 3.31
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 0.5x:0.5x:2x vs. Prevnar 13®
PT9V
|
1.07 µg/mL
Interval 0.84 to 1.35
|
1.35 µg/mL
Interval 1.05 to 1.74
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 0.5x:0.5x:2x vs. Prevnar 13®
PT14
|
3.71 µg/mL
Interval 2.67 to 5.17
|
5.01 µg/mL
Interval 3.94 to 6.38
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 0.5x:0.5x:2x vs. Prevnar 13®
PT18C
|
0.94 µg/mL
Interval 0.69 to 1.27
|
1.41 µg/mL
Interval 1.14 to 1.74
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 0.5x:0.5x:2x vs. Prevnar 13®
PT19A
|
1.01 µg/mL
Interval 0.8 to 1.28
|
1.45 µg/mL
Interval 1.13 to 1.86
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Month 7 (1 month PD3)Population: Randomized and treated infants with results available for the outcome measure and no protocol violations are included.
The IgG antibody GMCs of each Prevnar 13®-type (PT) or non-Prevnar 13® type (non-PT) serotype at 1 month PD3 following V114 or Prevnar 13® treatment were determined with the pneumococcal electrochemiluminescence (Pn ECL) assay. Data reflect the GMC of each serotype.
Outcome measures
| Measure |
Adult V114: 1x:1x:1x
n=50 Participants
On Day 1, adults receive a single vaccination of V114 1x:1x:1x (containing 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 4.0 μg of polysaccharide serotype 6B; and 125 µg of APA).
|
Adult V114: 2x.2x.2x
n=51 Participants
On Day 1, adults receive a single vaccination of V114 2x:2x:2x (containing 4.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 8.0 μg of polysaccharide serotype 6B; and 250 µg of APA).
|
Infant V114: 2x:2x:2x
Infants receive 4 total V114: 2x:2x:2x (containing 4.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 8.0 μg of polysaccharide serotype 6B; and 250 µg of APA) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
Infant V114: 0.5x:0.5x:2x
Infants receive 4 total V114 0.5x:0.5x:2x (containing 1.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 2.0 μg of polysaccharide serotype 6B; and 250 µg of APA) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
Infant V114: 1x:1x:2x
Infants receive 4 total V114 1x:1x:2x (containing 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 4.0 μg of polysaccharide serotype 6B; and 250 µg of APA) total vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
Infant Prevnar 13®
Infants receive 4 total Prevnar 13® (containing 2.2 µg of pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, and 23F; and 4.4 µg of serotype 6B) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
|---|---|---|---|---|---|---|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 1x:1x:2x vs. Prevnar 13®
PT5
|
0.83 µg/mL
Interval 0.59 to 1.18
|
1.63 µg/mL
Interval 1.25 to 2.14
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 1x:1x:2x vs. Prevnar 13®
PT23F
|
0.89 µg/mL
Interval 0.58 to 1.38
|
1.13 µg/mL
Interval 0.87 to 1.47
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 1x:1x:2x vs. Prevnar 13®
non-PT33F
|
1.15 µg/mL
Interval 0.71 to 1.86
|
0.06 µg/mL
Interval 0.04 to 0.08
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 1x:1x:2x vs. Prevnar 13®
PT1
|
1.18 µg/mL
Interval 0.94 to 1.49
|
1.48 µg/mL
Interval 1.2 to 1.83
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 1x:1x:2x vs. Prevnar 13®
PT3
|
1.10 µg/mL
Interval 0.88 to 1.37
|
0.43 µg/mL
Interval 0.35 to 0.54
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 1x:1x:2x vs. Prevnar 13®
PT4
|
1.05 µg/mL
Interval 0.81 to 1.35
|
0.98 µg/mL
Interval 0.78 to 1.22
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 1x:1x:2x vs. Prevnar 13®
PT6A
|
0.92 µg/mL
Interval 0.54 to 1.58
|
2.75 µg/mL
Interval 2.28 to 3.31
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 1x:1x:2x vs. Prevnar 13®
PT6B
|
0.39 µg/mL
Interval 0.21 to 0.74
|
2.24 µg/mL
Interval 1.54 to 3.24
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 1x:1x:2x vs. Prevnar 13®
PT7F
|
1.71 µg/mL
Interval 1.27 to 2.31
|
2.90 µg/mL
Interval 2.48 to 3.39
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 1x:1x:2x vs. Prevnar 13®
PT9V
|
0.92 µg/mL
Interval 0.66 to 1.3
|
1.35 µg/mL
Interval 1.05 to 1.74
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 1x:1x:2x vs. Prevnar 13®
PT14
|
3.94 µg/mL
Interval 3.02 to 5.14
|
5.01 µg/mL
Interval 3.94 to 6.38
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 1x:1x:2x vs. Prevnar 13®
PT18C
|
1.02 µg/mL
Interval 0.77 to 1.35
|
1.41 µg/mL
Interval 1.14 to 1.74
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 1x:1x:2x vs. Prevnar 13®
PT19A
|
0.79 µg/mL
Interval 0.58 to 1.08
|
1.45 µg/mL
Interval 1.13 to 1.86
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 1x:1x:2x vs. Prevnar 13®
PT19F
|
1.84 µg/mL
Interval 1.35 to 2.52
|
1.89 µg/mL
Interval 1.56 to 2.3
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 1x:1x:2x vs. Prevnar 13®
non-PT22F
|
4.17 µg/mL
Interval 3.1 to 5.62
|
0.06 µg/mL
Interval 0.05 to 0.08
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Month 7 (1 month PD3)Population: All randomized and treated infants with results available for the outcome measure and no protocol violations in the V114 arms are included. Results are pooled across arms to determine the impact of increased polysaccharide concentration on antibody concentrations across V114 formulations.
A mulitvariate regression model was used to evaluate the impact of increasing polysaccharide concentration from 1x to 2x on the natural logarithm of serotype-specific antibody concentrations 1 month PD3. Data points show the mean estimated fold-rise-per-unit change in antibody concentration following an increase from 1x to 2x in polysaccharide concentration. For each Prevnar 13®-type (PT) or non-Prevnar 13®-type (non-PT) serotypes, values \>1.0 show an increase in antibody concentration whereas values \<1.0 show a decrease in antibody concentration.
Outcome measures
| Measure |
Adult V114: 1x:1x:1x
n=249 Participants
On Day 1, adults receive a single vaccination of V114 1x:1x:1x (containing 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 4.0 μg of polysaccharide serotype 6B; and 125 µg of APA).
|
Adult V114: 2x.2x.2x
On Day 1, adults receive a single vaccination of V114 2x:2x:2x (containing 4.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 8.0 μg of polysaccharide serotype 6B; and 250 µg of APA).
|
Infant V114: 2x:2x:2x
Infants receive 4 total V114: 2x:2x:2x (containing 4.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 8.0 μg of polysaccharide serotype 6B; and 250 µg of APA) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
Infant V114: 0.5x:0.5x:2x
Infants receive 4 total V114 0.5x:0.5x:2x (containing 1.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 2.0 μg of polysaccharide serotype 6B; and 250 µg of APA) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
Infant V114: 1x:1x:2x
Infants receive 4 total V114 1x:1x:2x (containing 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 4.0 μg of polysaccharide serotype 6B; and 250 µg of APA) total vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
Infant Prevnar 13®
Infants receive 4 total Prevnar 13® (containing 2.2 µg of pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, and 23F; and 4.4 µg of serotype 6B) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
|---|---|---|---|---|---|---|
|
Estimated Fold-Rise Per-Unit Change in Serotype-specific Antibody Concentrations Following an Increase in Polysaccharide Concentrations in Infants at 1 Month Postdose 3 (PD3)
PT6A
|
1.09 Estimated Fold-rise per-unit Change
Interval 0.83 to 1.43
|
—
|
—
|
—
|
—
|
—
|
|
Estimated Fold-Rise Per-Unit Change in Serotype-specific Antibody Concentrations Following an Increase in Polysaccharide Concentrations in Infants at 1 Month Postdose 3 (PD3)
PT6B
|
0.73 Estimated Fold-rise per-unit Change
Interval 0.51 to 1.05
|
—
|
—
|
—
|
—
|
—
|
|
Estimated Fold-Rise Per-Unit Change in Serotype-specific Antibody Concentrations Following an Increase in Polysaccharide Concentrations in Infants at 1 Month Postdose 3 (PD3)
PT18C
|
1.45 Estimated Fold-rise per-unit Change
Interval 1.23 to 1.7
|
—
|
—
|
—
|
—
|
—
|
|
Estimated Fold-Rise Per-Unit Change in Serotype-specific Antibody Concentrations Following an Increase in Polysaccharide Concentrations in Infants at 1 Month Postdose 3 (PD3)
non-PT33F
|
0.94 Estimated Fold-rise per-unit Change
Interval 0.69 to 1.27
|
—
|
—
|
—
|
—
|
—
|
|
Estimated Fold-Rise Per-Unit Change in Serotype-specific Antibody Concentrations Following an Increase in Polysaccharide Concentrations in Infants at 1 Month Postdose 3 (PD3)
PT1
|
1.19 Estimated Fold-rise per-unit Change
Interval 1.0 to 1.42
|
—
|
—
|
—
|
—
|
—
|
|
Estimated Fold-Rise Per-Unit Change in Serotype-specific Antibody Concentrations Following an Increase in Polysaccharide Concentrations in Infants at 1 Month Postdose 3 (PD3)
PT3
|
1.13 Estimated Fold-rise per-unit Change
Interval 0.94 to 1.35
|
—
|
—
|
—
|
—
|
—
|
|
Estimated Fold-Rise Per-Unit Change in Serotype-specific Antibody Concentrations Following an Increase in Polysaccharide Concentrations in Infants at 1 Month Postdose 3 (PD3)
PT4
|
1.44 Estimated Fold-rise per-unit Change
Interval 1.22 to 1.69
|
—
|
—
|
—
|
—
|
—
|
|
Estimated Fold-Rise Per-Unit Change in Serotype-specific Antibody Concentrations Following an Increase in Polysaccharide Concentrations in Infants at 1 Month Postdose 3 (PD3)
PT5
|
1.29 Estimated Fold-rise per-unit Change
Interval 1.07 to 1.55
|
—
|
—
|
—
|
—
|
—
|
|
Estimated Fold-Rise Per-Unit Change in Serotype-specific Antibody Concentrations Following an Increase in Polysaccharide Concentrations in Infants at 1 Month Postdose 3 (PD3)
PT7F
|
1.40 Estimated Fold-rise per-unit Change
Interval 1.16 to 1.68
|
—
|
—
|
—
|
—
|
—
|
|
Estimated Fold-Rise Per-Unit Change in Serotype-specific Antibody Concentrations Following an Increase in Polysaccharide Concentrations in Infants at 1 Month Postdose 3 (PD3)
PT9V
|
1.15 Estimated Fold-rise per-unit Change
Interval 0.95 to 1.38
|
—
|
—
|
—
|
—
|
—
|
|
Estimated Fold-Rise Per-Unit Change in Serotype-specific Antibody Concentrations Following an Increase in Polysaccharide Concentrations in Infants at 1 Month Postdose 3 (PD3)
PT14
|
1.47 Estimated Fold-rise per-unit Change
Interval 1.13 to 1.91
|
—
|
—
|
—
|
—
|
—
|
|
Estimated Fold-Rise Per-Unit Change in Serotype-specific Antibody Concentrations Following an Increase in Polysaccharide Concentrations in Infants at 1 Month Postdose 3 (PD3)
PT19A
|
1.30 Estimated Fold-rise per-unit Change
Interval 1.09 to 1.54
|
—
|
—
|
—
|
—
|
—
|
|
Estimated Fold-Rise Per-Unit Change in Serotype-specific Antibody Concentrations Following an Increase in Polysaccharide Concentrations in Infants at 1 Month Postdose 3 (PD3)
PT19F
|
1.47 Estimated Fold-rise per-unit Change
Interval 1.23 to 1.76
|
—
|
—
|
—
|
—
|
—
|
|
Estimated Fold-Rise Per-Unit Change in Serotype-specific Antibody Concentrations Following an Increase in Polysaccharide Concentrations in Infants at 1 Month Postdose 3 (PD3)
PT22F
|
1.64 Estimated Fold-rise per-unit Change
Interval 1.32 to 2.04
|
—
|
—
|
—
|
—
|
—
|
|
Estimated Fold-Rise Per-Unit Change in Serotype-specific Antibody Concentrations Following an Increase in Polysaccharide Concentrations in Infants at 1 Month Postdose 3 (PD3)
non-PT23F
|
1.20 Estimated Fold-rise per-unit Change
Interval 0.97 to 1.48
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Month 7 (1 month PD3)Population: All randomized and treated infants with results available for the outcome measure and no protocol violations in the V114 arms are included.
