Trial Outcomes & Findings for Immunogenicity and Safety of a Meningococcal Conjugate Vaccine Given Concomitantly With Other Vaccines in Toddlers (NCT NCT03205371)
NCT ID: NCT03205371
Last Updated: 2022-04-05
Results Overview
Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by serum bactericidal assay using human complement (hSBA) assay. Data for this outcome measure was planned to reported for the combined population of Groups 1 and 10, Groups 2 and 11.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1183 participants
Primary outcome timeframe
Day 0 and Day 30 post-vaccination
Results posted on
2022-04-05
Participant Flow
Study participants were enrolled in South Korea, Mexico, the Russian Federation, and Thailand from 07 November 2016 to 13 June 2018.
A total of 1183 participants were enrolled and randomized in the study.
Participant milestones
| Measure |
South Korea(Group1):MenACYW Conjugate +MMR +Varicella Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of Meningococcal Polysaccharide (Serogroups A, C, Y and W) Tetanus Toxoid (MenACYW) Conjugate vaccine, measles-mumps-rubella (MMR) vaccine, and varicella vaccine on Day 0.
|
South Korea (Group 2): MenACYW Conjugate Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
|
South Korea (Group 3): MMR + Varicella Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MMR vaccine and varicella vaccine on Day 0.
|
Thailand (Group 10):MenACYW Conjugate + MMR+ Varicella Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine, MMR vaccine, and varicella vaccine on Day 0.
|
Thailand (Group 11): MenACYW Conjugate Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
|
Thailand (Group 12): MMR + Varicella Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MMR vaccine and varicella vaccine on Day 0.
|
Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine and diphtheria, tetanus, acellular pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type-b (DTaP-IPV-HB-Hib) vaccine on Day 0.
|
Mexico (Group 5): MenACYW Conjugate Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
|
Mexico (Group 6): DTaP-IPV-HB-Hib Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of DTaP-IPV-HB-Hib vaccine on Day 0.
|
Russian Federation (Group7): MenACYW Conjugate + PCV13 Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 15 to 23 months) received single dose of MenACYW Conjugate and pneumococcal Conjugate vaccine (PCV13) on Day 0.
|
Russian Federation (Group 8): MenACYW Conjugate Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 14 months or 16 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
|
Russian Federation (Group 9): PCV13 Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 15 to 23 months) received single dose of PCV13 vaccine on Day 0.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
107
|
53
|
53
|
86
|
42
|
42
|
200
|
100
|
100
|
200
|
100
|
100
|
|
Overall Study
Safety Analysis Set (SafAS)
|
103
|
52
|
53
|
86
|
42
|
42
|
200
|
100
|
100
|
200
|
100
|
99
|
|
Overall Study
Per-protocol Analysis Set (PPAS)
|
92
|
45
|
50
|
85
|
42
|
42
|
155
|
79
|
68
|
196
|
96
|
92
|
|
Overall Study
COMPLETED
|
103
|
52
|
53
|
86
|
42
|
42
|
190
|
97
|
95
|
200
|
100
|
99
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
0
|
0
|
0
|
0
|
10
|
3
|
5
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
South Korea(Group1):MenACYW Conjugate +MMR +Varicella Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of Meningococcal Polysaccharide (Serogroups A, C, Y and W) Tetanus Toxoid (MenACYW) Conjugate vaccine, measles-mumps-rubella (MMR) vaccine, and varicella vaccine on Day 0.
|
South Korea (Group 2): MenACYW Conjugate Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
|
South Korea (Group 3): MMR + Varicella Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MMR vaccine and varicella vaccine on Day 0.
|
Thailand (Group 10):MenACYW Conjugate + MMR+ Varicella Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine, MMR vaccine, and varicella vaccine on Day 0.
|
Thailand (Group 11): MenACYW Conjugate Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
|
Thailand (Group 12): MMR + Varicella Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MMR vaccine and varicella vaccine on Day 0.
|
Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine and diphtheria, tetanus, acellular pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type-b (DTaP-IPV-HB-Hib) vaccine on Day 0.
|
Mexico (Group 5): MenACYW Conjugate Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
|
Mexico (Group 6): DTaP-IPV-HB-Hib Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of DTaP-IPV-HB-Hib vaccine on Day 0.
|
Russian Federation (Group7): MenACYW Conjugate + PCV13 Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 15 to 23 months) received single dose of MenACYW Conjugate and pneumococcal Conjugate vaccine (PCV13) on Day 0.
|
Russian Federation (Group 8): MenACYW Conjugate Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 14 months or 16 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
|
Russian Federation (Group 9): PCV13 Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 15 to 23 months) received single dose of PCV13 vaccine on Day 0.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
1
|
0
|
0
|
0
|
0
|
4
|
0
|
2
|
0
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
5
|
2
|
3
|
0
|
0
|
0
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Immunogenicity and Safety of a Meningococcal Conjugate Vaccine Given Concomitantly With Other Vaccines in Toddlers
Baseline characteristics by cohort
| Measure |
South Korea(Group1):MenACYW Conjugate +MMR+ Varicella Vaccine
n=107 Participants
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine, MMR vaccine, and varicella vaccine on Day 0.
|
South Korea (Group 2): MenACYW Conjugate Vaccine
n=53 Participants
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
|
South Korea (Group 3): MMR + Varicella Vaccine
n=53 Participants
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MMR vaccine and varicella vaccine on Day 0.
|
Thailand (Group 10): MenACYW Conjugate + MMR+Varicella Vaccine
n=86 Participants
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine, MMR vaccine, and varicella vaccine on Day 0.
|
Thailand (Group 11): MenACYW Conjugate Vaccine
n=42 Participants
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
|
Thailand (Group 12): MMR + Varicella Vaccine
n=42 Participants
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MMR vaccine and varicella vaccine on Day 0.
|
Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine
n=200 Participants
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine and DTaP-IPV-HB-Hib vaccine on Day 0.
|
Mexico (Group 5): MenACYW Conjugate Vaccine
n=100 Participants
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
|
Mexico (Group 6): DTaP-IPV-HB-Hib Vaccine
n=100 Participants
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of DTaP-IPV-HB-Hib vaccine on Day 0.
|
Russian Federation (Group7): MenACYW Conjugate + PCV13 Vaccine
n=200 Participants
Healthy, meningococcal-vaccine naïve toddlers (aged 15 to 23 months) received single dose of MenACYW Conjugate vaccine and pneumococcal Conjugate vaccine (PCV13) on Day 0.
|
Russian Federation (Group 8): MenACYW Conjugate Vaccine
n=100 Participants
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 14 months or 16 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
|
Russian Federation (Group 9): PCV13 Vaccine
n=100 Participants
Healthy, meningococcal-vaccine naïve toddlers (aged 15 to 23 months) received single dose of PCV13 vaccine on Day 0.
|
Total
n=1183 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
12.7 months
STANDARD_DEVIATION 1.58 • n=5 Participants
|
12.7 months
STANDARD_DEVIATION 1.50 • n=7 Participants
|
12.3 months
STANDARD_DEVIATION 0.96 • n=5 Participants
|
12.4 months
STANDARD_DEVIATION 0.90 • n=4 Participants
|
12.4 months
STANDARD_DEVIATION 0.88 • n=21 Participants
|
12.8 months
STANDARD_DEVIATION 1.76 • n=8 Participants
|
16.4 months
STANDARD_DEVIATION 2.73 • n=8 Participants
|
16.8 months
STANDARD_DEVIATION 2.83 • n=24 Participants
|
16.8 months
STANDARD_DEVIATION 2.99 • n=42 Participants
|
16.5 months
STANDARD_DEVIATION 2.36 • n=42 Participants
|
16.0 months
STANDARD_DEVIATION 3.10 • n=42 Participants
|
16.3 months
STANDARD_DEVIATION 2.26 • n=42 Participants
|
15.2 months
STANDARD_DEVIATION 2.97 • n=36 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
23 Participants
n=8 Participants
|
93 Participants
n=8 Participants
|
46 Participants
n=24 Participants
|
48 Participants
n=42 Participants
|
78 Participants
n=42 Participants
|
51 Participants
n=42 Participants
|
45 Participants
n=42 Participants
|
550 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
58 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
19 Participants
n=8 Participants
|
107 Participants
n=8 Participants
|
54 Participants
n=24 Participants
|
52 Participants
n=42 Participants
|
122 Participants
n=42 Participants
|
49 Participants
n=42 Participants
|
55 Participants
n=42 Participants
|
633 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
86 Participants
n=4 Participants
|
42 Participants
n=21 Participants
|
42 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
179 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
200 Participants
n=8 Participants
|
100 Participants
n=24 Participants
|
99 Participants
n=42 Participants
|
198 Participants
n=42 Participants
|
99 Participants
n=42 Participants
|
96 Participants
n=42 Participants
|
792 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
106 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
212 Participants
n=36 Participants
|
|
Region of Enrollment
South Korea
|
107 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
213 Participants
n=36 Participants
|
|
Region of Enrollment
Mexico
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
200 Participants
n=8 Participants
|
100 Participants
n=24 Participants
|
100 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
400 Participants
n=36 Participants
|
|
Region of Enrollment
Russia
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
200 Participants
n=42 Participants
|
100 Participants
n=42 Participants
|
100 Participants
n=42 Participants
|
400 Participants
n=36 Participants
|
|
Region of Enrollment
Thailand
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
86 Participants
n=4 Participants
|
42 Participants
n=21 Participants
|
42 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
170 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Day 0 and Day 30 post-vaccinationPopulation: Analysis was performed on PPAS which included participants who received at least one dose of the study vaccine(s), had a valid post-vaccination blood sample result and no protocol deviations. Data for this outcome measure were not planned to be collected and analyzed for Groups 3, 6, 9, and 12.
Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by serum bactericidal assay using human complement (hSBA) assay. Data for this outcome measure was planned to reported for the combined population of Groups 1 and 10, Groups 2 and 11.