A mulitvariate regression model was used to evaluate the impact of increasing APA concentration on the natural logarithm of serotype-specific antibody concentrations 1 month PD3. Data points show the mean estimated fold-rise-per-unit change in antibody concentration following an increase in APA. For each Prevnar 13®-type (PT) or non-Prevnar 13®-type (non-PT) serotypes, values \>1.0 show an increase in antibody concentration whereas values \<1.0 show a decrease in antibody concentration.
Outcome measures
| Measure |
Adult V114: 1x:1x:1x
n=249 Participants
On Day 1, adults receive a single vaccination of V114 1x:1x:1x (containing 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 4.0 μg of polysaccharide serotype 6B; and 125 µg of APA).
|
Adult V114: 2x.2x.2x
On Day 1, adults receive a single vaccination of V114 2x:2x:2x (containing 4.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 8.0 μg of polysaccharide serotype 6B; and 250 µg of APA).
|
Infant V114: 2x:2x:2x
Infants receive 4 total V114: 2x:2x:2x (containing 4.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 8.0 μg of polysaccharide serotype 6B; and 250 µg of APA) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
Infant V114: 0.5x:0.5x:2x
Infants receive 4 total V114 0.5x:0.5x:2x (containing 1.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 2.0 μg of polysaccharide serotype 6B; and 250 µg of APA) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
Infant V114: 1x:1x:2x
Infants receive 4 total V114 1x:1x:2x (containing 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 4.0 μg of polysaccharide serotype 6B; and 250 µg of APA) total vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
Infant Prevnar 13®
Infants receive 4 total Prevnar 13® (containing 2.2 µg of pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, and 23F; and 4.4 µg of serotype 6B) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
|---|---|---|---|---|---|---|
|
Estimated Fold-Rise Per-Unit Change on Serotype-specific Antibody Concentrations Following an Increase in Aluminum Phosphate Adjuvant (APA) Concentration 1 Month Postdose 3 (PD3) in Infants
PT1
|
0.84 Estimated Fold-rise per-unit Change
Interval 0.68 to 1.03
|
—
|
—
|
—
|
—
|
—
|
|
Estimated Fold-Rise Per-Unit Change on Serotype-specific Antibody Concentrations Following an Increase in Aluminum Phosphate Adjuvant (APA) Concentration 1 Month Postdose 3 (PD3) in Infants
PT3
|
0.84 Estimated Fold-rise per-unit Change
Interval 0.68 to 1.04
|
—
|
—
|
—
|
—
|
—
|
|
Estimated Fold-Rise Per-Unit Change on Serotype-specific Antibody Concentrations Following an Increase in Aluminum Phosphate Adjuvant (APA) Concentration 1 Month Postdose 3 (PD3) in Infants
PT4
|
0.77 Estimated Fold-rise per-unit Change
Interval 0.63 to 0.95
|
—
|
—
|
—
|
—
|
—
|
|
Estimated Fold-Rise Per-Unit Change on Serotype-specific Antibody Concentrations Following an Increase in Aluminum Phosphate Adjuvant (APA) Concentration 1 Month Postdose 3 (PD3) in Infants
PT5
|
0.76 Estimated Fold-rise per-unit Change
Interval 0.61 to 0.95
|
—
|
—
|
—
|
—
|
—
|
|
Estimated Fold-Rise Per-Unit Change on Serotype-specific Antibody Concentrations Following an Increase in Aluminum Phosphate Adjuvant (APA) Concentration 1 Month Postdose 3 (PD3) in Infants
PT6A
|
0.89 Estimated Fold-rise per-unit Change
Interval 0.66 to 1.2
|
—
|
—
|
—
|
—
|
—
|
|
Estimated Fold-Rise Per-Unit Change on Serotype-specific Antibody Concentrations Following an Increase in Aluminum Phosphate Adjuvant (APA) Concentration 1 Month Postdose 3 (PD3) in Infants
PT6B
|
0.74 Estimated Fold-rise per-unit Change
Interval 0.52 to 1.05
|
—
|
—
|
—
|
—
|
—
|
|
Estimated Fold-Rise Per-Unit Change on Serotype-specific Antibody Concentrations Following an Increase in Aluminum Phosphate Adjuvant (APA) Concentration 1 Month Postdose 3 (PD3) in Infants
PT22F
|
1.37 Estimated Fold-rise per-unit Change
Interval 1.09 to 1.73
|
—
|
—
|
—
|
—
|
—
|
|
Estimated Fold-Rise Per-Unit Change on Serotype-specific Antibody Concentrations Following an Increase in Aluminum Phosphate Adjuvant (APA) Concentration 1 Month Postdose 3 (PD3) in Infants
non-PT23F
|
0.73 Estimated Fold-rise per-unit Change
Interval 0.57 to 0.95
|
—
|
—
|
—
|
—
|
—
|
|
Estimated Fold-Rise Per-Unit Change on Serotype-specific Antibody Concentrations Following an Increase in Aluminum Phosphate Adjuvant (APA) Concentration 1 Month Postdose 3 (PD3) in Infants
non-PT33F
|
1.00 Estimated Fold-rise per-unit Change
Interval 0.75 to 1.33
|
—
|
—
|
—
|
—
|
—
|
|
Estimated Fold-Rise Per-Unit Change on Serotype-specific Antibody Concentrations Following an Increase in Aluminum Phosphate Adjuvant (APA) Concentration 1 Month Postdose 3 (PD3) in Infants
PT7F
|
1.01 Estimated Fold-rise per-unit Change
Interval 0.81 to 1.26
|
—
|
—
|
—
|
—
|
—
|
|
Estimated Fold-Rise Per-Unit Change on Serotype-specific Antibody Concentrations Following an Increase in Aluminum Phosphate Adjuvant (APA) Concentration 1 Month Postdose 3 (PD3) in Infants
PT9V
|
0.83 Estimated Fold-rise per-unit Change
Interval 0.66 to 1.04
|
—
|
—
|
—
|
—
|
—
|
|
Estimated Fold-Rise Per-Unit Change on Serotype-specific Antibody Concentrations Following an Increase in Aluminum Phosphate Adjuvant (APA) Concentration 1 Month Postdose 3 (PD3) in Infants
PT14
|
1.48 Estimated Fold-rise per-unit Change
Interval 1.16 to 1.89
|
—
|
—
|
—
|
—
|
—
|
|
Estimated Fold-Rise Per-Unit Change on Serotype-specific Antibody Concentrations Following an Increase in Aluminum Phosphate Adjuvant (APA) Concentration 1 Month Postdose 3 (PD3) in Infants
PT18C
|
0.75 Estimated Fold-rise per-unit Change
Interval 0.6 to 0.94
|
—
|
—
|
—
|
—
|
—
|
|
Estimated Fold-Rise Per-Unit Change on Serotype-specific Antibody Concentrations Following an Increase in Aluminum Phosphate Adjuvant (APA) Concentration 1 Month Postdose 3 (PD3) in Infants
PT19A
|
0.77 Estimated Fold-rise per-unit Change
Interval 0.61 to 0.97
|
—
|
—
|
—
|
—
|
—
|
|
Estimated Fold-Rise Per-Unit Change on Serotype-specific Antibody Concentrations Following an Increase in Aluminum Phosphate Adjuvant (APA) Concentration 1 Month Postdose 3 (PD3) in Infants
PT19F
|
1.01 Estimated Fold-rise per-unit Change
Interval 0.79 to 1.27
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Month 7 (1 month PD3)Population: Randomized and treated infants with results available for the outcome measure and no protocol violations are included.
The percentage of infant participants with antibody responses meeting the World Health Organization (WHO)-accepted threshold value of ≥0.35 μg/mL was determined for each Prevnar 13®-type (PT) or non-Prevnar 13®-type (non-PT) pneumococcal serotype. Antibody levels were determined with the pneumococcal electrochemiluminescence (Pn ECL) assay for each V114 formulation with 2x APA and varying pneumococcal polysaccharide.