Outcome measures
| Measure |
Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine
n=177 Participants
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) from South Korea and Thailand received single dose of MenACYW Conjugate vaccine, MMR vaccine, and varicella vaccine on Day 0.
|
Groups 2 and 11: MenACYW Conjugate Vaccine
n=87 Participants
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) from South Korea and Thailand received single dose of MenACYW Conjugate vaccine on Day 0.
|
Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine
n=155 Participants
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine and DTaP-IPV-HB-Hib vaccine on Day 0.
|
Mexico (Group 5): MenACYW Conjugate Vaccine
n=79 Participants
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
|
Russian Federation (Group 7): MenACYW Conjugate +PCV13 Vaccine
n=196 Participants
Healthy, meningococcal-vaccine naïve toddlers (aged 15 to 23 months) received single dose of MenACYW Conjugate vaccine and PCV13 vaccine on Day 0.
|
Russian Federation (Group 8): MenACYW Conjugate Vaccine
n=96 Participants
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 14 months or 16 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
|
Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine and DTaP-IPV-HB-Hib vaccine on Day 0.
|
Mexico (Group 5): MenACYW Conjugate Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
|
Mexico (Group 6): DTaP-IPV-HB-Hib Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of DTaP-IPV-HB-Hib Vaccine on Day 0.
|
Russian Federation (Group7): MenACYW Conjugate + PCV13 Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 15 to 23 months) received single dose of MenACYW Conjugate vaccine and PCV13 vaccine on Day 0.
|
Russian Federation (Group 8): MenACYW Conjugate Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 14 months or 16 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
|
Russian Federation (Group 9): PCV13 Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 15 to 23 months) received single dose of PCV13 vaccine on Day 0.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Titers of Meningococcal Serogroups A, C, Y, and W Antibodies Following Injection With MenACYW Conjugate Vaccine Administered Alone or Concomitantly With Other Pediatric Vaccines: Groups 1, 2, 4, 5, 7, 8, 10, and 11
Serogroup A: Day 0
|
5.20 titers (1/dilution)
Interval 4.56 to 5.93
|
6.10 titers (1/dilution)
Interval 5.0 to 7.44
|
5.35 titers (1/dilution)
Interval 4.82 to 5.94
|
5.49 titers (1/dilution)
Interval 4.66 to 6.45
|
5.99 titers (1/dilution)
Interval 5.3 to 6.76
|
8.54 titers (1/dilution)
Interval 6.47 to 11.3
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers of Meningococcal Serogroups A, C, Y, and W Antibodies Following Injection With MenACYW Conjugate Vaccine Administered Alone or Concomitantly With Other Pediatric Vaccines: Groups 1, 2, 4, 5, 7, 8, 10, and 11
Serogroup A: Day 30
|
43.9 titers (1/dilution)
Interval 37.4 to 51.6
|
30.0 titers (1/dilution)
Interval 23.1 to 39.0
|
31.4 titers (1/dilution)
Interval 25.9 to 38.1
|
37.8 titers (1/dilution)
Interval 28.5 to 50.2
|
24.6 titers (1/dilution)
Interval 20.2 to 30.1
|
49.0 titers (1/dilution)
Interval 36.8 to 65.3
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers of Meningococcal Serogroups A, C, Y, and W Antibodies Following Injection With MenACYW Conjugate Vaccine Administered Alone or Concomitantly With Other Pediatric Vaccines: Groups 1, 2, 4, 5, 7, 8, 10, and 11
Serogroup C: Day 0
|
2.37 titers (1/dilution)
Interval 2.11 to 2.65
|
2.58 titers (1/dilution)
Interval 2.15 to 3.1
|
2.21 titers (1/dilution)
Interval 2.11 to 2.31
|
2.16 titers (1/dilution)
Interval 2.0 to 2.34
|
2.77 titers (1/dilution)
Interval 2.43 to 3.16
|
3.69 titers (1/dilution)
Interval 2.84 to 4.81
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers of Meningococcal Serogroups A, C, Y, and W Antibodies Following Injection With MenACYW Conjugate Vaccine Administered Alone or Concomitantly With Other Pediatric Vaccines: Groups 1, 2, 4, 5, 7, 8, 10, and 11
Serogroup C: Day 30
|
876 titers (1/dilution)
Interval 725.0 to 1057.0
|
600 titers (1/dilution)
Interval 456.0 to 790.0
|
749 titers (1/dilution)
Interval 633.0 to 886.0
|
666 titers (1/dilution)
Interval 538.0 to 825.0
|
205 titers (1/dilution)
Interval 156.0 to 269.0
|
309 titers (1/dilution)
Interval 218.0 to 437.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers of Meningococcal Serogroups A, C, Y, and W Antibodies Following Injection With MenACYW Conjugate Vaccine Administered Alone or Concomitantly With Other Pediatric Vaccines: Groups 1, 2, 4, 5, 7, 8, 10, and 11
Serogroup Y: Day 0
|
3.14 titers (1/dilution)
Interval 2.78 to 3.54
|
3.12 titers (1/dilution)
Interval 2.58 to 3.78
|
2.63 titers (1/dilution)
Interval 2.37 to 2.92
|
2.94 titers (1/dilution)
Interval 2.45 to 3.53
|
2.90 titers (1/dilution)
Interval 2.56 to 3.28
|
3.49 titers (1/dilution)
Interval 2.68 to 4.53
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers of Meningococcal Serogroups A, C, Y, and W Antibodies Following Injection With MenACYW Conjugate Vaccine Administered Alone or Concomitantly With Other Pediatric Vaccines: Groups 1, 2, 4, 5, 7, 8, 10, and 11
Serogroup Y: Day 30
|
88.9 titers (1/dilution)
Interval 75.1 to 105.0
|
60.0 titers (1/dilution)
Interval 47.3 to 76.3
|
79.7 titers (1/dilution)
Interval 65.7 to 96.6
|
90.9 titers (1/dilution)
Interval 66.8 to 124.0
|
139 titers (1/dilution)
Interval 111.0 to 173.0
|
172 titers (1/dilution)
Interval 130.0 to 229.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers of Meningococcal Serogroups A, C, Y, and W Antibodies Following Injection With MenACYW Conjugate Vaccine Administered Alone or Concomitantly With Other Pediatric Vaccines: Groups 1, 2, 4, 5, 7, 8, 10, and 11
Serogroup W: Day 0
|
2.15 titers (1/dilution)
Interval 2.0 to 2.3
|
2.31 titers (1/dilution)
Interval 2.02 to 2.64
|
2.41 titers (1/dilution)
Interval 2.22 to 2.62
|
2.16 titers (1/dilution)
Interval 2.04 to 2.3
|
2.93 titers (1/dilution)
Interval 2.54 to 3.38
|
3.62 titers (1/dilution)
Interval 2.73 to 4.79
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers of Meningococcal Serogroups A, C, Y, and W Antibodies Following Injection With MenACYW Conjugate Vaccine Administered Alone or Concomitantly With Other Pediatric Vaccines: Groups 1, 2, 4, 5, 7, 8, 10, and 11
Serogroup W: Day 30
|
46.8 titers (1/dilution)
Interval 39.1 to 56.0
|
35.5 titers (1/dilution)
Interval 27.6 to 45.7
|
40.0 titers (1/dilution)
Interval 32.5 to 49.3
|
50.9 titers (1/dilution)
Interval 37.2 to 69.8
|
57.4 titers (1/dilution)
Interval 47.9 to 68.6
|
57.0 titers (1/dilution)
Interval 44.3 to 73.5
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 0 and Day 30 post-vaccinationPopulation: Analysis was performed on PPAS. Data for this outcome measure were not planned to be collected and analyzed for Groups 3, 6, 9, and 12.
Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by hSBA assay. Data for this outcome measure was planned to be reported for the combined population of Groups 1 and 10, Groups 2 and 11.
Outcome measures
| Measure |
Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine
n=177 Participants
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) from South Korea and Thailand received single dose of MenACYW Conjugate vaccine, MMR vaccine, and varicella vaccine on Day 0.
|
Groups 2 and 11: MenACYW Conjugate Vaccine
n=87 Participants
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) from South Korea and Thailand received single dose of MenACYW Conjugate vaccine on Day 0.
|
Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine
n=155 Participants
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine and DTaP-IPV-HB-Hib vaccine on Day 0.
|
Mexico (Group 5): MenACYW Conjugate Vaccine
n=79 Participants
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
|
Russian Federation (Group 7): MenACYW Conjugate +PCV13 Vaccine
n=196 Participants
Healthy, meningococcal-vaccine naïve toddlers (aged 15 to 23 months) received single dose of MenACYW Conjugate vaccine and PCV13 vaccine on Day 0.
|
Russian Federation (Group 8): MenACYW Conjugate Vaccine
n=96 Participants
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 14 months or 16 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
|
Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine and DTaP-IPV-HB-Hib vaccine on Day 0.
|
Mexico (Group 5): MenACYW Conjugate Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
|
Mexico (Group 6): DTaP-IPV-HB-Hib Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of DTaP-IPV-HB-Hib Vaccine on Day 0.
|
Russian Federation (Group7): MenACYW Conjugate + PCV13 Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 15 to 23 months) received single dose of MenACYW Conjugate vaccine and PCV13 vaccine on Day 0.
|
Russian Federation (Group 8): MenACYW Conjugate Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 14 months or 16 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
|
Russian Federation (Group 9): PCV13 Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 15 to 23 months) received single dose of PCV13 vaccine on Day 0.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W Following Injection With MenACYW Conjugate Vaccine Administered Alone or With Other Pediatric Vaccines: Groups 1, 2, 4, 5, 7, 8, 10, and 11
Serogroup A: Day 0 (>=1:4)
|
75.1 percentage of participants
Interval 68.1 to 81.3
|
82.8 percentage of participants
Interval 73.2 to 90.0
|
82.6 percentage of participants
Interval 75.7 to 88.2
|
82.3 percentage of participants
Interval 72.1 to 90.0
|
82.1 percentage of participants
Interval 76.1 to 87.2
|
85.4 percentage of participants
Interval 76.7 to 91.8
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W Following Injection With MenACYW Conjugate Vaccine Administered Alone or With Other Pediatric Vaccines: Groups 1, 2, 4, 5, 7, 8, 10, and 11
Serogroup A: Day 0 (>=1:8)
|
37.9 percentage of participants
Interval 30.7 to 45.4
|
44.8 percentage of participants
Interval 34.1 to 55.9
|
45.8 percentage of participants
Interval 37.8 to 54.0
|
46.8 percentage of participants
Interval 35.5 to 58.4
|
49.0 percentage of participants
Interval 41.8 to 56.2
|
54.2 percentage of participants
Interval 43.7 to 64.4
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W Following Injection With MenACYW Conjugate Vaccine Administered Alone or With Other Pediatric Vaccines: Groups 1, 2, 4, 5, 7, 8, 10, and 11
Serogroup A: Day 30 (>=1:4)
|
98.9 percentage of participants
Interval 96.0 to 99.9
|
95.4 percentage of participants
Interval 88.6 to 98.7
|
98.1 percentage of participants
Interval 94.4 to 99.6
|
97.5 percentage of participants
Interval 91.2 to 99.7
|
94.9 percentage of participants
Interval 90.8 to 97.5
|
97.9 percentage of participants
Interval 92.7 to 99.7
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W Following Injection With MenACYW Conjugate Vaccine Administered Alone or With Other Pediatric Vaccines: Groups 1, 2, 4, 5, 7, 8, 10, and 11
Serogroup A: Day 30 (>=1:8)
|
97.7 percentage of participants
Interval 94.3 to 99.4
|
92.0 percentage of participants
Interval 84.1 to 96.7
|
92.9 percentage of participants
Interval 87.7 to 96.4
|
89.9 percentage of participants
Interval 81.0 to 95.5
|
83.7 percentage of participants
Interval 77.7 to 88.6
|
90.6 percentage of participants
Interval 82.9 to 95.6
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W Following Injection With MenACYW Conjugate Vaccine Administered Alone or With Other Pediatric Vaccines: Groups 1, 2, 4, 5, 7, 8, 10, and 11
Serogroup C: Day 0 (>=1:4)
|
9.6 percentage of participants
Interval 5.7 to 14.9
|
16.1 percentage of participants
Interval 9.1 to 25.5
|
12.3 percentage of participants
Interval 7.5 to 18.5
|
7.6 percentage of participants
Interval 2.8 to 15.8
|
19.9 percentage of participants
Interval 14.5 to 26.2
|
36.5 percentage of participants
Interval 26.9 to 46.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W Following Injection With MenACYW Conjugate Vaccine Administered Alone or With Other Pediatric Vaccines: Groups 1, 2, 4, 5, 7, 8, 10, and 11
Serogroup C: Day 0 (>=1:8)
|
4.0 percentage of participants
Interval 1.6 to 8.0
|
6.9 percentage of participants
Interval 2.6 to 14.4
|
1.9 percentage of participants
Interval 0.4 to 5.6
|
1.3 percentage of participants
Interval 0.0 to 6.9
|
8.7 percentage of participants
Interval 5.1 to 13.5
|
17.7 percentage of participants
Interval 10.7 to 26.8
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W Following Injection With MenACYW Conjugate Vaccine Administered Alone or With Other Pediatric Vaccines: Groups 1, 2, 4, 5, 7, 8, 10, and 11
Serogroup C: Day 30 (>=1:4)
|
100.0 percentage of participants
Interval 97.9 to 100.0
|
100.0 percentage of participants
Interval 95.8 to 100.0
|
100.0 percentage of participants
Interval 97.6 to 100.0
|
100.0 percentage of participants
Interval 95.4 to 100.0
|
98.5 percentage of participants
Interval 95.6 to 99.7
|
99.0 percentage of participants
Interval 94.3 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W Following Injection With MenACYW Conjugate Vaccine Administered Alone or With Other Pediatric Vaccines: Groups 1, 2, 4, 5, 7, 8, 10, and 11
Serogroup C: Day 30 (>=1:8)
|
100.0 percentage of participants
Interval 97.9 to 100.0
|
100.0 percentage of participants
Interval 95.8 to 100.0
|
100.0 percentage of participants
Interval 97.6 to 100.0
|
100.0 percentage of participants
Interval 95.4 to 100.0
|
93.9 percentage of participants
Interval 89.5 to 96.8
|
99.0 percentage of participants
Interval 94.3 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W Following Injection With MenACYW Conjugate Vaccine Administered Alone or With Other Pediatric Vaccines: Groups 1, 2, 4, 5, 7, 8, 10, and 11
Serogroup Y: Day 0 (>=1:4)
|
32.2 percentage of participants
Interval 25.4 to 39.6
|
28.7 percentage of participants
Interval 19.5 to 39.4
|
19.4 percentage of participants
Interval 13.5 to 26.5
|
25.3 percentage of participants
Interval 16.2 to 36.4
|
21.9 percentage of participants
Interval 16.4 to 28.4
|
32.3 percentage of participants
Interval 23.1 to 42.6
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W Following Injection With MenACYW Conjugate Vaccine Administered Alone or With Other Pediatric Vaccines: Groups 1, 2, 4, 5, 7, 8, 10, and 11
Serogroup Y: Day 0 (>=1:8)
|
18.6 percentage of participants
Interval 13.2 to 25.2
|
17.2 percentage of participants
Interval 10.0 to 26.8
|
11.0 percentage of participants
Interval 6.5 to 17.0
|
12.7 percentage of participants
Interval 6.2 to 22.0
|
14.3 percentage of participants
Interval 9.7 to 20.0
|
15.6 percentage of participants
Interval 9.0 to 24.5
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W Following Injection With MenACYW Conjugate Vaccine Administered Alone or With Other Pediatric Vaccines: Groups 1, 2, 4, 5, 7, 8, 10, and 11
Serogroup Y: Day 30 (>=1:4)
|
99.4 percentage of participants
Interval 96.9 to 100.0
|
96.6 percentage of participants
Interval 90.3 to 99.3
|
98.7 percentage of participants
Interval 95.4 to 99.8
|
100.0 percentage of participants
Interval 95.4 to 100.0
|
98.5 percentage of participants
Interval 95.6 to 99.7
|
99.0 percentage of participants
Interval 94.3 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W Following Injection With MenACYW Conjugate Vaccine Administered Alone or With Other Pediatric Vaccines: Groups 1, 2, 4, 5, 7, 8, 10, and 11
Serogroup Y: Day 30 (>=1:8)
|
99.4 percentage of participants
Interval 96.9 to 100.0
|
95.4 percentage of participants
Interval 88.6 to 98.7
|
98.7 percentage of participants
Interval 95.4 to 99.8
|
98.7 percentage of participants
Interval 93.1 to 100.0
|
97.4 percentage of participants
Interval 94.1 to 99.2
|
97.9 percentage of participants
Interval 92.7 to 99.7
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W Following Injection With MenACYW Conjugate Vaccine Administered Alone or With Other Pediatric Vaccines: Groups 1, 2, 4, 5, 7, 8, 10, and 11
Serogroup W: Day 0 (>=1:4)
|
5.1 percentage of participants
Interval 2.4 to 9.4
|
11.5 percentage of participants
Interval 5.7 to 20.1
|
14.8 percentage of participants
Interval 9.6 to 21.4
|
8.9 percentage of participants
Interval 3.6 to 17.4
|
16.8 percentage of participants
Interval 11.9 to 22.8
|
26.0 percentage of participants
Interval 17.6 to 36.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W Following Injection With MenACYW Conjugate Vaccine Administered Alone or With Other Pediatric Vaccines: Groups 1, 2, 4, 5, 7, 8, 10, and 11
Serogroup W: Day 0 (>=1:8)
|
1.1 percentage of participants
Interval 0.1 to 4.0
|
2.3 percentage of participants
Interval 0.3 to 8.1
|
7.7 percentage of participants
Interval 4.1 to 13.1
|
2.5 percentage of participants
Interval 0.3 to 8.8
|
12.8 percentage of participants
Interval 8.4 to 18.3
|
20.8 percentage of participants
Interval 13.2 to 30.3
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W Following Injection With MenACYW Conjugate Vaccine Administered Alone or With Other Pediatric Vaccines: Groups 1, 2, 4, 5, 7, 8, 10, and 11
Serogroup W: Day 30 (>=1:4)
|
98.9 percentage of participants
Interval 96.0 to 99.9
|
96.6 percentage of participants
Interval 90.3 to 99.3
|
97.4 percentage of participants
Interval 93.5 to 99.3
|
96.2 percentage of participants
Interval 89.3 to 99.2
|
95.9 percentage of participants
Interval 92.1 to 98.2
|
96.9 percentage of participants
Interval 91.1 to 99.4
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W Following Injection With MenACYW Conjugate Vaccine Administered Alone or With Other Pediatric Vaccines: Groups 1, 2, 4, 5, 7, 8, 10, and 11
Serogroup W: Day 30 (>=1:8)
|
96.0 percentage of participants
Interval 92.0 to 98.4
|
92.0 percentage of participants
Interval 84.1 to 96.7
|
90.3 percentage of participants
Interval 84.5 to 94.5
|
92.4 percentage of participants
Interval 84.2 to 97.2
|
94.4 percentage of participants
Interval 90.2 to 97.2
|
95.8 percentage of participants
Interval 89.7 to 98.9
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 0 up to Day 30 post-vaccinationPopulation: Analysis was performed on PPAS. Data for this outcome measure were not planned to be collected and analyzed for Groups 3, 6, 9, and 12.
Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by hSBA assay. Data for this outcome measure was planned to be reported for the combined population of Groups 1 and 10, Groups 2 and 11.
Outcome measures
| Measure |
Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine
n=177 Participants
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) from South Korea and Thailand received single dose of MenACYW Conjugate vaccine, MMR vaccine, and varicella vaccine on Day 0.
|
Groups 2 and 11: MenACYW Conjugate Vaccine
n=87 Participants
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) from South Korea and Thailand received single dose of MenACYW Conjugate vaccine on Day 0.
|
Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine
n=155 Participants
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine and DTaP-IPV-HB-Hib vaccine on Day 0.
|
Mexico (Group 5): MenACYW Conjugate Vaccine
n=79 Participants
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
|
Russian Federation (Group 7): MenACYW Conjugate +PCV13 Vaccine
n=196 Participants
Healthy, meningococcal-vaccine naïve toddlers (aged 15 to 23 months) received single dose of MenACYW Conjugate vaccine and PCV13 vaccine on Day 0.
|
Russian Federation (Group 8): MenACYW Conjugate Vaccine
n=96 Participants
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 14 months or 16 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
|
Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine and DTaP-IPV-HB-Hib vaccine on Day 0.
|
Mexico (Group 5): MenACYW Conjugate Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
|
Mexico (Group 6): DTaP-IPV-HB-Hib Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of DTaP-IPV-HB-Hib Vaccine on Day 0.
|
Russian Federation (Group7): MenACYW Conjugate + PCV13 Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 15 to 23 months) received single dose of MenACYW Conjugate vaccine and PCV13 vaccine on Day 0.