Outcome measures
| Measure |
Adult V114: 1x:1x:1x
n=48 Participants
On Day 1, adults receive a single vaccination of V114 1x:1x:1x (containing 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 4.0 μg of polysaccharide serotype 6B; and 125 µg of APA).
|
Adult V114: 2x.2x.2x
n=51 Participants
On Day 1, adults receive a single vaccination of V114 2x:2x:2x (containing 4.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 8.0 μg of polysaccharide serotype 6B; and 250 µg of APA).
|
Infant V114: 2x:2x:2x
n=50 Participants
Infants receive 4 total V114: 2x:2x:2x (containing 4.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 8.0 μg of polysaccharide serotype 6B; and 250 µg of APA) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
Infant V114: 0.5x:0.5x:2x
n=50 Participants
Infants receive 4 total V114 0.5x:0.5x:2x (containing 1.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 2.0 μg of polysaccharide serotype 6B; and 250 µg of APA) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
Infant V114: 1x:1x:2x
Infants receive 4 total V114 1x:1x:2x (containing 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 4.0 μg of polysaccharide serotype 6B; and 250 µg of APA) total vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
Infant Prevnar 13®
Infants receive 4 total Prevnar 13® (containing 2.2 µg of pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, and 23F; and 4.4 µg of serotype 6B) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
|---|---|---|---|---|---|---|
|
Percentage of Infant Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 3 (PD3): V114 Formulations With 2x Aluminum Phosphate Adjuvant (APA)
PT1
|
94.6 Percentage of Participants
Interval 81.81 to 99.34
|
85.7 Percentage of Participants
Interval 71.46 to 94.57
|
97.0 Percentage of Participants
Interval 84.24 to 99.92
|
97.1 Percentage of Participants
Interval 84.67 to 99.93
|
—
|
—
|
|
Percentage of Infant Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 3 (PD3): V114 Formulations With 2x Aluminum Phosphate Adjuvant (APA)
PT3
|
91.7 Percentage of Participants
Interval 77.53 to 98.25
|
85.7 Percentage of Participants
Interval 71.46 to 94.57
|
100.0 Percentage of Participants
Interval 89.42 to 100.0
|
88.2 Percentage of Participants
Interval 72.55 to 96.7
|
—
|
—
|
|
Percentage of Infant Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 3 (PD3): V114 Formulations With 2x Aluminum Phosphate Adjuvant (APA)
PT6A
|
91.7 Percentage of Participants
Interval 77.53 to 98.25
|
66.7 Percentage of Participants
Interval 50.45 to 80.43
|
72.7 Percentage of Participants
Interval 54.48 to 86.7
|
76.5 Percentage of Participants
Interval 58.83 to 89.25
|
—
|
—
|
|
Percentage of Infant Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 3 (PD3): V114 Formulations With 2x Aluminum Phosphate Adjuvant (APA)
PT14
|
94.6 Percentage of Participants
Interval 81.81 to 99.34
|
97.6 Percentage of Participants
Interval 87.43 to 99.94
|
100.00 Percentage of Participants
Interval 89.42 to 100.0
|
100.0 Percentage of Participants
Interval 89.72 to 100.0
|
—
|
—
|
|
Percentage of Infant Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 3 (PD3): V114 Formulations With 2x Aluminum Phosphate Adjuvant (APA)
PT19A
|
91.9 Percentage of Participants
Interval 78.09 to 98.3
|
88.1 Percentage of Participants
Interval 74.37 to 96.02
|
93.9 Percentage of Participants
Interval 79.77 to 99.26
|
88.2 Percentage of Participants
Interval 72.55 to 96.7
|
—
|
—
|
|
Percentage of Infant Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 3 (PD3): V114 Formulations With 2x Aluminum Phosphate Adjuvant (APA)
PT19F
|
97.3 Percentage of Participants
Interval 85.84 to 99.93
|
95.2 Percentage of Participants
Interval 83.84 to 99.42
|
97.0 Percentage of Participants
Interval 84.24 to 99.92
|
94.1 Percentage of Participants
Interval 80.32 to 99.28
|
—
|
—
|
|
Percentage of Infant Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 3 (PD3): V114 Formulations With 2x Aluminum Phosphate Adjuvant (APA)
PT23F
|
83.3 Percentage of Participants
Interval 67.19 to 93.63
|
78.6 Percentage of Participants
Interval 63.19 to 89.7
|
84.8 Percentage of Participants
Interval 68.1 to 94.89
|
85.3 Percentage of Participants
Interval 68.94 to 95.05
|
—
|
—
|
|
Percentage of Infant Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 3 (PD3): V114 Formulations With 2x Aluminum Phosphate Adjuvant (APA)
non-PT33F
|
91.9 Percentage of Participants
Interval 78.09 to 98.3
|
76.2 Percentage of Participants
Interval 60.55 to 87.95
|
72.7 Percentage of Participants
Interval 54.48 to 86.7
|
82.4 Percentage of Participants
Interval 65.47 to 93.24
|
—
|
—
|
|
Percentage of Infant Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 3 (PD3): V114 Formulations With 2x Aluminum Phosphate Adjuvant (APA)
PT4
|
91.7 Percentage of Participants
Interval 77.53 to 98.25
|
95.2 Percentage of Participants
Interval 83.84 to 99.42
|
97.0 Percentage of Participants
Interval 84.24 to 99.92
|
88.2 Percentage of Participants
Interval 72.55 to 96.7
|
—
|
—
|
|
Percentage of Infant Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 3 (PD3): V114 Formulations With 2x Aluminum Phosphate Adjuvant (APA)
PT5
|
88.9 Percentage of Participants
Interval 73.94 to 96.89
|
78.6 Percentage of Participants
Interval 63.19 to 89.7
|
93.9 Percentage of Participants
Interval 79.77 to 99.26
|
88.2 Percentage of Participants
Interval 72.55 to 96.7
|
—
|
—
|
|
Percentage of Infant Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 3 (PD3): V114 Formulations With 2x Aluminum Phosphate Adjuvant (APA)
PT6B
|
69.4 Percentage of Participants
Interval 51.89 to 83.65
|
47.6 Percentage of Participants
Interval 32.0 to 63.58
|
33.3 Percentage of Participants
Interval 17.96 to 51.83
|
52.9 Percentage of Participants
Interval 35.13 to 70.22
|
—
|
—
|
|
Percentage of Infant Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 3 (PD3): V114 Formulations With 2x Aluminum Phosphate Adjuvant (APA)
PT7F
|
97.2 Percentage of Participants
Interval 85.47 to 99.93
|
100.00 Percentage of Participants
Interval 91.59 to 100.0
|
93.9 Percentage of Participants
Interval 79.77 to 99.26
|
97.1 Percentage of Participants
Interval 84.67 to 99.93
|
—
|
—
|
|
Percentage of Infant Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 3 (PD3): V114 Formulations With 2x Aluminum Phosphate Adjuvant (APA)
PT9V
|
94.4 Percentage of Participants
Interval 81.34 to 99.32
|
78.6 Percentage of Participants
Interval 63.19 to 89.7
|
87.9 Percentage of Participants
Interval 71.8 to 96.6
|
85.3 Percentage of Participants
Interval 68.94 to 95.05
|
—
|
—
|
|
Percentage of Infant Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 3 (PD3): V114 Formulations With 2x Aluminum Phosphate Adjuvant (APA)
PT18C
|
91.9 Percentage of Participants
Interval 78.09 to 98.3
|
90.5 Percentage of Participants
Interval 77.38 to 97.34
|
93.9 Percentage of Participants
Interval 79.77 to 99.26
|
94.1 Percentage of Participants
Interval 80.32 to 99.28
|
—
|
—
|
|
Percentage of Infant Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 3 (PD3): V114 Formulations With 2x Aluminum Phosphate Adjuvant (APA)
non-PT22F
|
100.00 Percentage of Participants
Interval 90.26 to 100.0
|
97.6 Percentage of Participants
Interval 87.43 to 99.94
|
97.0 Percentage of Participants
Interval 84.24 to 99.92
|
100.0 Percentage of Participants
Interval 89.72 to 100.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Month 7 (1 month PD3)Population: Randomized and treated infants with results available for the outcome measure and no protocol violations are included.
The percentage of infant participants with antibody responses meeting the World Health Organization (WHO)-accepted threshold value of ≥0.35 μg/mL was determined for each Prevnar 13®-type (PT) or non-Prevnar 13®-type (non-PT) pneumococcal serotype. Antibody levels were determined with the pneumococcal electrochemiluminescence (Pn ECL) assay for each V114 formulation with 1x APA and varying pneumococcal polysaccharide.
Outcome measures
| Measure |
Adult V114: 1x:1x:1x
n=50 Participants
On Day 1, adults receive a single vaccination of V114 1x:1x:1x (containing 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 4.0 μg of polysaccharide serotype 6B; and 125 µg of APA).
|
Adult V114: 2x.2x.2x
On Day 1, adults receive a single vaccination of V114 2x:2x:2x (containing 4.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 8.0 μg of polysaccharide serotype 6B; and 250 µg of APA).
|
Infant V114: 2x:2x:2x
Infants receive 4 total V114: 2x:2x:2x (containing 4.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 8.0 μg of polysaccharide serotype 6B; and 250 µg of APA) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
Infant V114: 0.5x:0.5x:2x
Infants receive 4 total V114 0.5x:0.5x:2x (containing 1.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 2.0 μg of polysaccharide serotype 6B; and 250 µg of APA) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
Infant V114: 1x:1x:2x
Infants receive 4 total V114 1x:1x:2x (containing 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 4.0 μg of polysaccharide serotype 6B; and 250 µg of APA) total vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
Infant Prevnar 13®
Infants receive 4 total Prevnar 13® (containing 2.2 µg of pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, and 23F; and 4.4 µg of serotype 6B) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
|---|---|---|---|---|---|---|
|
Percentage of Infant Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 3 (PD3): V114 Formulations With 1x Aluminum Phosphate Adjuvant (APA)
PT7F
|
100.0 Percentage of Participants
Interval 90.75 to 100.0
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Infant Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 3 (PD3): V114 Formulations With 1x Aluminum Phosphate Adjuvant (APA)
PT14
|
92.1 Percentage of Participants
Interval 78.62 to 98.34
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Infant Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 3 (PD3): V114 Formulations With 1x Aluminum Phosphate Adjuvant (APA)
non-PT33F
|
86.8 Percentage of Participants
Interval 71.91 to 95.59
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Infant Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 3 (PD3): V114 Formulations With 1x Aluminum Phosphate Adjuvant (APA)
PT1
|
97.4 Percentage of Participants
Interval 86.19 to 99.93
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Infant Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 3 (PD3): V114 Formulations With 1x Aluminum Phosphate Adjuvant (APA)
PT3
|
89.5 Percentage of Participants
Interval 75.2 to 97.06
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Infant Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 3 (PD3): V114 Formulations With 1x Aluminum Phosphate Adjuvant (APA)
PT4
|
97.4 Percentage of Participants
Interval 86.19 to 99.93
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Infant Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 3 (PD3): V114 Formulations With 1x Aluminum Phosphate Adjuvant (APA)
PT5
|
94.7 Percentage of Participants
Interval 82.25 to 99.36
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Infant Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 3 (PD3): V114 Formulations With 1x Aluminum Phosphate Adjuvant (APA)
PT6A
|
86.8 Percentage of Participants
Interval 71.91 to 95.59
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Infant Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 3 (PD3): V114 Formulations With 1x Aluminum Phosphate Adjuvant (APA)
PT6B
|
65.8 Percentage of Participants
Interval 48.65 to 80.37
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Infant Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 3 (PD3): V114 Formulations With 1x Aluminum Phosphate Adjuvant (APA)
PT9V
|
86.8 Percentage of Participants
Interval 71.91 to 95.59
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Infant Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 3 (PD3): V114 Formulations With 1x Aluminum Phosphate Adjuvant (APA)
PT18C
|
97.4 Percentage of Participants
Interval 86.19 to 99.93
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Infant Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 3 (PD3): V114 Formulations With 1x Aluminum Phosphate Adjuvant (APA)
PT19A
|
97.4 Percentage of Participants
Interval 86.19 to 99.93
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Infant Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 3 (PD3): V114 Formulations With 1x Aluminum Phosphate Adjuvant (APA)
PT19F
|
100.0 Percentage of Participants
Interval 90.75 to 100.0
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Infant Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 3 (PD3): V114 Formulations With 1x Aluminum Phosphate Adjuvant (APA)
PT23F
|
89.5 Percentage of Participants
Interval 75.2 to 97.06
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Infant Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 3 (PD3): V114 Formulations With 1x Aluminum Phosphate Adjuvant (APA)
non-PT22F
|
94.7 Percentage of Participants
Interval 82.25 to 99.36
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: One month following the 4th vaccination (approximately 13 to 16 months of age).Population: Randomized and treated infants with results available for the outcome measure and no protocol violations are included.