|
Russian Federation (Group 8): MenACYW Conjugate Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 14 months or 16 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
|
Russian Federation (Group 9): PCV13 Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 15 to 23 months) received single dose of PCV13 vaccine on Day 0.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With >=4-Fold Rise in Antibody Titers Against Meningococcal Serogroups A, C, Y, and W Following Injection With MenACYW Conjugate Vaccine Administered Alone or With Other Pediatric Vaccines: Groups 1, 2, 4, 5, 7, 8, 10, and 11
Serogroup A
|
82.5 percentage of participants
Interval 76.1 to 87.8
|
64.4 percentage of participants
Interval 53.4 to 74.4
|
69.0 percentage of participants
Interval 61.1 to 76.2
|
70.9 percentage of participants
Interval 59.6 to 80.6
|
58.2 percentage of participants
Interval 50.9 to 65.2
|
72.9 percentage of participants
Interval 62.9 to 81.5
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With >=4-Fold Rise in Antibody Titers Against Meningococcal Serogroups A, C, Y, and W Following Injection With MenACYW Conjugate Vaccine Administered Alone or With Other Pediatric Vaccines: Groups 1, 2, 4, 5, 7, 8, 10, and 11
Serogroup C
|
98.3 percentage of participants
Interval 95.1 to 99.6
|
98.9 percentage of participants
Interval 93.8 to 100.0
|
100.0 percentage of participants
Interval 97.6 to 100.0
|
98.7 percentage of participants
Interval 93.1 to 100.0
|
92.3 percentage of participants
Interval 87.7 to 95.7
|
91.7 percentage of participants
Interval 84.2 to 96.3
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With >=4-Fold Rise in Antibody Titers Against Meningococcal Serogroups A, C, Y, and W Following Injection With MenACYW Conjugate Vaccine Administered Alone or With Other Pediatric Vaccines: Groups 1, 2, 4, 5, 7, 8, 10, and 11
Serogroup Y
|
95.5 percentage of participants
Interval 91.3 to 98.0
|
89.7 percentage of participants
Interval 81.3 to 95.2
|
96.8 percentage of participants
Interval 92.6 to 98.9
|
94.9 percentage of participants
Interval 87.5 to 98.6
|
94.4 percentage of participants
Interval 90.2 to 97.2
|
93.8 percentage of participants
Interval 86.9 to 97.7
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With >=4-Fold Rise in Antibody Titers Against Meningococcal Serogroups A, C, Y, and W Following Injection With MenACYW Conjugate Vaccine Administered Alone or With Other Pediatric Vaccines: Groups 1, 2, 4, 5, 7, 8, 10, and 11
Serogroup W
|
94.9 percentage of participants
Interval 90.6 to 97.6
|
89.7 percentage of participants
Interval 81.3 to 95.2
|
86.5 percentage of participants
Interval 80.0 to 91.4
|
92.4 percentage of participants
Interval 84.2 to 97.2
|
88.8 percentage of participants
Interval 83.5 to 92.8
|
90.6 percentage of participants
Interval 82.9 to 95.6
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 30 post-vaccinationPopulation: Analysis was performed on PPAS. Data for this outcome measure were not planned to be collected and analyzed for Groups 3, 6, 9 and 12.
The hSBA vaccine seroresponse for serogroups A, C, Y, and W was defined as post-vaccination hSBA titers \>=1:16 for participants with pre-vaccination titers \<1:8 or at least a 4-fold increase in post-vaccination hSBA titers from pre- to post-vaccination, for participants with pre-vaccination titers \>=1:8. Data for this outcome measure was planned to be reported for the combined population of Groups 1 and 10, Groups 2 and 11.
Outcome measures
| Measure |
Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine
n=177 Participants
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) from South Korea and Thailand received single dose of MenACYW Conjugate vaccine, MMR vaccine, and varicella vaccine on Day 0.
|
Groups 2 and 11: MenACYW Conjugate Vaccine
n=87 Participants
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) from South Korea and Thailand received single dose of MenACYW Conjugate vaccine on Day 0.
|
Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine
n=155 Participants
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine and DTaP-IPV-HB-Hib vaccine on Day 0.
|
Mexico (Group 5): MenACYW Conjugate Vaccine
n=79 Participants
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
|
Russian Federation (Group 7): MenACYW Conjugate +PCV13 Vaccine
n=196 Participants
Healthy, meningococcal-vaccine naïve toddlers (aged 15 to 23 months) received single dose of MenACYW Conjugate vaccine and PCV13 vaccine on Day 0.
|
Russian Federation (Group 8): MenACYW Conjugate Vaccine
n=96 Participants
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 14 months or 16 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
|
Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine and DTaP-IPV-HB-Hib vaccine on Day 0.
|
Mexico (Group 5): MenACYW Conjugate Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
|
Mexico (Group 6): DTaP-IPV-HB-Hib Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of DTaP-IPV-HB-Hib Vaccine on Day 0.
|
Russian Federation (Group7): MenACYW Conjugate + PCV13 Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 15 to 23 months) received single dose of MenACYW Conjugate vaccine and PCV13 vaccine on Day 0.
|
Russian Federation (Group 8): MenACYW Conjugate Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 14 months or 16 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
|
Russian Federation (Group 9): PCV13 Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 15 to 23 months) received single dose of PCV13 vaccine on Day 0.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving hSBA Vaccine Seroresponse for Meningococcal Serogroups A, C, Y, and W Following Injection With MenACYW Conjugate Vaccine Administered Alone or Concomitantly With Pediatric Vaccines: Groups 1, 2, 4, 5, 7, 8, 10, and 11
Serogroup Y
|
93.2 percentage of participants
Interval 88.5 to 96.4
|
88.5 percentage of participants
Interval 79.9 to 94.3
|
92.3 percentage of participants
Interval 86.9 to 95.9
|
87.3 percentage of participants
Interval 78.0 to 93.8
|
92.9 percentage of participants
Interval 88.3 to 96.0
|
92.7 percentage of participants
Interval 85.6 to 97.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving hSBA Vaccine Seroresponse for Meningococcal Serogroups A, C, Y, and W Following Injection With MenACYW Conjugate Vaccine Administered Alone or Concomitantly With Pediatric Vaccines: Groups 1, 2, 4, 5, 7, 8, 10, and 11
Serogroup A
|
78.5 percentage of participants
Interval 71.7 to 84.3
|
63.2 percentage of participants
Interval 52.2 to 73.3
|
67.1 percentage of participants
Interval 59.1 to 74.4
|
69.6 percentage of participants
Interval 58.2 to 79.5
|
56.1 percentage of participants
Interval 48.9 to 63.2
|
71.9 percentage of participants
Interval 61.8 to 80.6
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving hSBA Vaccine Seroresponse for Meningococcal Serogroups A, C, Y, and W Following Injection With MenACYW Conjugate Vaccine Administered Alone or Concomitantly With Pediatric Vaccines: Groups 1, 2, 4, 5, 7, 8, 10, and 11
Serogroup C
|
97.7 percentage of participants
Interval 94.3 to 99.4
|
98.9 percentage of participants
Interval 93.8 to 100.0
|
100.0 percentage of participants
Interval 97.6 to 100.0
|
98.7 percentage of participants
Interval 93.1 to 100.0
|
90.8 percentage of participants
Interval 85.9 to 94.5
|
91.7 percentage of participants
Interval 84.2 to 96.3
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving hSBA Vaccine Seroresponse for Meningococcal Serogroups A, C, Y, and W Following Injection With MenACYW Conjugate Vaccine Administered Alone or Concomitantly With Pediatric Vaccines: Groups 1, 2, 4, 5, 7, 8, 10, and 11
Serogroup W
|
86.4 percentage of participants
Interval 80.5 to 91.1
|
83.9 percentage of participants
Interval 74.5 to 90.9
|
82.6 percentage of participants
Interval 75.7 to 88.2
|
82.3 percentage of participants
Interval 72.1 to 90.0
|
82.1 percentage of participants
Interval 76.1 to 87.2
|
90.6 percentage of participants
Interval 82.9 to 95.6
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 0 and Day 30 post-vaccinationPopulation: Analysis was performed on PPAS. Here, 'Number analyzed' = participants with available data for each specified category. Data for this outcome measure were not planned to be collected and analyzed for Groups 2, 4, 5, 6, 7, 8, 9, and 11.
Antibodies titers of Measles and Rubella were measured by enzyme immunoassay (EIA). Antibodies titers for mumps and varicella were measured by enzyme-linked immunosorbent assay (ELISA). Data for this outcome measure was planned to be reported for the combined population of Groups 1 and 10, Groups 3 and 12.
Outcome measures
| Measure |
Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine
n=177 Participants
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) from South Korea and Thailand received single dose of MenACYW Conjugate vaccine, MMR vaccine, and varicella vaccine on Day 0.
|
Groups 2 and 11: MenACYW Conjugate Vaccine
n=92 Participants
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) from South Korea and Thailand received single dose of MenACYW Conjugate vaccine on Day 0.
|
Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine and DTaP-IPV-HB-Hib vaccine on Day 0.
|
Mexico (Group 5): MenACYW Conjugate Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
|
Russian Federation (Group 7): MenACYW Conjugate +PCV13 Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 15 to 23 months) received single dose of MenACYW Conjugate vaccine and PCV13 vaccine on Day 0.
|
Russian Federation (Group 8): MenACYW Conjugate Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 14 months or 16 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
|
Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine and DTaP-IPV-HB-Hib vaccine on Day 0.
|
Mexico (Group 5): MenACYW Conjugate Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
|
Mexico (Group 6): DTaP-IPV-HB-Hib Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of DTaP-IPV-HB-Hib Vaccine on Day 0.
|
Russian Federation (Group7): MenACYW Conjugate + PCV13 Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 15 to 23 months) received single dose of MenACYW Conjugate vaccine and PCV13 vaccine on Day 0.
|
Russian Federation (Group 8): MenACYW Conjugate Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 14 months or 16 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
|
Russian Federation (Group 9): PCV13 Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 15 to 23 months) received single dose of PCV13 vaccine on Day 0.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Titers of MMR-Varicella Antibodies Following Injection With MMR-Varicella Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 1, 3, 10, and 12
Measles: Day 0
|
40.0 titers (1/dilution)
Interval 37.2 to 43.1
|
45.0 titers (1/dilution)
Interval 40.1 to 50.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers of MMR-Varicella Antibodies Following Injection With MMR-Varicella Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 1, 3, 10, and 12
Measles: Day 30
|
2156 titers (1/dilution)
Interval 1893.0 to 2455.0
|
2840 titers (1/dilution)
Interval 2389.0 to 3378.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers of MMR-Varicella Antibodies Following Injection With MMR-Varicella Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 1, 3, 10, and 12
Mumps: Day 0
|
5.51 titers (1/dilution)
Interval 5.2 to 5.84
|
5.43 titers (1/dilution)
Interval 5.05 to 5.83
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers of MMR-Varicella Antibodies Following Injection With MMR-Varicella Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 1, 3, 10, and 12
Mumps: Day 30
|
85.9 titers (1/dilution)
Interval 74.7 to 98.7
|
97.6 titers (1/dilution)
Interval 83.1 to 115.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers of MMR-Varicella Antibodies Following Injection With MMR-Varicella Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 1, 3, 10, and 12
Rubella: Day 0
|
5.94 titers (1/dilution)
Interval 5.32 to 6.63
|
7.12 titers (1/dilution)
Interval 6.07 to 8.34
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers of MMR-Varicella Antibodies Following Injection With MMR-Varicella Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 1, 3, 10, and 12
Rubella: Day 30
|
87.6 titers (1/dilution)
Interval 79.4 to 96.7
|
104 titers (1/dilution)
Interval 91.2 to 118.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers of MMR-Varicella Antibodies Following Injection With MMR-Varicella Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 1, 3, 10, and 12
Varicella: Day 0
|
0.556 titers (1/dilution)
Interval 0.484 to 0.638
|
0.665 titers (1/dilution)
Interval 0.508 to 0.869
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers of MMR-Varicella Antibodies Following Injection With MMR-Varicella Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 1, 3, 10, and 12
Varicella: Day 30
|
13.4 titers (1/dilution)
Interval 11.6 to 15.4
|
17.4 titers (1/dilution)
Interval 15.2 to 19.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 0 and Day 30 post-vaccinationPopulation: Analysis was performed on PPAS. Here, 'Number analyzed' = participants with available data for each specified category. Data for this outcome measure were not planned to be collected and analyzed for Groups 2, 4, 5, 6, 7, 8, 9, and 11.
Immune response for MMR-Varicella vaccine was defined as: anti-measles Antibody (Ab) concentrations \>=255 milli-international unit per milliliter (mIU/mL), anti-mumps Ab concentrations: \>=10 Ab units/mL, anti-rubella Ab concentrations \>=10 international unit per milliliter (IU/mL),anti-varicella Ab concentrations \>=5 glycoprotein enzyme-linked immunosorbent assay (gpELISA) Ab units/mL. Data for this outcome measure was planned to be reported for the combined population of Groups 1 and 10, Groups 3 and 12.
Outcome measures
| Measure |
Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine
n=177 Participants
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) from South Korea and Thailand received single dose of MenACYW Conjugate vaccine, MMR vaccine, and varicella vaccine on Day 0.
|
Groups 2 and 11: MenACYW Conjugate Vaccine
n=92 Participants
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) from South Korea and Thailand received single dose of MenACYW Conjugate vaccine on Day 0.
|
Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine and DTaP-IPV-HB-Hib vaccine on Day 0.
|
Mexico (Group 5): MenACYW Conjugate Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
|
Russian Federation (Group 7): MenACYW Conjugate +PCV13 Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 15 to 23 months) received single dose of MenACYW Conjugate vaccine and PCV13 vaccine on Day 0.
|
Russian Federation (Group 8): MenACYW Conjugate Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 14 months or 16 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
|
Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine and DTaP-IPV-HB-Hib vaccine on Day 0.
|
Mexico (Group 5): MenACYW Conjugate Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
|
Mexico (Group 6): DTaP-IPV-HB-Hib Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of DTaP-IPV-HB-Hib Vaccine on Day 0.
|
Russian Federation (Group7): MenACYW Conjugate + PCV13 Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 15 to 23 months) received single dose of MenACYW Conjugate vaccine and PCV13 vaccine on Day 0.
|
Russian Federation (Group 8): MenACYW Conjugate Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 14 months or 16 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
|
Russian Federation (Group 9): PCV13 Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 15 to 23 months) received single dose of PCV13 vaccine on Day 0.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Immune Response Following Injection With MMR-Varicella Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 1, 3, 10, and 12
Measles: Day 0
|
0.6 percentage of participants
Interval 0.0 to 3.1
|
0.0 percentage of participants
Interval 0.0 to 3.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Immune Response Following Injection With MMR-Varicella Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 1, 3, 10, and 12
Measles: Day 30
|
96.6 percentage of participants
Interval 92.8 to 98.7
|
97.8 percentage of participants
Interval 92.4 to 99.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Immune Response Following Injection With MMR-Varicella Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 1, 3, 10, and 12
Mumps: Day 0
|
7.4 percentage of participants
Interval 4.0 to 12.3
|
6.5 percentage of participants
Interval 2.4 to 13.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Immune Response Following Injection With MMR-Varicella Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 1, 3, 10, and 12
Mumps: Day 30
|
97.7 percentage of participants
Interval 94.3 to 99.4
|
100.0 percentage of participants
Interval 96.1 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Immune Response Following Injection With MMR-Varicella Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 1, 3, 10, and 12
Rubella: Day 0
|
27.3 percentage of participants
Interval 20.8 to 34.5
|
31.5 percentage of participants
Interval 22.2 to 42.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Immune Response Following Injection With MMR-Varicella Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 1, 3, 10, and 12
Rubella: Day 30
|
100.0 percentage of participants
Interval 97.9 to 100.0
|
100.0 percentage of participants
Interval 96.1 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Immune Response Following Injection With MMR-Varicella Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 1, 3, 10, and 12
Varicella: Day 0
|
4.0 percentage of participants
Interval 1.6 to 8.0
|
7.6 percentage of participants
Interval 3.1 to 15.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Immune Response Following Injection With MMR-Varicella Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 1, 3, 10, and 12
Varicella: Day 30
|
93.2 percentage of participants
Interval 88.5 to 96.4
|
98.9 percentage of participants
Interval 94.1 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 0 and Day 30 post-vaccinationPopulation: Analysis was performed on PPAS. Data for this outcome measure were not planned to be collected and analyzed for Groups 1, 2, 3, 5, 7, 8, 9, 10, 11, and 12.
Antibodies titers of PT and FHA were measured by electrochemiluminescent (ECL) assay.
Outcome measures
| Measure |
Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine
n=155 Participants
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) from South Korea and Thailand received single dose of MenACYW Conjugate vaccine, MMR vaccine, and varicella vaccine on Day 0.
|
Groups 2 and 11: MenACYW Conjugate Vaccine
n=68 Participants
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) from South Korea and Thailand received single dose of MenACYW Conjugate vaccine on Day 0.
|
Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine and DTaP-IPV-HB-Hib vaccine on Day 0.
|
Mexico (Group 5): MenACYW Conjugate Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
|
Russian Federation (Group 7): MenACYW Conjugate +PCV13 Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 15 to 23 months) received single dose of MenACYW Conjugate vaccine and PCV13 vaccine on Day 0.
|
Russian Federation (Group 8): MenACYW Conjugate Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 14 months or 16 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
|
Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine and DTaP-IPV-HB-Hib vaccine on Day 0.
|
Mexico (Group 5): MenACYW Conjugate Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
|
Mexico (Group 6): DTaP-IPV-HB-Hib Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of DTaP-IPV-HB-Hib Vaccine on Day 0.
|
Russian Federation (Group7): MenACYW Conjugate + PCV13 Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 15 to 23 months) received single dose of MenACYW Conjugate vaccine and PCV13 vaccine on Day 0.
|
Russian Federation (Group 8): MenACYW Conjugate Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 14 months or 16 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
|
Russian Federation (Group 9): PCV13 Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 15 to 23 months) received single dose of PCV13 vaccine on Day 0.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Titers of Pertussis Toxoid (PT) and Filamentous Hemagglutinin (FHA) Antibodies Following Injection With DTaP-IPV-HB-Hib Vaccine Administrated Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 4 and 6
PT: Day 0
|
17.9 titers (1/dilution)
Interval 15.1 to 21.3
|
20.4 titers (1/dilution)
Interval 15.3 to 27.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers of Pertussis Toxoid (PT) and Filamentous Hemagglutinin (FHA) Antibodies Following Injection With DTaP-IPV-HB-Hib Vaccine Administrated Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 4 and 6
PT: Day 30
|
144 titers (1/dilution)
Interval 130.0 to 159.0
|
169 titers (1/dilution)
Interval 144.0 to 198.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers of Pertussis Toxoid (PT) and Filamentous Hemagglutinin (FHA) Antibodies Following Injection With DTaP-IPV-HB-Hib Vaccine Administrated Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 4 and 6
FHA: Day 0
|
45.5 titers (1/dilution)
Interval 37.0 to 55.9
|
57.4 titers (1/dilution)
Interval 41.4 to 79.5
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
|
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Geometric Mean Titers of Pertussis Toxoid (PT) and Filamentous Hemagglutinin (FHA) Antibodies Following Injection With DTaP-IPV-HB-Hib Vaccine Administrated Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 4 and 6
FHA: Day 30
|
299 titers (1/dilution)
Interval 265.0 to 337.0
|
391 titers (1/dilution)
Interval 319.0 to 480.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 0 (for tetanus only) and Day 30 post-vaccinationPopulation: Analysis was performed on PPAS. Here, 'Number analyzed' = participants with available data for each specified category. Data for this outcome measure were not planned to be collected and analyzed for Groups 1, 2, 3, 5, 7, 8, 9, 10, 11, and 12.
Antibodies titers of Diphtheria, Tetanus and Pertussis were measured by ECL assay. Antibodies titers of poliovirus types 1, 2, and 3 were measured by neutralization assay. Antibodies titers of Hepatitis B were measured by an immunodiagnostic system using chemiluminescence detection. Antibodies titers of Polyribosyl-ribitol phosphate (PRP) were measured by Farr-type radioimmunoassay (RIA).
Outcome measures
| Measure |
Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine
n=155 Participants
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) from South Korea and Thailand received single dose of MenACYW Conjugate vaccine, MMR vaccine, and varicella vaccine on Day 0.
|
Groups 2 and 11: MenACYW Conjugate Vaccine
n=68 Participants
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) from South Korea and Thailand received single dose of MenACYW Conjugate vaccine on Day 0.
|
Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine and DTaP-IPV-HB-Hib vaccine on Day 0.
|
Mexico (Group 5): MenACYW Conjugate Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
|
Russian Federation (Group 7): MenACYW Conjugate +PCV13 Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 15 to 23 months) received single dose of MenACYW Conjugate vaccine and PCV13 vaccine on Day 0.
|
Russian Federation (Group 8): MenACYW Conjugate Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 14 months or 16 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
|
Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine and DTaP-IPV-HB-Hib vaccine on Day 0.
|
Mexico (Group 5): MenACYW Conjugate Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
|
Mexico (Group 6): DTaP-IPV-HB-Hib Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of DTaP-IPV-HB-Hib Vaccine on Day 0.
|
Russian Federation (Group7): MenACYW Conjugate + PCV13 Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 15 to 23 months) received single dose of MenACYW Conjugate vaccine and PCV13 vaccine on Day 0.