The percentage of infant participants with antibody responses meeting the World Health Organization (WHO)-accepted threshold value of ≥0.35 μg/mL was determined for each Prevnar 13®-type (PT) or non-Prevnar 13®-type (non-PT) pneumococcal serotype. Antibody levels were determined with the pneumococcal electrochemiluminescence (Pn ECL) assay for each V114 formulation.
Outcome measures
| Measure |
Adult V114: 1x:1x:1x
n=50 Participants
On Day 1, adults receive a single vaccination of V114 1x:1x:1x (containing 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 4.0 μg of polysaccharide serotype 6B; and 125 µg of APA).
|
Adult V114: 2x.2x.2x
n=51 Participants
On Day 1, adults receive a single vaccination of V114 2x:2x:2x (containing 4.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 8.0 μg of polysaccharide serotype 6B; and 250 µg of APA).
|
Infant V114: 2x:2x:2x
Infants receive 4 total V114: 2x:2x:2x (containing 4.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 8.0 μg of polysaccharide serotype 6B; and 250 µg of APA) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
Infant V114: 0.5x:0.5x:2x
Infants receive 4 total V114 0.5x:0.5x:2x (containing 1.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 2.0 μg of polysaccharide serotype 6B; and 250 µg of APA) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
Infant V114: 1x:1x:2x
Infants receive 4 total V114 1x:1x:2x (containing 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 4.0 μg of polysaccharide serotype 6B; and 250 µg of APA) total vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
Infant Prevnar 13®
Infants receive 4 total Prevnar 13® (containing 2.2 µg of pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, and 23F; and 4.4 µg of serotype 6B) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
|---|---|---|---|---|---|---|
|
Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 1x:1x:1x vs Prenar 13®
PT7F
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
|
Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 1x:1x:1x vs Prenar 13®
PT14
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
|
Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 1x:1x:1x vs Prenar 13®
PT19F
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
|
Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 1x:1x:1x vs Prenar 13®
PT1
|
96.8 Percentage of Participants
|
100.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
|
Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 1x:1x:1x vs Prenar 13®
PT3
|
90.3 Percentage of Participants
|
75.7 Percentage of Participants
|
—
|
—
|
—
|
—
|
|
Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 1x:1x:1x vs Prenar 13®
PT4
|
90.3 Percentage of Participants
|
97.3 Percentage of Participants
|
—
|
—
|
—
|
—
|
|
Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 1x:1x:1x vs Prenar 13®
PT5
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
|
Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 1x:1x:1x vs Prenar 13®
PT6A
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
|
Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 1x:1x:1x vs Prenar 13®
PT6B
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
|
Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 1x:1x:1x vs Prenar 13®
PT9V
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
|
Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 1x:1x:1x vs Prenar 13®
PT18C
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
|
Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 1x:1x:1x vs Prenar 13®
PT19A
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
|
Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 1x:1x:1x vs Prenar 13®
PT23F
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
|
Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 1x:1x:1x vs Prenar 13®
non-PT22F
|
100.0 Percentage of Participants
|
10.8 Percentage of Participants
|
—
|
—
|
—
|
—
|
|
Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 1x:1x:1x vs Prenar 13®
non-PT33F
|
100.0 Percentage of Participants
|
2.7 Percentage of Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: One month following the 4th vaccination (approximately 13 to 16 months of age).Population: Randomized and treated infants with results available for the outcome measure and no protocol violations are included.
The percentage of infant participants with antibody responses meeting the World Health Organization (WHO)-accepted threshold value of ≥0.35 μg/mL was determined for each Prevnar 13®-type (PT) or non-Prevnar 13®-type (non-PT) pneumococcal serotype. Antibody levels were determined with the pneumococcal electrochemiluminescence (Pn ECL) assay for each V114 formulation.
Outcome measures
| Measure |
Adult V114: 1x:1x:1x
n=51 Participants
On Day 1, adults receive a single vaccination of V114 1x:1x:1x (containing 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 4.0 μg of polysaccharide serotype 6B; and 125 µg of APA).
|
Adult V114: 2x.2x.2x
n=51 Participants
On Day 1, adults receive a single vaccination of V114 2x:2x:2x (containing 4.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 8.0 μg of polysaccharide serotype 6B; and 250 µg of APA).
|
Infant V114: 2x:2x:2x
Infants receive 4 total V114: 2x:2x:2x (containing 4.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 8.0 μg of polysaccharide serotype 6B; and 250 µg of APA) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
Infant V114: 0.5x:0.5x:2x
Infants receive 4 total V114 0.5x:0.5x:2x (containing 1.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 2.0 μg of polysaccharide serotype 6B; and 250 µg of APA) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
Infant V114: 1x:1x:2x
Infants receive 4 total V114 1x:1x:2x (containing 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 4.0 μg of polysaccharide serotype 6B; and 250 µg of APA) total vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
Infant Prevnar 13®
Infants receive 4 total Prevnar 13® (containing 2.2 µg of pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, and 23F; and 4.4 µg of serotype 6B) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
|---|---|---|---|---|---|---|
|
Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 2x:1x:2x vs Prenar 13®
PT18C
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
|
Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 2x:1x:2x vs Prenar 13®
PT19A
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
|
Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 2x:1x:2x vs Prenar 13®
non-PT33F
|
95.7 Percentage of Participants
|
2.7 Percentage of Participants
|
—
|
—
|
—
|
—
|
|
Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 2x:1x:2x vs Prenar 13®
PT1
|
95.8 Percentage of Participants
|
100.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
|
Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 2x:1x:2x vs Prenar 13®
PT3
|
87.5 Percentage of Participants
|
75.7 Percentage of Participants
|
—
|
—
|
—
|
—
|
|
Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 2x:1x:2x vs Prenar 13®
PT4
|
95.7 Percentage of Participants
|
97.3 Percentage of Participants
|
—
|
—
|
—
|
—
|
|
Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 2x:1x:2x vs Prenar 13®
PT5
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
|
Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 2x:1x:2x vs Prenar 13®
PT6A
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
|
Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 2x:1x:2x vs Prenar 13®
PT6B
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
|
Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 2x:1x:2x vs Prenar 13®
PT7F
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
|
Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 2x:1x:2x vs Prenar 13®
PT9V
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
|
Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 2x:1x:2x vs Prenar 13®
PT14
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
|
Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 2x:1x:2x vs Prenar 13®
PT19F
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
|
Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 2x:1x:2x vs Prenar 13®
PT23F
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
|
Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 2x:1x:2x vs Prenar 13®
non-PT22F
|
95.8 Percentage of Participants
|
10.8 Percentage of Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: One month following the 4th vaccination (approximately 13 to 16 months of age).Population: Randomized and treated infants with results available for the outcome measure and no protocol violations are included.
The percentage of infant participants with antibody responses meeting the World Health Organization (WHO)-accepted threshold value of ≥0.35 μg/mL was determined for each Prevnar 13®-type (PT) or non-Prevnar 13®-type (non-PT) pneumococcal serotype. Antibody levels were determined with the pneumococcal electrochemiluminescence (Pn ECL) assay for each V114 formulation.
Outcome measures
| Measure |
Adult V114: 1x:1x:1x
n=50 Participants
On Day 1, adults receive a single vaccination of V114 1x:1x:1x (containing 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 4.0 μg of polysaccharide serotype 6B; and 125 µg of APA).
|
Adult V114: 2x.2x.2x
n=51 Participants
On Day 1, adults receive a single vaccination of V114 2x:2x:2x (containing 4.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 8.0 μg of polysaccharide serotype 6B; and 250 µg of APA).
|
Infant V114: 2x:2x:2x
Infants receive 4 total V114: 2x:2x:2x (containing 4.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 8.0 μg of polysaccharide serotype 6B; and 250 µg of APA) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
Infant V114: 0.5x:0.5x:2x
Infants receive 4 total V114 0.5x:0.5x:2x (containing 1.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 2.0 μg of polysaccharide serotype 6B; and 250 µg of APA) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
Infant V114: 1x:1x:2x
Infants receive 4 total V114 1x:1x:2x (containing 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 4.0 μg of polysaccharide serotype 6B; and 250 µg of APA) total vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
Infant Prevnar 13®
Infants receive 4 total Prevnar 13® (containing 2.2 µg of pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, and 23F; and 4.4 µg of serotype 6B) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
|---|---|---|---|---|---|---|
|
Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 2x:2x:2x vs Prenar 13®
PT7F
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
|
Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 2x:2x:2x vs Prenar 13®
non-PT22F
|
100.0 Percentage of Participants
|
10.8 Percentage of Participants
|
—
|
—
|
—
|
—
|
|
Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 2x:2x:2x vs Prenar 13®
PT1
|
97.0 Percentage of Participants
|
100.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
|
Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 2x:2x:2x vs Prenar 13®
PT3
|
100.0 Percentage of Participants
|
75.7 Percentage of Participants
|
—
|
—
|
—
|
—
|
|
Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 2x:2x:2x vs Prenar 13®
PT4
|
100.0 Percentage of Participants
|
97.3 Percentage of Participants
|
—
|
—
|
—
|
—
|
|
Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 2x:2x:2x vs Prenar 13®
PT5
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
|
Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 2x:2x:2x vs Prenar 13®
PT6A
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
|
Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 2x:2x:2x vs Prenar 13®
PT6B
|
97.0 Percentage of Participants
|
100.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
|
Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 2x:2x:2x vs Prenar 13®
PT9V
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
|
Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 2x:2x:2x vs Prenar 13®
PT14
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
|
Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 2x:2x:2x vs Prenar 13®
PT18C
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
|
Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 2x:2x:2x vs Prenar 13®
PT19A
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
|
Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 2x:2x:2x vs Prenar 13®
PT19F
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
|
Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 2x:2x:2x vs Prenar 13®
PT23F
|
97.0 Percentage of Participants
|
100.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
|
Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 2x:2x:2x vs Prenar 13®
non-PT33F
|
100.0 Percentage of Participants
|
2.7 Percentage of Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: One month following the 4th vaccination (approximately 13 to 16 months of age).Population: Randomized and treated infants with results available for the outcome measure and no protocol violations are included.