|
Russian Federation (Group 8): MenACYW Conjugate Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 14 months or 16 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
|
Russian Federation (Group 9): PCV13 Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 15 to 23 months) received single dose of PCV13 vaccine on Day 0.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Titers of DTaP-IPV-HB-Hib Antibodies Following Injection With DTaP-IPV-HB-Hib Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 4 and 6
Diphtheria: Day 30
|
5.52 titers (1/dilution)
Interval 4.94 to 6.17
|
6.34 titers (1/dilution)
Interval 5.51 to 7.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers of DTaP-IPV-HB-Hib Antibodies Following Injection With DTaP-IPV-HB-Hib Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 4 and 6
Tetanus: Day 0
|
0.238 titers (1/dilution)
Interval 0.196 to 0.289
|
0.234 titers (1/dilution)
Interval 0.177 to 0.309
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers of DTaP-IPV-HB-Hib Antibodies Following Injection With DTaP-IPV-HB-Hib Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 4 and 6
Tetanus: Day 30
|
7.06 titers (1/dilution)
Interval 6.01 to 8.29
|
7.11 titers (1/dilution)
Interval 5.79 to 8.74
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers of DTaP-IPV-HB-Hib Antibodies Following Injection With DTaP-IPV-HB-Hib Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 4 and 6
Polio 1: Day 30
|
4560 titers (1/dilution)
Interval 3870.0 to 5373.0
|
4034 titers (1/dilution)
Interval 3052.0 to 5332.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers of DTaP-IPV-HB-Hib Antibodies Following Injection With DTaP-IPV-HB-Hib Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 4 and 6
Polio 2: Day 30
|
7244 titers (1/dilution)
Interval 6208.0 to 8453.0
|
5618 titers (1/dilution)
Interval 4578.0 to 6895.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers of DTaP-IPV-HB-Hib Antibodies Following Injection With DTaP-IPV-HB-Hib Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 4 and 6
Polio 3: Day 30
|
5977 titers (1/dilution)
Interval 4958.0 to 7205.0
|
5100 titers (1/dilution)
Interval 3840.0 to 6772.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers of DTaP-IPV-HB-Hib Antibodies Following Injection With DTaP-IPV-HB-Hib Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 4 and 6
Hepatitis B: Day 30
|
5171 titers (1/dilution)
Interval 4104.0 to 6515.0
|
7308 titers (1/dilution)
Interval 5135.0 to 10401.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers of DTaP-IPV-HB-Hib Antibodies Following Injection With DTaP-IPV-HB-Hib Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 4 and 6
PRP: Day 30
|
46.6 titers (1/dilution)
Interval 39.6 to 54.9
|
56.2 titers (1/dilution)
Interval 41.5 to 76.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 0 (tetanus only) and Day 30 post-vaccinationPopulation: Analysis was performed on PPAS. Here, 'Number analyzed' = participants with available data for each specified category. Data for this outcome measure were not planned to be collected and analyzed for Groups 1, 2, 3, 5, 7, 8, 9, 10, 11 and 12.
Immune response for DTaP-IPV-HB-Hib vaccine was defined as: anti-tetanus Ab concentrations: \>= 0.01 and 0.1 IU/mL at Day 0 and \>= 0.1 and 1.0 IU/mL at Day 30, anti-diphtheria Ab concentrations: \>= 0.1 and 1.0 IU/mL, anti-PRP Ab concentrations \>= 0.15 and 1.0 microgram per milliliter (mcg/mL), anti-poliovirus types 1, 2, and 3 Ab titers \>= 1:8, anti-hepatitis B surface antigen Ab concentrations \>= 10 mIU/mL, \>= 100 mIU/mL.
Outcome measures
| Measure |
Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine
n=155 Participants
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) from South Korea and Thailand received single dose of MenACYW Conjugate vaccine, MMR vaccine, and varicella vaccine on Day 0.
|
Groups 2 and 11: MenACYW Conjugate Vaccine
n=68 Participants
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) from South Korea and Thailand received single dose of MenACYW Conjugate vaccine on Day 0.
|
Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine and DTaP-IPV-HB-Hib vaccine on Day 0.
|
Mexico (Group 5): MenACYW Conjugate Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
|
Russian Federation (Group 7): MenACYW Conjugate +PCV13 Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 15 to 23 months) received single dose of MenACYW Conjugate vaccine and PCV13 vaccine on Day 0.
|
Russian Federation (Group 8): MenACYW Conjugate Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 14 months or 16 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
|
Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine and DTaP-IPV-HB-Hib vaccine on Day 0.
|
Mexico (Group 5): MenACYW Conjugate Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
|
Mexico (Group 6): DTaP-IPV-HB-Hib Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of DTaP-IPV-HB-Hib Vaccine on Day 0.
|
Russian Federation (Group7): MenACYW Conjugate + PCV13 Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 15 to 23 months) received single dose of MenACYW Conjugate vaccine and PCV13 vaccine on Day 0.
|
Russian Federation (Group 8): MenACYW Conjugate Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 14 months or 16 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
|
Russian Federation (Group 9): PCV13 Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 15 to 23 months) received single dose of PCV13 vaccine on Day 0.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Immune Response Following Injection With DTaP-IPV-HB-Hib Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 4 and 6
Diphtheria: Day 30 (>=0.1 IU/mL)
|
100.0 percentage of participants
Interval 97.6 to 100.0
|
100.0 percentage of participants
Interval 94.7 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Immune Response Following Injection With DTaP-IPV-HB-Hib Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 4 and 6
Diphtheria: Day 30 (>=1 IU/mL)
|
98.7 percentage of participants
Interval 95.4 to 99.8
|
100.0 percentage of participants
Interval 94.7 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Immune Response Following Injection With DTaP-IPV-HB-Hib Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 4 and 6
Tetanus: Day 0 (>=0.01 IU/mL)
|
100.0 percentage of participants
Interval 97.6 to 100.0
|
100.0 percentage of participants
Interval 94.6 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Immune Response Following Injection With DTaP-IPV-HB-Hib Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 4 and 6
Tetanus: Day 0 (>=0.1 IU/mL)
|
81.3 percentage of participants
Interval 74.2 to 87.1
|
77.6 percentage of participants
Interval 65.8 to 86.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Immune Response Following Injection With DTaP-IPV-HB-Hib Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 4 and 6
Tetanus: Day 30 (>=0.1 IU/mL)
|
100.0 percentage of participants
Interval 97.6 to 100.0
|
100.0 percentage of participants
Interval 94.7 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Immune Response Following Injection With DTaP-IPV-HB-Hib Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 4 and 6
Tetanus: Day 30 (>=1 IU/mL)
|
98.1 percentage of participants
Interval 94.4 to 99.6
|
98.5 percentage of participants
Interval 92.1 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Immune Response Following Injection With DTaP-IPV-HB-Hib Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 4 and 6
Polio 1: Day 30 (>=8 [1/dilution])
|
100.0 percentage of participants
Interval 97.6 to 100.0
|
100.0 percentage of participants
Interval 94.7 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Immune Response Following Injection With DTaP-IPV-HB-Hib Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 4 and 6
Polio 2: Day 30 (>=8 [1/dilution])
|
100.0 percentage of participants
Interval 97.6 to 100.0
|
100.0 percentage of participants
Interval 94.7 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Immune Response Following Injection With DTaP-IPV-HB-Hib Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 4 and 6
Polio 3: Day 30 (>=8 [1/dilution])
|
100.0 percentage of participants
Interval 97.6 to 100.0
|
100.0 percentage of participants
Interval 94.7 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Immune Response Following Injection With DTaP-IPV-HB-Hib Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 4 and 6
Hepatitis B: Day 30 (>=10 mIU/mL)
|
100.0 percentage of participants
Interval 97.6 to 100.0
|
100.0 percentage of participants
Interval 94.7 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Immune Response Following Injection With DTaP-IPV-HB-Hib Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 4 and 6
Hepatitis B: Day 30 (>=100 mIU/mL)
|
98.7 percentage of participants
Interval 95.4 to 99.8
|
100.0 percentage of participants
Interval 94.7 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Immune Response Following Injection With DTaP-IPV-HB-Hib Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 4 and 6
PRP: Day 30 (>=0.15 mcg/mL)
|
100.0 percentage of participants
Interval 97.6 to 100.0
|
100.0 percentage of participants
Interval 94.7 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Immune Response Following Injection With DTaP-IPV-HB-Hib Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 4 and 6
PRP: Day 30 (>=1.0 mcg/mL)
|
100.0 percentage of participants
Interval 97.6 to 100.0
|
100.0 percentage of participants
Interval 94.7 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 0 and Day 30 post-vaccinationPopulation: Analysis was performed on PPAS. Data for this outcome measure were not planned to be collected and analyzed for Groups 1, 2, 3, 5, 7, 8, 9, 10, 11, and 12.
Pertussis and FHA vaccine response was defined as: if the pre-vaccination concentration is \< 4 \* lower limit of quantification (LLOQ is equal to 2), then the post-vaccination concentration is \>=4 \* pre-vaccination concentration and if the pre-vaccination concentration is \>= 4 \* LLOQ, then the post-vaccination concentration is \>= 2 \* pre-vaccination concentration.
Outcome measures
| Measure |
Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine
n=155 Participants
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) from South Korea and Thailand received single dose of MenACYW Conjugate vaccine, MMR vaccine, and varicella vaccine on Day 0.
|
Groups 2 and 11: MenACYW Conjugate Vaccine
n=68 Participants
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) from South Korea and Thailand received single dose of MenACYW Conjugate vaccine on Day 0.
|
Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine and DTaP-IPV-HB-Hib vaccine on Day 0.
|
Mexico (Group 5): MenACYW Conjugate Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
|
Russian Federation (Group 7): MenACYW Conjugate +PCV13 Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 15 to 23 months) received single dose of MenACYW Conjugate vaccine and PCV13 vaccine on Day 0.
|
Russian Federation (Group 8): MenACYW Conjugate Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 14 months or 16 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
|
Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine and DTaP-IPV-HB-Hib vaccine on Day 0.
|
Mexico (Group 5): MenACYW Conjugate Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
|
Mexico (Group 6): DTaP-IPV-HB-Hib Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of DTaP-IPV-HB-Hib Vaccine on Day 0.
|
Russian Federation (Group7): MenACYW Conjugate + PCV13 Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 15 to 23 months) received single dose of MenACYW Conjugate vaccine and PCV13 vaccine on Day 0.
|
Russian Federation (Group 8): MenACYW Conjugate Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 14 months or 16 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
|
Russian Federation (Group 9): PCV13 Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 15 to 23 months) received single dose of PCV13 vaccine on Day 0.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Vaccine Response of PT and FHA Antibodies Following Injection With DTaP-IPV-HB-Hib Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 4 and 6
PT: Day 30/Day 0
|
91.0 percentage of participants
Interval 85.3 to 95.0
|
92.6 percentage of participants
Interval 83.7 to 97.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Vaccine Response of PT and FHA Antibodies Following Injection With DTaP-IPV-HB-Hib Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 4 and 6
FHA: Day 30/Day 0
|
89.0 percentage of participants
Interval 83.0 to 93.5
|
88.2 percentage of participants
Interval 78.1 to 94.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 0 and Day 30 post-vaccinationPopulation: Analysis was performed on PPAS. Here, 'Number analyzed' = participants with available data for each specified category. Data for this outcome measure were not planned to be collected and analyzed for Groups 1, 2, 3, 4, 5, 6, 8, 10, 11, and 12.
Antibodies of pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F were measured by ECL assay.