The percentage of infant participants with antibody responses meeting the World Health Organization (WHO)-accepted threshold value of ≥0.35 μg/mL was determined for each Prevnar 13®-type (PT) or non-Prevnar 13®-type (non-PT) pneumococcal serotype. Antibody levels were determined with the pneumococcal electrochemiluminescence (Pn ECL) assay for each V114 formulation.
Outcome measures
| Measure |
Adult V114: 1x:1x:1x
n=48 Participants
On Day 1, adults receive a single vaccination of V114 1x:1x:1x (containing 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 4.0 μg of polysaccharide serotype 6B; and 125 µg of APA).
|
Adult V114: 2x.2x.2x
n=51 Participants
On Day 1, adults receive a single vaccination of V114 2x:2x:2x (containing 4.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 8.0 μg of polysaccharide serotype 6B; and 250 µg of APA).
|
Infant V114: 2x:2x:2x
Infants receive 4 total V114: 2x:2x:2x (containing 4.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 8.0 μg of polysaccharide serotype 6B; and 250 µg of APA) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
Infant V114: 0.5x:0.5x:2x
Infants receive 4 total V114 0.5x:0.5x:2x (containing 1.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 2.0 μg of polysaccharide serotype 6B; and 250 µg of APA) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
Infant V114: 1x:1x:2x
Infants receive 4 total V114 1x:1x:2x (containing 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 4.0 μg of polysaccharide serotype 6B; and 250 µg of APA) total vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
Infant Prevnar 13®
Infants receive 4 total Prevnar 13® (containing 2.2 µg of pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, and 23F; and 4.4 µg of serotype 6B) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
|---|---|---|---|---|---|---|
|
Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 0.5x:0.5x:2x vs Prenar 13®
PT18C
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
|
Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 0.5x:0.5x:2x vs Prenar 13®
PT1
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
|
Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 0.5x:0.5x:2x vs Prenar 13®
PT3
|
94.1 Percentage of Participants
|
75.7 Percentage of Participants
|
—
|
—
|
—
|
—
|
|
Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 0.5x:0.5x:2x vs Prenar 13®
PT4
|
82.4 Percentage of Participants
|
97.3 Percentage of Participants
|
—
|
—
|
—
|
—
|
|
Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 0.5x:0.5x:2x vs Prenar 13®
PT5
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
|
Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 0.5x:0.5x:2x vs Prenar 13®
PT6A
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
|
Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 0.5x:0.5x:2x vs Prenar 13®
PT6B
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
|
Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 0.5x:0.5x:2x vs Prenar 13®
PT7F
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
|
Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 0.5x:0.5x:2x vs Prenar 13®
PT9V
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
|
Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 0.5x:0.5x:2x vs Prenar 13®
PT14
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
|
Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 0.5x:0.5x:2x vs Prenar 13®
PT19A
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
|
Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 0.5x:0.5x:2x vs Prenar 13®
PT19F
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
|
Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 0.5x:0.5x:2x vs Prenar 13®
PT23F
|
94.1 Percentage of Participants
|
100.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
|
Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 0.5x:0.5x:2x vs Prenar 13®
non-PT22F
|
100.0 Percentage of Participants
|
10.8 Percentage of Participants
|
—
|
—
|
—
|
—
|
|
Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 0.5x:0.5x:2x vs Prenar 13®
non-PT33F
|
100.0 Percentage of Participants
|
2.7 Percentage of Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: One month following the 4th vaccination (approximately 13 to 16 months of age).Population: Randomized and treated infants with results available for the outcome measure and no protocol violations are included.
The percentage of infant participants with antibody responses meeting the World Health Organization (WHO)-accepted threshold value of ≥0.35 μg/mL was determined for each Prevnar 13®-type (PT) or non-Prevnar 13®-type (non-PT) pneumococcal serotype. Antibody levels were determined with the pneumococcal electrochemiluminescence (Pn ECL) assay for each V114 formulation.
Outcome measures
| Measure |
Adult V114: 1x:1x:1x
n=50 Participants
On Day 1, adults receive a single vaccination of V114 1x:1x:1x (containing 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 4.0 μg of polysaccharide serotype 6B; and 125 µg of APA).
|
Adult V114: 2x.2x.2x
n=51 Participants
On Day 1, adults receive a single vaccination of V114 2x:2x:2x (containing 4.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 8.0 μg of polysaccharide serotype 6B; and 250 µg of APA).
|
Infant V114: 2x:2x:2x
Infants receive 4 total V114: 2x:2x:2x (containing 4.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 8.0 μg of polysaccharide serotype 6B; and 250 µg of APA) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
Infant V114: 0.5x:0.5x:2x
Infants receive 4 total V114 0.5x:0.5x:2x (containing 1.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 2.0 μg of polysaccharide serotype 6B; and 250 µg of APA) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
Infant V114: 1x:1x:2x
Infants receive 4 total V114 1x:1x:2x (containing 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 4.0 μg of polysaccharide serotype 6B; and 250 µg of APA) total vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
Infant Prevnar 13®
Infants receive 4 total Prevnar 13® (containing 2.2 µg of pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, and 23F; and 4.4 µg of serotype 6B) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
|---|---|---|---|---|---|---|
|
Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 1x:1x:2x vs Prenar 13®
PT23F
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
|
Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 1x:1x:2x vs Prenar 13®
PT1
|
96.6 Percentage of Participants
|
100.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
|
Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 1x:1x:2x vs Prenar 13®
PT3
|
89.7 Percentage of Participants
|
75.7 Percentage of Participants
|
—
|
—
|
—
|
—
|
|
Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 1x:1x:2x vs Prenar 13®
PT4
|
89.7 Percentage of Participants
|
97.3 Percentage of Participants
|
—
|
—
|
—
|
—
|
|
Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 1x:1x:2x vs Prenar 13®
PT5
|
96.6 Percentage of Participants
|
100.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
|
Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 1x:1x:2x vs Prenar 13®
PT6A
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
|
Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 1x:1x:2x vs Prenar 13®
PT6B
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
|
Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 1x:1x:2x vs Prenar 13®
PT7F
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
|
Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 1x:1x:2x vs Prenar 13®
PT9V
|
96.6 Percentage of Participants
|
100.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
|
Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 1x:1x:2x vs Prenar 13®
PT14
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
|
Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 1x:1x:2x vs Prenar 13®
PT18C
|
96.6 Percentage of Participants
|
100.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
|
Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 1x:1x:2x vs Prenar 13®
PT19A
|
93.1 Percentage of Participants
|
100.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
|
Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 1x:1x:2x vs Prenar 13®
PT19F
|
96.6 Percentage of Participants
|
100.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
|
Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 1x:1x:2x vs Prenar 13®
non-PT22F
|
100.0 Percentage of Participants
|
10.8 Percentage of Participants
|
—
|
—
|
—
|
—
|
|
Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 1x:1x:2x vs Prenar 13®
non-PT33F
|
96.6 Percentage of Participants
|
2.7 Percentage of Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: One month following the 4th vaccination (approximately 13 to 16 months of age)Population: Randomized and treated infants with results available for the outcome measure and no protocol violations are included.
The IgG antibody GMCs of each Prevnar 13®-type (PT) or non-Prevnar 13® type (non-PT) serotype at 1 month PD4 following V114 or Prevnar 13® treatment were determined with the pneumococcal electrochemiluminescence (Pn ECL) assay.
Outcome measures
| Measure |
Adult V114: 1x:1x:1x
n=50 Participants
On Day 1, adults receive a single vaccination of V114 1x:1x:1x (containing 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 4.0 μg of polysaccharide serotype 6B; and 125 µg of APA).
|
Adult V114: 2x.2x.2x
n=51 Participants
On Day 1, adults receive a single vaccination of V114 2x:2x:2x (containing 4.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 8.0 μg of polysaccharide serotype 6B; and 250 µg of APA).
|
Infant V114: 2x:2x:2x
n=50 Participants
Infants receive 4 total V114: 2x:2x:2x (containing 4.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 8.0 μg of polysaccharide serotype 6B; and 250 µg of APA) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
Infant V114: 0.5x:0.5x:2x
n=48 Participants
Infants receive 4 total V114 0.5x:0.5x:2x (containing 1.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 2.0 μg of polysaccharide serotype 6B; and 250 µg of APA) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
Infant V114: 1x:1x:2x
n=50 Participants
Infants receive 4 total V114 1x:1x:2x (containing 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 4.0 μg of polysaccharide serotype 6B; and 250 µg of APA) total vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
Infant Prevnar 13®
n=51 Participants
Infants receive 4 total Prevnar 13® (containing 2.2 µg of pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, and 23F; and 4.4 µg of serotype 6B) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
|---|---|---|---|---|---|---|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants
PT5
|
2.31 µg/mL
Interval 1.66 to 3.22
|
2.46 µg/mL
Interval 1.76 to 3.43
|
3.61 µg/mL
Interval 2.88 to 4.52
|
2.38 µg/mL
Interval 1.72 to 3.3
|
2.50 µg/mL
Interval 1.73 to 3.61
|
4.72 µg/mL
Interval 3.8 to 5.86
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants
PT6A
|
6.93 µg/mL
Interval 4.69 to 10.22
|
9.62 µg/mL
Interval 6.96 to 13.31
|
6.16 µg/mL
Interval 4.55 to 8.34
|
7.88 µg/mL
Interval 5.84 to 10.64
|
6.58 µg/mL
Interval 4.5 to 9.6
|
10.31 µg/mL
Interval 8.22 to 12.92
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants
PT6B
|
7.35 µg/mL
Interval 4.96 to 10.88
|
8.89 µg/mL
Interval 5.87 to 13.46
|
6.31 µg/mL
Interval 4.62 to 8.61
|
7.27 µg/mL
Interval 5.4 to 9.77
|
6.53 µg/mL
Interval 4.57 to 9.34
|
11.55 µg/mL
Interval 9.3 to 14.35
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants
PT14
|
8.68 µg/mL
Interval 5.89 to 12.8
|
7.83 µg/mL
Interval 5.48 to 11.2
|
9.40 µg/mL
Interval 6.47 to 13.65
|
8.48 µg/mL
Interval 6.28 to 11.45
|
7.15 µg/mL
Interval 5.15 to 9.93
|
7.48 µg/mL
Interval 5.79 to 9.67
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants
PT18C
|
2.06 µg/mL
Interval 1.54 to 2.77
|
2.82 µg/mL
Interval 2.13 to 3.72
|
2.95 µg/mL
Interval 2.32 to 3.75
|
2.21 µg/mL
Interval 1.7 to 2.87
|
1.82 µg/mL
Interval 1.3 to 2.56
|
2.84 µg/mL
Interval 2.31 to 3.47
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants
PT19A
|
3.65 µg/mL
Interval 2.69 to 4.95
|
5.34 µg/mL
Interval 3.79 to 7.53
|
6.54 µg/mL
Interval 4.77 to 8.96
|
3.46 µg/mL
Interval 2.48 to 4.81
|
5.86 µg/mL
Interval 4.17 to 8.23
|
5.11 µg/mL
Interval 4.19 to 6.23
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants
PT19F
|
6.07 µg/mL
Interval 4.4 to 8.37
|
9.72 µg/mL
Interval 7.28 to 12.99
|
9.11 µg/mL
Interval 7.0 to 11.84
|
4.38 µg/mL
Interval 3.2 to 5.98
|
5.86 µg/mL
Interval 4.17 to 8.23
|
5.11 µg/mL
Interval 4.19 to 6.23
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants
PT23F
|
2.01 µg/mL
Interval 1.43 to 2.83
|
2.60 µg/mL
Interval 1.84 to 3.67
|
2.95 µg/mL
Interval 2.26 to 3.86
|
2.00 µg/mL
Interval 1.36 to 2.94
|
2.02 µg/mL
Interval 1.44 to 2.83
|
3.91 µg/mL
Interval 3.03 to 5.05
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants
PT7F
|
4.69 µg/mL
Interval 3.44 to 6.4
|
3.00 µg/mL
Interval 2.29 to 3.92
|
5.24 µg/mL
Interval 3.94 to 6.99
|
4.65 µg/mL
Interval 3.26 to 6.63
|
4.39 µg/mL
Interval 3.33 to 5.79
|
5.65 µg/mL
Interval 4.65 to 6.88
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants
PT9V
|
2.96 µg/mL
Interval 2.01 to 4.36
|
2.20 µg/mL
Interval 1.56 to 3.1
|
3.18 µg/mL
Interval 2.47 to 4.08
|
2.83 µg/mL
Interval 2.08 to 3.84
|
2.27 µg/mL
Interval 1.57 to 3.27
|
3.25 µg/mL
Interval 2.47 to 4.29
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants
PT1
|
1.67 µg/mL
Interval 1.16 to 2.41
|
1.85 µg/mL
Interval 1.2 to 2.86
|
2.25 µg/mL
Interval 1.79 to 2.82
|
1.62 µg/mL
Interval 1.27 to 2.05
|
1.67 µg/mL
Interval 1.22 to 2.28
|
2.33 µg/mL
Interval 1.84 to 2.95
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants
PT3
|
1.10 µg/mL
Interval 0.81 to 1.51
|
0.96 µg/mL
Interval 0.69 to 1.33
|
1.69 µg/mL
Interval 1.4 to 2.03
|
1.06 µg/mL
Interval 0.79 to 1.41
|
1.09 µg/mL
Interval 0.77 to 1.52
|
0.62 µg/mL
Interval 0.49 to 0.77
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants
PT4
|
1.71 µg/mL
Interval 1.21 to 2.41
|
1.60 µg/mL
Interval 1.07 to 2.39
|
2.46 µg/mL
Interval 1.8 to 3.36
|
1.21 µg/mL
Interval 0.82 to 1.78
|
1.39 µg/mL
Interval 0.97 to 1.98
|
1.78 µg/mL
Interval 1.33 to 2.39
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants
non-PT22F
|
7.21 µg/mL
Interval 4.99 to 10.4
|
5.05 µg/mL
Interval 3.13 to 8.14
|
10.66 µg/mL
Interval 7.74 to 14.69
|
6.78 µg/mL
Interval 5.06 to 9.09
|
7.88 µg/mL
Interval 5.92 to 10.48
|
0.08 µg/mL
Interval 0.06 to 0.12
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants
non-PT33F
|
6.44 µg/mL
Interval 4.51 to 9.21
|
3.93 µg/mL
Interval 2.24 to 6.88
|
8.03 µg/mL
Interval 5.94 to 10.86
|
6.85 µg/mL
Interval 4.98 to 9.42
|
5.07 µg/mL
Interval 3.46 to 7.42
|
0.07 µg/mL
Interval 0.05 to 0.09
|
SECONDARY outcome
Timeframe: Month 2 (1 month after a single vaccination)Population: Randomized and treated adults with results available for the outcome measure and no protocol violations are included.
The IgG antibody GMCs of each Prevnar 13®-type (PT) or non-Prevnar 13® type (non-PT) serotype at 1 month after a single vaccination with V114 were determined with the pneumococcal electrochemiluminescence (Pn ECL) assay. Data reflect the GMC of each serotype.
Outcome measures
| Measure |
Adult V114: 1x:1x:1x
n=20 Participants
On Day 1, adults receive a single vaccination of V114 1x:1x:1x (containing 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 4.0 μg of polysaccharide serotype 6B; and 125 µg of APA).
|
Adult V114: 2x.2x.2x
n=20 Participants
On Day 1, adults receive a single vaccination of V114 2x:2x:2x (containing 4.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 8.0 μg of polysaccharide serotype 6B; and 250 µg of APA).
|
Infant V114: 2x:2x:2x
Infants receive 4 total V114: 2x:2x:2x (containing 4.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 8.0 μg of polysaccharide serotype 6B; and 250 µg of APA) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
Infant V114: 0.5x:0.5x:2x
Infants receive 4 total V114 0.5x:0.5x:2x (containing 1.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 2.0 μg of polysaccharide serotype 6B; and 250 µg of APA) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
Infant V114: 1x:1x:2x
Infants receive 4 total V114 1x:1x:2x (containing 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 4.0 μg of polysaccharide serotype 6B; and 250 µg of APA) total vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
Infant Prevnar 13®
Infants receive 4 total Prevnar 13® (containing 2.2 µg of pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, and 23F; and 4.4 µg of serotype 6B) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
|---|---|---|---|---|---|---|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults
PT6A
|
8.23 µg/mL
Interval 4.26 to 15.86
|
3.52 µg/mL
Interval 1.48 to 8.36
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults
PT6B
|
8.96 µg/mL
Interval 4.15 to 19.34
|
4.08 µg/mL
Interval 1.61 to 10.35
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults
PT9V
|
4.96 µg/mL
Interval 2.33 to 10.56
|
2.96 µg/mL
Interval 1.7 to 5.15
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults
PT14
|
16.24 µg/mL
Interval 7.42 to 35.54
|
18.45 µg/mL
Interval 7.56 to 45.02
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults
PT19A
|
9.71 µg/mL
Interval 4.98 to 18.94
|
4.39 µg/mL
Interval 2.29 to 8.42
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults
PT19F
|
3.39 µg/mL
Interval 1.61 to 7.15
|
3.71 µg/mL
Interval 1.7 to 8.09
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults
non-PT23F
|
4.78 µg/mL
Interval 2.03 to 11.26
|
3.32 µg/mL
Interval 1.49 to 7.38
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults
non-PT33F
|
3.41 µg/mL
Interval 1.64 to 7.08
|
4.69 µg/mL
Interval 1.51 to 14.53
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults
PT1
|
3.19 µg/mL
Interval 1.71 to 5.97
|
5.82 µg/mL
Interval 3.34 to 10.15
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults
PT3
|
0.84 µg/mL
Interval 0.47 to 1.47
|
1.12 µg/mL
Interval 0.62 to 2.03
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults
PT4
|
2.28 µg/mL
Interval 1.25 to 4.18
|
1.80 µg/mL
Interval 1.08 to 2.99
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults
PT5
|
2.63 µg/mL
Interval 1.01 to 6.84
|
1.90 µg/mL
Interval 1.02 to 3.52
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults
PT7F
|
4.88 µg/mL
Interval 2.22 to 10.75
|
2.20 µg/mL
Interval 1.01 to 4.8
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults
PT18C
|
4.56 µg/mL
Interval 2.32 to 8.98
|
2.63 µg/mL
Interval 1.52 to 4.56
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults
PT22F
|
6.05 µg/mL
Interval 2.66 to 13.75
|
7.81 µg/mL
Interval 3.84 to 15.87
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Month 2 (1 month after a single vaccination)Population: Randomized and treated adults with results available for the outcome measure and no protocol violations are included.
The percentage of participants with ≥4-fold-rise from baseline in each Prevnar 13®-type (PT) or non-Prevnar 13® type (non-PT) serotype at 1 month after a single vaccination with V114 were determined with the pneumococcal electrochemiluminescence (Pn ECL) assay.
Outcome measures
| Measure |
Adult V114: 1x:1x:1x
n=20 Participants
On Day 1, adults receive a single vaccination of V114 1x:1x:1x (containing 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 4.0 μg of polysaccharide serotype 6B; and 125 µg of APA).
|
Adult V114: 2x.2x.2x
n=20 Participants
On Day 1, adults receive a single vaccination of V114 2x:2x:2x (containing 4.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 8.0 μg of polysaccharide serotype 6B; and 250 µg of APA).