Outcome measures
| Measure |
Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine
n=196 Participants
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) from South Korea and Thailand received single dose of MenACYW Conjugate vaccine, MMR vaccine, and varicella vaccine on Day 0.
|
Groups 2 and 11: MenACYW Conjugate Vaccine
n=92 Participants
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) from South Korea and Thailand received single dose of MenACYW Conjugate vaccine on Day 0.
|
Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine and DTaP-IPV-HB-Hib vaccine on Day 0.
|
Mexico (Group 5): MenACYW Conjugate Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
|
Russian Federation (Group 7): MenACYW Conjugate +PCV13 Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 15 to 23 months) received single dose of MenACYW Conjugate vaccine and PCV13 vaccine on Day 0.
|
Russian Federation (Group 8): MenACYW Conjugate Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 14 months or 16 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
|
Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine and DTaP-IPV-HB-Hib vaccine on Day 0.
|
Mexico (Group 5): MenACYW Conjugate Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
|
Mexico (Group 6): DTaP-IPV-HB-Hib Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of DTaP-IPV-HB-Hib Vaccine on Day 0.
|
Russian Federation (Group7): MenACYW Conjugate + PCV13 Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 15 to 23 months) received single dose of MenACYW Conjugate vaccine and PCV13 vaccine on Day 0.
|
Russian Federation (Group 8): MenACYW Conjugate Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 14 months or 16 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
|
Russian Federation (Group 9): PCV13 Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 15 to 23 months) received single dose of PCV13 vaccine on Day 0.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Titers of PCV13 Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F Antibodies Following Injection With PCV13 Vaccine Administrated Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9
Serotype 1: Day 0
|
0.867 titers (1/dilution)
Interval 0.741 to 1.01
|
0.918 titers (1/dilution)
Interval 0.713 to 1.18
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers of PCV13 Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F Antibodies Following Injection With PCV13 Vaccine Administrated Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9
Serotype 1: Day 30
|
2.33 titers (1/dilution)
Interval 1.98 to 2.75
|
2.14 titers (1/dilution)
Interval 1.63 to 2.81
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers of PCV13 Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F Antibodies Following Injection With PCV13 Vaccine Administrated Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9
Serotype 3: Day 0
|
0.409 titers (1/dilution)
Interval 0.341 to 0.491
|
0.414 titers (1/dilution)
Interval 0.322 to 0.533
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers of PCV13 Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F Antibodies Following Injection With PCV13 Vaccine Administrated Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9
Serotype 3: Day 30
|
0.802 titers (1/dilution)
Interval 0.664 to 0.967
|
0.773 titers (1/dilution)
Interval 0.608 to 0.983
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers of PCV13 Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F Antibodies Following Injection With PCV13 Vaccine Administrated Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9
Serotype 4: Day 0
|
0.604 titers (1/dilution)
Interval 0.511 to 0.715
|
0.653 titers (1/dilution)
Interval 0.507 to 0.84
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers of PCV13 Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F Antibodies Following Injection With PCV13 Vaccine Administrated Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9
Serotype 4: Day 30
|
1.97 titers (1/dilution)
Interval 1.68 to 2.31
|
1.49 titers (1/dilution)
Interval 1.15 to 1.93
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers of PCV13 Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F Antibodies Following Injection With PCV13 Vaccine Administrated Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9
Serotype 5: Day 0
|
0.828 titers (1/dilution)
Interval 0.719 to 0.953
|
0.782 titers (1/dilution)
Interval 0.61 to 1.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers of PCV13 Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F Antibodies Following Injection With PCV13 Vaccine Administrated Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9
Serotype 5: Day 30
|
1.99 titers (1/dilution)
Interval 1.7 to 2.31
|
1.73 titers (1/dilution)
Interval 1.33 to 2.24
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers of PCV13 Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F Antibodies Following Injection With PCV13 Vaccine Administrated Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9
Serotype 6A: Day 0
|
1.61 titers (1/dilution)
Interval 1.33 to 1.95
|
1.48 titers (1/dilution)
Interval 1.09 to 2.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers of PCV13 Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F Antibodies Following Injection With PCV13 Vaccine Administrated Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9
Serotype 6A: Day 30
|
5.96 titers (1/dilution)
Interval 4.99 to 7.13
|
6.13 titers (1/dilution)
Interval 4.47 to 8.41
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers of PCV13 Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F Antibodies Following Injection With PCV13 Vaccine Administrated Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9
Serotype 6B: Day 0
|
0.895 titers (1/dilution)
Interval 0.715 to 1.12
|
0.691 titers (1/dilution)
Interval 0.514 to 0.929
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers of PCV13 Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F Antibodies Following Injection With PCV13 Vaccine Administrated Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9
Serotype 6B: Day 30
|
3.66 titers (1/dilution)
Interval 2.99 to 4.5
|
2.57 titers (1/dilution)
Interval 1.83 to 3.61
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers of PCV13 Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F Antibodies Following Injection With PCV13 Vaccine Administrated Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9
Serotype 7F: Day 0
|
1.32 titers (1/dilution)
Interval 1.12 to 1.55
|
1.39 titers (1/dilution)
Interval 1.08 to 1.77
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers of PCV13 Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F Antibodies Following Injection With PCV13 Vaccine Administrated Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9
Serotype 7F: Day 30
|
3.05 titers (1/dilution)
Interval 2.59 to 3.58
|
2.67 titers (1/dilution)
Interval 2.05 to 3.47
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers of PCV13 Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F Antibodies Following Injection With PCV13 Vaccine Administrated Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9
Serotype 9V: Day 0
|
0.841 titers (1/dilution)
Interval 0.71 to 0.997
|
0.863 titers (1/dilution)
Interval 0.66 to 1.13
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers of PCV13 Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F Antibodies Following Injection With PCV13 Vaccine Administrated Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9
Serotype 9V: Day 30
|
2.34 titers (1/dilution)
Interval 1.95 to 2.81
|
2.52 titers (1/dilution)
Interval 1.92 to 3.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers of PCV13 Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F Antibodies Following Injection With PCV13 Vaccine Administrated Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9
Serotype 14: Day 0
|
3.25 titers (1/dilution)
Interval 2.74 to 3.86
|
3.00 titers (1/dilution)
Interval 2.3 to 3.91
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers of PCV13 Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F Antibodies Following Injection With PCV13 Vaccine Administrated Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9
Serotype 14: Day 30
|
7.62 titers (1/dilution)
Interval 6.56 to 8.83
|
6.30 titers (1/dilution)
Interval 5.0 to 7.93
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers of PCV13 Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F Antibodies Following Injection With PCV13 Vaccine Administrated Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9
Serotype 18C: Day 0
|
0.737 titers (1/dilution)
Interval 0.62 to 0.876
|
0.995 titers (1/dilution)
Interval 0.766 to 1.29
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers of PCV13 Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F Antibodies Following Injection With PCV13 Vaccine Administrated Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9
Serotype 18C: Day 30
|
2.19 titers (1/dilution)
Interval 1.87 to 2.58
|
2.21 titers (1/dilution)
Interval 1.73 to 2.83
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers of PCV13 Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F Antibodies Following Injection With PCV13 Vaccine Administrated Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9
Serotype 19A: Day 0
|
1.65 titers (1/dilution)
Interval 1.36 to 2.01
|
1.96 titers (1/dilution)
Interval 1.46 to 2.64
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers of PCV13 Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F Antibodies Following Injection With PCV13 Vaccine Administrated Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9
Serotype 19A: Day 30
|
5.75 titers (1/dilution)
Interval 4.85 to 6.8
|
5.91 titers (1/dilution)
Interval 4.54 to 7.69
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers of PCV13 Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F Antibodies Following Injection With PCV13 Vaccine Administrated Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9
Serotype 19F: Day 0
|
1.78 titers (1/dilution)
Interval 1.43 to 2.21
|
1.74 titers (1/dilution)
Interval 1.28 to 2.35
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers of PCV13 Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F Antibodies Following Injection With PCV13 Vaccine Administrated Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9
Serotype 19F: Day 30
|
5.58 titers (1/dilution)
Interval 4.57 to 6.81
|
5.53 titers (1/dilution)
Interval 3.98 to 7.69
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers of PCV13 Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F Antibodies Following Injection With PCV13 Vaccine Administrated Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9
Serotype 23F: Day 0
|
0.631 titers (1/dilution)
Interval 0.519 to 0.768
|
0.733 titers (1/dilution)
Interval 0.537 to 1.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers of PCV13 Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F Antibodies Following Injection With PCV13 Vaccine Administrated Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9
Serotype 23F: Day 30
|
2.42 titers (1/dilution)
Interval 2.04 to 2.86
|
2.58 titers (1/dilution)
Interval 1.98 to 3.37
|
—
|
—
|
—
|
—
|
—
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—
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—
|
—
|
—
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—
|
SECONDARY outcome
Timeframe: Day 0 and Day 30 post-vaccinationPopulation: Analysis was performed on PPAS. Here, 'Number analyzed' = participants with available data for each specified category. Data for this outcome measure were not planned to be collected and analyzed for Groups 1, 2, 3, 4, 5, 6, 8, 10, 11, and 12.
Immune response for PCV13 for serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F was defined as: antibodies concentrations \>=0.35 mcg/mL or \>=1.0 mcg/mL.
Outcome measures
| Measure |
Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine
n=196 Participants
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) from South Korea and Thailand received single dose of MenACYW Conjugate vaccine, MMR vaccine, and varicella vaccine on Day 0.
|
Groups 2 and 11: MenACYW Conjugate Vaccine
n=92 Participants
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) from South Korea and Thailand received single dose of MenACYW Conjugate vaccine on Day 0.
|
Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine and DTaP-IPV-HB-Hib vaccine on Day 0.
|
Mexico (Group 5): MenACYW Conjugate Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
|
Russian Federation (Group 7): MenACYW Conjugate +PCV13 Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 15 to 23 months) received single dose of MenACYW Conjugate vaccine and PCV13 vaccine on Day 0.
|
Russian Federation (Group 8): MenACYW Conjugate Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 14 months or 16 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
|
Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine and DTaP-IPV-HB-Hib vaccine on Day 0.
|
Mexico (Group 5): MenACYW Conjugate Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
|
Mexico (Group 6): DTaP-IPV-HB-Hib Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of DTaP-IPV-HB-Hib Vaccine on Day 0.
|
Russian Federation (Group7): MenACYW Conjugate + PCV13 Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 15 to 23 months) received single dose of MenACYW Conjugate vaccine and PCV13 vaccine on Day 0.