|
Infant V114: 2x:2x:2x
Infants receive 4 total V114: 2x:2x:2x (containing 4.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 8.0 μg of polysaccharide serotype 6B; and 250 µg of APA) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
Infant V114: 0.5x:0.5x:2x
Infants receive 4 total V114 0.5x:0.5x:2x (containing 1.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 2.0 μg of polysaccharide serotype 6B; and 250 µg of APA) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
Infant V114: 1x:1x:2x
Infants receive 4 total V114 1x:1x:2x (containing 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 4.0 μg of polysaccharide serotype 6B; and 250 µg of APA) total vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
Infant Prevnar 13®
Infants receive 4 total Prevnar 13® (containing 2.2 µg of pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, and 23F; and 4.4 µg of serotype 6B) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With ≥4-fold-rise From Baseline in Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults
PT1
|
93.75 Percentage of Participants
Interval 69.77 to 99.84
|
100.00 Percentage of Participants
Interval 81.47 to 100.0
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With ≥4-fold-rise From Baseline in Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults
PT3
|
56.25 Percentage of Participants
Interval 29.88 to 80.25
|
66.67 Percentage of Participants
Interval 40.99 to 86.66
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With ≥4-fold-rise From Baseline in Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults
PT4
|
93.75 Percentage of Participants
Interval 69.77 to 99.84
|
88.89 Percentage of Participants
Interval 65.29 to 98.62
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With ≥4-fold-rise From Baseline in Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults
PT5
|
50.00 Percentage of Participants
Interval 24.65 to 75.35
|
61.11 Percentage of Participants
Interval 35.75 to 82.7
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With ≥4-fold-rise From Baseline in Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults
PT9V
|
100.00 Percentage of Participants
Interval 79.41 to 100.0
|
88.89 Percentage of Participants
Interval 65.29 to 98.62
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With ≥4-fold-rise From Baseline in Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults
PT14
|
87.50 Percentage of Participants
Interval 61.65 to 98.45
|
83.33 Percentage of Participants
Interval 58.58 to 96.42
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With ≥4-fold-rise From Baseline in Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults
PT18C
|
87.50 Percentage of Participants
Interval 61.65 to 98.45
|
72.22 Percentage of Participants
Interval 46.52 to 90.31
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With ≥4-fold-rise From Baseline in Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults
PT19A
|
81.25 Percentage of Participants
Interval 54.35 to 95.95
|
55.56 Percentage of Participants
Interval 30.76 to 78.47
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With ≥4-fold-rise From Baseline in Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults
PT19F
|
81.25 Percentage of Participants
Interval 54.35 to 95.95
|
83.33 Percentage of Participants
Interval 58.58 to 96.42
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With ≥4-fold-rise From Baseline in Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults
PT22F
|
93.75 Percentage of Participants
Interval 69.77 to 99.84
|
83.33 Percentage of Participants
Interval 58.58 to 96.42
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With ≥4-fold-rise From Baseline in Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults
non-PT23F
|
87.50 Percentage of Participants
Interval 61.65 to 98.45
|
77.78 Percentage of Participants
Interval 52.36 to 93.59
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With ≥4-fold-rise From Baseline in Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults
non-PT33F
|
62.50 Percentage of Participants
Interval 35.43 to 84.8
|
66.67 Percentage of Participants
Interval 40.99 to 86.66
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With ≥4-fold-rise From Baseline in Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults
PT6A
|
81.25 Percentage of Participants
Interval 54.35 to 95.95
|
72.22 Percentage of Participants
Interval 46.52 to 90.31
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With ≥4-fold-rise From Baseline in Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults
PT6B
|
100.00 Percentage of Participants
Interval 79.41 to 100.0
|
83.33 Percentage of Participants
Interval 58.58 to 96.42
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With ≥4-fold-rise From Baseline in Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults
PT7F
|
81.25 Percentage of Participants
Interval 54.35 to 95.95
|
44.44 Percentage of Participants
Interval 21.53 to 69.24
|
—
|
—
|
—
|
—
|
Adverse Events
Adult: V114-1x:1x:1x
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Adult: V114-2x:2x:2x
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Infant: V114-1x:1x:1x
Serious events: 1 serious events
Other events: 49 other events
Deaths: 0 deaths
Infant: V114-2x:1x:2x
Serious events: 4 serious events
Other events: 51 other events
Deaths: 0 deaths
Infant: V114-2x:2x:2x
Serious events: 3 serious events
Other events: 48 other events
Deaths: 0 deaths
Infant: V114-0.5x:0.5x:2x
Serious events: 3 serious events
Other events: 46 other events
Deaths: 0 deaths
Infant: V114-1x:1x:2x
Serious events: 0 serious events
Other events: 49 other events
Deaths: 0 deaths
Infant: Prevnar 13
Serious events: 5 serious events
Other events: 50 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Adult: V114-1x:1x:1x
n=20 participants at risk
On Day 1, adults receive a single vaccination of V114 1x:1x:1x (containing 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 4.0 μg of polysaccharide serotype 6B; and 125 µg of APA).
|
Adult: V114-2x:2x:2x
n=20 participants at risk
On Day 1, adults receive a single vaccination of V114 2x:2x:2x (containing 4.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 8.0 μg of polysaccharide serotype 6B; and 250 µg of APA).
|
Infant: V114-1x:1x:1x
n=50 participants at risk
Infants receive 4 total V114: 1x:1x:1x (containing 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 4.0 μg of polysaccharide serotype 6B; and 125 µg of APA) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
Infant: V114-2x:1x:2x
n=51 participants at risk
Infants receive 4 total V114: 2x:1x:2x (containing 4.0 μg of polysaccharide serotypes 6A, 18C, 19A, 19F, and 23F; 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 7F, 9V, 14, 22F, and 33F; 8.0 μg of polysaccharide serotype 6B; and 250 µg of APA) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
Infant: V114-2x:2x:2x
n=50 participants at risk
Infants receive 4 total V114: 2x:2x:2x (containing 4.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 8.0 μg of polysaccharide serotype 6B; and 250 µg of APA) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
Infant: V114-0.5x:0.5x:2x
n=48 participants at risk
Infants receive 4 total V114 0.5x:0.5x:2x (containing 1.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 2.0 μg of polysaccharide serotype 6B; and 250 µg of APA) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
Infant: V114-1x:1x:2x
n=50 participants at risk
Infants receive 4 total V114 1x:1x:2x (containing 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 4.0 μg of polysaccharide serotype 6B; and 250 µg of APA) total vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
Infant: Prevnar 13
n=51 participants at risk
Infants receive 4 total Prevnar 13® (containing 2.2 µg of pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, and 23F; and 4.4 µg of serotype 6B) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.1%
1/48 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Infections and infestations
Abdominal wall abscess
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/51 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Infections and infestations
Abscess neck
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/51 • Number of events 2 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/51 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/51 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
4.0%
2/50 • Number of events 2 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/51 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/50 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/51 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Infections and infestations
Oral viral infection
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/51 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/51 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Infections and infestations
Respiratory syncytial virus bronchiolitis
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/51 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/51 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Infections and infestations
Viral infection
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
4.0%
2/50 • Number of events 2 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/51 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/51 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/51 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/51 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/51 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.1%
1/48 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/51 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.1%
1/48 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
Other adverse events
| Measure |
Adult: V114-1x:1x:1x
n=20 participants at risk
On Day 1, adults receive a single vaccination of V114 1x:1x:1x (containing 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 4.0 μg of polysaccharide serotype 6B; and 125 µg of APA).
|
Adult: V114-2x:2x:2x
n=20 participants at risk
On Day 1, adults receive a single vaccination of V114 2x:2x:2x (containing 4.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 8.0 μg of polysaccharide serotype 6B; and 250 µg of APA).
|
Infant: V114-1x:1x:1x
n=50 participants at risk
Infants receive 4 total V114: 1x:1x:1x (containing 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 4.0 μg of polysaccharide serotype 6B; and 125 µg of APA) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
Infant: V114-2x:1x:2x
n=51 participants at risk
Infants receive 4 total V114: 2x:1x:2x (containing 4.0 μg of polysaccharide serotypes 6A, 18C, 19A, 19F, and 23F; 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 7F, 9V, 14, 22F, and 33F; 8.0 μg of polysaccharide serotype 6B; and 250 µg of APA) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
Infant: V114-2x:2x:2x
n=50 participants at risk
Infants receive 4 total V114: 2x:2x:2x (containing 4.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 8.0 μg of polysaccharide serotype 6B; and 250 µg of APA) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
Infant: V114-0.5x:0.5x:2x
n=48 participants at risk
Infants receive 4 total V114 0.5x:0.5x:2x (containing 1.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 2.0 μg of polysaccharide serotype 6B; and 250 µg of APA) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
Infant: V114-1x:1x:2x
n=50 participants at risk
Infants receive 4 total V114 1x:1x:2x (containing 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 4.0 μg of polysaccharide serotype 6B; and 250 µg of APA) total vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
Infant: Prevnar 13
n=51 participants at risk
Infants receive 4 total Prevnar 13® (containing 2.2 µg of pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, and 23F; and 4.4 µg of serotype 6B) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
|---|---|---|---|---|---|---|---|---|
|
General disorders
Chills
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
5.0%
1/20 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
General disorders
Fatigue
|
45.0%
9/20 • Number of events 10 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
40.0%
8/20 • Number of events 12 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
General disorders
Gait disturbance
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/50 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
General disorders
Injection site bruising
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
8.0%
4/50 • Number of events 4 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
5.9%
3/51 • Number of events 3 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
6.0%
3/50 • Number of events 3 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
6.0%
3/50 • Number of events 4 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
5.9%
3/51 • Number of events 3 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
General disorders
Injection site erythema
|
35.0%
7/20 • Number of events 8 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
30.0%
6/20 • Number of events 6 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
44.0%
22/50 • Number of events 48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
64.7%
33/51 • Number of events 60 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
52.0%
26/50 • Number of events 51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
60.4%
29/48 • Number of events 56 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
56.0%
28/50 • Number of events 47 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
52.9%
27/51 • Number of events 50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Cardiac disorders
Pulmonary valve stenosis
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/51 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/50 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Congenital, familial and genetic disorders
Laryngomalacia
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.1%
1/48 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/51 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Congenital, familial and genetic disorders
Plagiocephaly
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/50 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/50 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/50 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/50 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/51 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Eye disorders
Blepharospasm
|
5.0%
1/20 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Eye disorders
Dacryostenosis acquired
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/50 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/50 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Eye disorders
Eye discharge
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/50 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.1%
1/48 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.1%
1/48 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/50 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.0%
1/20 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
4.0%
2/50 • Number of events 2 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Gastrointestinal disorders
Chapped lips
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/51 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
4.0%
2/50 • Number of events 2 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
4.2%
2/48 • Number of events 2 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
4.0%
2/50 • Number of events 2 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
3.9%
2/51 • Number of events 2 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
5.0%
1/20 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
10.0%
5/50 • Number of events 8 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
7.8%
4/51 • Number of events 9 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
8.0%
4/50 • Number of events 4 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
12.5%
6/48 • Number of events 7 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
12.0%
6/50 • Number of events 8 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
3.9%
2/51 • Number of events 2 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/51 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.0%
1/20 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/50 • Number of events 2 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/51 • Number of events 3 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
8.0%
4/50 • Number of events 4 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
3.9%
2/51 • Number of events 3 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/50 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
5.9%
3/51 • Number of events 3 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
4.0%
2/50 • Number of events 2 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
6.2%
3/48 • Number of events 3 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/50 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
3.9%
2/51 • Number of events 2 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
5.9%
3/51 • Number of events 3 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Gastrointestinal disorders
Infantile spitting up
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/50 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/50 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
4.2%
2/48 • Number of events 2 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
4.0%
2/50 • Number of events 2 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Gastrointestinal disorders
Nausea
|
5.0%
1/20 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/50 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Gastrointestinal disorders
Teething
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
8.0%
4/50 • Number of events 6 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
5.9%
3/51 • Number of events 3 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
6.0%
3/50 • Number of events 3 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
10.4%
5/48 • Number of events 9 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/50 • Number of events 2 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
3.9%
2/51 • Number of events 2 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
5.0%
1/20 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
10.0%
5/50 • Number of events 6 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
3.9%
2/51 • Number of events 2 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
4.0%
2/50 • Number of events 2 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
6.2%
3/48 • Number of events 3 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
4.0%
2/50 • Number of events 2 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/51 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
General disorders
Injection site granuloma
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.1%
1/48 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
General disorders
Injection site induration
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
42.0%
21/50 • Number of events 37 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
52.9%
27/51 • Number of events 51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
38.0%
19/50 • Number of events 36 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
54.2%
26/48 • Number of events 50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
36.0%
18/50 • Number of events 33 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
27.5%
14/51 • Number of events 24 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
General disorders
Injection site joint pain
|
5.0%
1/20 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
5.0%
1/20 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
General disorders
Injection site lymphadenopathy
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
5.0%
1/20 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
General disorders
Injection site macule
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/50 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
General disorders
Injection site mass
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/51 • Number of events 2 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
4.0%
2/50 • Number of events 2 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
General disorders
Injection site nodule
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/51 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
4.0%
2/50 • Number of events 2 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/50 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
General disorders
Injection site pain
|
100.0%
20/20 • Number of events 25 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
100.0%
20/20 • Number of events 31 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
94.0%
47/50 • Number of events 104 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
90.2%
46/51 • Number of events 111 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
80.0%
40/50 • Number of events 114 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
77.1%
37/48 • Number of events 101 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
84.0%
42/50 • Number of events 94 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
80.4%
41/51 • Number of events 102 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
General disorders
Injection site pruritus
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
5.0%
1/20 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
General disorders
Injection site reaction
|
5.0%
1/20 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
General disorders
Injection site swelling
|
35.0%
7/20 • Number of events 7 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
30.0%
6/20 • Number of events 6 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
38.0%
19/50 • Number of events 36 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
54.9%
28/51 • Number of events 47 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
42.0%
21/50 • Number of events 30 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
52.1%
25/48 • Number of events 55 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
44.0%
22/50 • Number of events 42 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
39.2%
20/51 • Number of events 32 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
General disorders
Injection site warmth
|
5.0%
1/20 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/51 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.1%
1/48 • Number of events 2 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/51 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
General disorders
Malaise
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/50 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
General disorders
Pain
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
5.0%
1/20 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/51 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/50 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
General disorders
Peripheral swelling
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/50 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
General disorders
Pyrexia
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
15.0%
3/20 • Number of events 3 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
26.0%
13/50 • Number of events 15 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
31.4%
16/51 • Number of events 27 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
34.0%
17/50 • Number of events 31 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
27.1%
13/48 • Number of events 16 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
22.0%
11/50 • Number of events 14 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
25.5%
13/51 • Number of events 24 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
General disorders
Sluggishness
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
5.0%
1/20 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/51 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
6.0%
3/50 • Number of events 3 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/51 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
10.0%
5/50 • Number of events 5 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
4.0%
2/50 • Number of events 2 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/51 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/50 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Infections and infestations
Candida infection
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/51 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
6.2%
3/48 • Number of events 3 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/50 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
3.9%
2/51 • Number of events 2 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/50 • Number of events 2 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.1%
1/48 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/51 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Infections and infestations
Corona virus infection
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/51 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/51 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Infections and infestations
Croup infectious
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
4.0%
2/50 • Number of events 2 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/51 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/50 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Infections and infestations
Enterovirus infection
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/51 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Infections and infestations
Eye infection
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.1%
1/48 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.1%
1/48 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/51 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/51 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
4.2%
2/48 • Number of events 2 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/50 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/50 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
3.9%
2/51 • Number of events 2 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Infections and infestations
Impetigo
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
4.2%
2/48 • Number of events 2 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/50 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Infections and infestations
Influenza
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/51 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.1%
1/48 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Infections and infestations
Injection site abscess
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/50 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/50 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/50 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Infections and infestations
Metapneumovirus infection
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/50 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/50 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
3.9%
2/51 • Number of events 2 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
4.0%
2/50 • Number of events 2 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
4.2%
2/48 • Number of events 2 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
6.0%
3/50 • Number of events 3 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
3.9%
2/51 • Number of events 3 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/50 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/50 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Infections and infestations
Otitis media
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
4.0%
2/50 • Number of events 3 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
9.8%
5/51 • Number of events 5 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
14.0%
7/50 • Number of events 7 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
6.2%
3/48 • Number of events 4 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
4.0%
2/50 • Number of events 2 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
7.8%
4/51 • Number of events 5 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/50 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
10.4%
5/48 • Number of events 5 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/50 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
3.9%
2/51 • Number of events 3 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Infections and infestations
Otitis media chronic
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/50 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/50 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/50 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/50 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/51 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Infections and infestations
Respiratory syncytial virus bronchiolitis
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/50 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
4.0%
2/50 • Number of events 2 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
4.2%
2/48 • Number of events 2 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/50 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
4.0%
2/50 • Number of events 2 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/50 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/51 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/50 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.1%
1/48 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/50 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/51 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/51 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Infections and infestations
Roseola
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
3.9%
2/51 • Number of events 2 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/50 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
3.9%
2/51 • Number of events 2 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/50 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/51 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Infections and infestations
Skin infection
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/51 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
6.0%
3/50 • Number of events 3 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
13.7%
7/51 • Number of events 8 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
14.0%
7/50 • Number of events 7 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
18.8%
9/48 • Number of events 10 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
6.0%
3/50 • Number of events 3 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
9.8%
5/51 • Number of events 5 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Infections and infestations
Viral infection
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
3.9%
2/51 • Number of events 2 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/50 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
4.2%
2/48 • Number of events 2 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/50 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/51 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Infections and infestations
Viral rash
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/50 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
4.2%
2/48 • Number of events 2 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/50 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/50 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/50 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/51 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/51 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.1%
1/48 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Investigations
Body temperature increased
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
4.0%
2/50 • Number of events 2 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/50 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Investigations
Cardiac murmur
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/50 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Investigations
Stool pH decreased
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/50 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Metabolism and nutrition disorders
Abnormal weight gain
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/50 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/51 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Metabolism and nutrition disorders
Cow's milk intolerance
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/51 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/50 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
46.0%
23/50 • Number of events 60 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
60.8%
31/51 • Number of events 67 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
64.0%
32/50 • Number of events 73 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
56.2%
27/48 • Number of events 53 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
52.0%
26/50 • Number of events 53 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
52.9%
27/51 • Number of events 50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/50 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
15.0%
3/20 • Number of events 3 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
30.0%
6/20 • Number of events 10 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Musculoskeletal and connective tissue disorders
Limb mass
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/50 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Musculoskeletal and connective tissue disorders
Lordosis
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/51 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
5.0%
1/20 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
65.0%
13/20 • Number of events 14 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
55.0%
11/20 • Number of events 12 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
5.0%
1/20 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/50 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
4.0%
2/50 • Number of events 2 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.1%
1/48 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Musculoskeletal and connective tissue disorders
Torticollis
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/51 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/51 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/50 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/50 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Nervous system disorders
Developmental coordination disorder
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/51 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Nervous system disorders
Headache
|
45.0%
9/20 • Number of events 14 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
40.0%
8/20 • Number of events 11 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
84.0%
42/50 • Number of events 137 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
84.3%
43/51 • Number of events 126 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
84.0%
42/50 • Number of events 120 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
75.0%
36/48 • Number of events 106 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
74.0%
37/50 • Number of events 101 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
72.5%
37/51 • Number of events 106 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Psychiatric disorders
Abnormal behaviour
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/50 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/50 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
94.0%
47/50 • Number of events 186 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
96.1%
49/51 • Number of events 185 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
94.0%
47/50 • Number of events 189 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
83.3%
40/48 • Number of events 174 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
84.0%
42/50 • Number of events 151 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
92.2%
47/51 • Number of events 158 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Psychiatric disorders
Libido decreased
|
5.0%
1/20 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Psychiatric disorders
Stereotypy
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/51 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Reproductive system and breast disorders
Genital rash
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/51 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/50 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Respiratory, thoracic and mediastinal disorders
Choking
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.1%
1/48 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
5.0%
1/20 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
8.0%
4/50 • Number of events 4 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
5.9%
3/51 • Number of events 3 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
10.0%
5/50 • Number of events 5 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.1%
1/48 • Number of events 2 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
6.0%
3/50 • Number of events 3 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
7.8%
4/51 • Number of events 4 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.1%
1/48 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
5.0%
1/20 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
4.0%
2/50 • Number of events 2 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
3.9%
2/51 • Number of events 2 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
8.0%
4/50 • Number of events 5 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.1%
1/48 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/50 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
3.9%
2/51 • Number of events 2 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/50 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus discomfort
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
5.0%
1/20 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/50 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/51 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.1%
1/48 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/51 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.1%
1/48 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
6.0%
3/50 • Number of events 5 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/51 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
4.0%
2/50 • Number of events 2 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.1%
1/48 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/50 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
5.9%
3/51 • Number of events 3 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/50 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/51 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/50 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Skin and subcutaneous tissue disorders
Acne infantile
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/51 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/50 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/50 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.1%
1/48 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
4.0%
2/50 • Number of events 2 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/51 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
4.0%
2/50 • Number of events 2 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
8.0%
4/50 • Number of events 4 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.1%
1/48 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/50 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/50 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
4.2%
2/48 • Number of events 2 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/51 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Skin and subcutaneous tissue disorders
Eczema infantile
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/51 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
6.0%
3/50 • Number of events 3 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/50 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Skin and subcutaneous tissue disorders
Macule
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/50 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/51 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
3.9%
2/51 • Number of events 5 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
6.0%
3/50 • Number of events 3 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/51 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
4.0%
2/50 • Number of events 2 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
6.2%
3/48 • Number of events 3 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
7.8%
4/51 • Number of events 4 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/51 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/51 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/50 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/50 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Skin and subcutaneous tissue disorders
Seborrhoea
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/50 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/50 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
4.0%
2/50 • Number of events 3 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
11.8%
6/51 • Number of events 7 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
6.0%
3/50 • Number of events 4 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
4.2%
2/48 • Number of events 4 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
4.0%
2/50 • Number of events 2 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
3.9%
2/51 • Number of events 2 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Vascular disorders
Flushing
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/50 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
|
Vascular disorders
Pallor
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/20 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
2.0%
1/51 • Number of events 1 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/48 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/50 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
0.00%
0/51 • Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results.
- Publication restrictions are in place
Restriction type: OTHER