|
Russian Federation (Group 8): MenACYW Conjugate Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 14 months or 16 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
|
Russian Federation (Group 9): PCV13 Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 15 to 23 months) received single dose of PCV13 vaccine on Day 0.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9
Serotype 19F: Day 30 (>=1.0 mcg/mL)
|
88.0 percentage of participants
Interval 82.5 to 92.2
|
85.9 percentage of participants
Interval 77.0 to 92.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9
Serotype 18C: Day 0 (>=1.0 mcg/mL)
|
40.9 percentage of participants
Interval 33.9 to 48.2
|
48.9 percentage of participants
Interval 38.3 to 59.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9
Serotype 18C: Day 30 (>=0.35 mcg/mL)
|
95.3 percentage of participants
Interval 91.2 to 97.8
|
92.4 percentage of participants
Interval 84.9 to 96.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9
Serotype 18C: Day 30 (>=1.0 mcg/mL)
|
79.1 percentage of participants
Interval 72.6 to 84.6
|
79.3 percentage of participants
Interval 69.6 to 87.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9
Serotype 19A: Day 0 (>=0.35 mcg/mL)
|
87.0 percentage of participants
Interval 81.5 to 91.4
|
87.0 percentage of participants
Interval 78.3 to 93.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9
Serotype 19A: Day 0 (>=1.0 mcg/mL)
|
62.7 percentage of participants
Interval 55.5 to 69.5
|
69.6 percentage of participants
Interval 59.1 to 78.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9
Serotype 19A: Day 30 (>=0.35 mcg/mL)
|
96.3 percentage of participants
Interval 92.6 to 98.5
|
98.9 percentage of participants
Interval 94.1 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9
Serotype 19A: Day 30 (>=1.0 mcg/mL)
|
92.7 percentage of participants
Interval 88.0 to 95.9
|
90.2 percentage of participants
Interval 82.2 to 95.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9
Serotype 19F: Day 0 (>=0.35 mcg/mL)
|
87.0 percentage of participants
Interval 81.5 to 91.4
|
89.1 percentage of participants
Interval 80.9 to 94.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9
Serotype 19F: Day 0 (>=1.0 mcg/mL)
|
64.2 percentage of participants
Interval 57.0 to 71.0
|
65.2 percentage of participants
Interval 54.6 to 74.9
|
—
|
—
|
—
|
—
|
—
|
—
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—
|
—
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—
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—
|
|
Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9
Serotype 19F: Day 30 (>=0.35 mcg/mL)
|
96.9 percentage of participants
Interval 93.3 to 98.8
|
97.8 percentage of participants
Interval 92.4 to 99.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9
Serotype 23F: Day 0 (>=0.35 mcg/mL)
|
68.2 percentage of participants
Interval 61.1 to 74.7
|
64.1 percentage of participants
Interval 53.5 to 73.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9
Serotype 23F: Day 0 (>=1.0 mcg/mL)
|
34.9 percentage of participants
Interval 28.2 to 42.1
|
44.6 percentage of participants
Interval 34.2 to 55.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9
Serotype 23F: Day 30 (>=0.35 mcg/mL)
|
96.3 percentage of participants
Interval 92.6 to 98.5
|
93.5 percentage of participants
Interval 86.3 to 97.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9
Serotype 23F: Day 30 (>=1.0 mcg/mL)
|
72.3 percentage of participants
Interval 65.3 to 78.5
|
78.3 percentage of participants
Interval 68.4 to 86.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9
Serotype 1: Day 0 (>=0.35 mcg/mL)
|
80.8 percentage of participants
Interval 74.6 to 86.1
|
79.3 percentage of participants
Interval 69.6 to 87.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9
Serotype 1: Day 0 (>=1.0 mcg/mL)
|
43.0 percentage of participants
Interval 35.9 to 50.3
|
45.7 percentage of participants
Interval 35.2 to 56.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9
Serotype 1: Day 30 (>=0.35 mcg/mL)
|
97.4 percentage of participants
Interval 94.0 to 99.1
|
94.6 percentage of participants
Interval 87.8 to 98.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9
Serotype 1: Day 30 (>=1.0 mcg/mL)
|
76.4 percentage of participants
Interval 69.8 to 82.3
|
70.7 percentage of participants
Interval 60.2 to 79.7
|
—
|
—
|
—
|
—
|
—
|
—
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—
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—
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—
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—
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|
Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9
Serotype 3: Day 0 (>=0.35 mcg/mL)
|
49.2 percentage of participants
Interval 42.0 to 56.5
|
53.3 percentage of participants
Interval 42.6 to 63.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
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—
|
|
Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9
Serotype 3: Day 0 (>=1.0 mcg/mL)
|
22.3 percentage of participants
Interval 16.6 to 28.8
|
18.5 percentage of participants
Interval 11.1 to 27.9
|
—
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—
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—
|
—
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—
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—
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—
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—
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—
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—
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|
Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9
Serotype 3: Day 30 (>=0.35 mcg/mL)
|
72.3 percentage of participants
Interval 65.3 to 78.5
|
76.1 percentage of participants
Interval 66.1 to 84.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
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—
|
—
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—
|
|
Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9
Serotype 3: Day 30 (>=1.0 mcg/mL)
|
48.2 percentage of participants
Interval 40.9 to 55.5
|
38.0 percentage of participants
Interval 28.1 to 48.8
|
—
|
—
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—
|
—
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—
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—
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—
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—
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—
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—
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Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9
Serotype 4: Day 0 (>=0.35 mcg/mL)
|
66.8 percentage of participants
Interval 59.7 to 73.4
|
68.5 percentage of participants
Interval 58.0 to 77.8
|
—
|
—
|
—
|
—
|
—
|
—
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—
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—
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—
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—
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|
Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9
Serotype 4: Day 0 (>=1.0 mcg/mL)
|
33.7 percentage of participants
Interval 27.1 to 40.8
|
38.0 percentage of participants
Interval 28.1 to 48.8
|
—
|
—
|
—
|
—
|
—
|
—
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—
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—
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—
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—
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|
Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9
Serotype 4: Day 30 (>=0.35 mcg/mL)
|
92.7 percentage of participants
Interval 88.0 to 95.9
|
90.2 percentage of participants
Interval 82.2 to 95.4
|
—
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—
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—
|
—
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—
|
—
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—
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—
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—
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—
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|
Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9
Serotype 4: Day 30 (>=1.0 mcg/mL)
|
80.1 percentage of participants
Interval 73.7 to 85.5
|
62.0 percentage of participants
Interval 51.2 to 71.9
|
—
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—
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—
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—
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—
|
—
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—
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—
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—
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—
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|
Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9
Serotype 5: Day 0 (>=0.35 mcg/mL)
|
81.3 percentage of participants
Interval 75.1 to 86.6
|
76.1 percentage of participants
Interval 66.1 to 84.4
|
—
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—
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—
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—
|
—
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—
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—
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—
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—
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—
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|
Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9
Serotype 5: Day 0 (>=1.0 mcg/mL)
|
41.5 percentage of participants
Interval 34.4 to 48.7
|
50.0 percentage of participants
Interval 39.4 to 60.6
|
—
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—
|
—
|
—
|
—
|
—
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—
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—
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—
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—
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|
Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9
Serotype 5: Day 30 (>=0.35 mcg/mL)
|
94.8 percentage of participants
Interval 90.6 to 97.5
|
90.2 percentage of participants
Interval 82.2 to 95.4
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9
Serotype 5: Day 30 (>=1.0 mcg/mL)
|
71.2 percentage of participants
Interval 64.2 to 77.5
|
69.6 percentage of participants
Interval 59.1 to 78.7
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9
Serotype 6A: Day 0 (>=0.35 mcg/mL)
|
90.2 percentage of participants
Interval 85.1 to 94.0
|
82.6 percentage of participants
Interval 73.3 to 89.7
|
—
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—
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—
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—
|
—
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—
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—
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—
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—
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—
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|
Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9
Serotype 6A: Day 0 (>=1.0 mcg/mL)
|
63.7 percentage of participants
Interval 56.5 to 70.5
|
65.2 percentage of participants
Interval 54.6 to 74.9
|
—
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—
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—
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—
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—
|
—
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—
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—
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—
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—
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|
Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9
Serotype 6A: Day 30 (>=0.35 mcg/mL)
|
97.4 percentage of participants
Interval 94.0 to 99.1
|
96.7 percentage of participants
Interval 90.8 to 99.3
|
—
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—
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—
|
—
|
—
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—
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—
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—
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—
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—
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|
Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9
Serotype 6A: Day 30 (>=1.0 mcg/mL)
|
96.3 percentage of participants
Interval 92.6 to 98.5
|
90.2 percentage of participants
Interval 82.2 to 95.4
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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|
Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9
Serotype 6B: Day 0 (>=0.35 mcg/mL)
|
72.0 percentage of participants
Interval 65.1 to 78.2
|
68.5 percentage of participants
Interval 58.0 to 77.8
|
—
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—
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—
|
—
|
—
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—
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—
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—
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—
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—
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|
Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9
Serotype 6B: Day 0 (>=1.0 mcg/mL)
|
44.6 percentage of participants
Interval 37.4 to 51.9
|
41.3 percentage of participants
Interval 31.1 to 52.1
|
—
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—
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—
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—
|
—
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—
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—
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—
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—
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—
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|
Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9
Serotype 6B: Day 30 (>=0.35 mcg/mL)
|
94.8 percentage of participants
Interval 90.6 to 97.5
|
92.4 percentage of participants
Interval 84.9 to 96.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
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—
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|
Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9
Serotype 6B: Day 30 (>=1.0 mcg/mL)
|
86.4 percentage of participants
Interval 80.7 to 90.9
|
75.0 percentage of participants
Interval 64.9 to 83.4
|
—
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—
|
—
|
—
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—
|
—
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—
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—
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—
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—
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|
Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9
Serotype 7F: Day 0 (>=0.35 mcg/mL)
|
87.0 percentage of participants
Interval 81.5 to 91.4
|
88.0 percentage of participants
Interval 79.6 to 93.9
|
—
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—
|
—
|
—
|
—
|
—
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—
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—
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—
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—
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|
Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9
Serotype 7F: Day 0 (>=1.0 mcg/mL)
|
62.7 percentage of participants
Interval 55.5 to 69.5
|
65.2 percentage of participants
Interval 54.6 to 74.9
|
—
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—
|
—
|
—
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—
|
—
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—
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—
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—
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—
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|
Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9
Serotype 7F: Day 30 (>=0.35 mcg/mL)
|
98.4 percentage of participants
Interval 95.5 to 99.7
|
94.6 percentage of participants
Interval 87.8 to 98.2
|
—
|
—
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—
|
—
|
—
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—
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—
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—
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—
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—
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|
Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9
Serotype 7F: Day 30 (>=1.0 mcg/mL)
|
80.1 percentage of participants
Interval 73.7 to 85.5
|
83.7 percentage of participants
Interval 74.5 to 90.6
|
—
|
—
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—
|
—
|
—
|
—
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—
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—
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—
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—
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Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9
Serotype 9V: Day 0 (>=0.35 mcg/mL)
|
77.2 percentage of participants
Interval 70.6 to 82.9
|
79.3 percentage of participants
Interval 69.6 to 87.1
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9
Serotype 9V: Day 0 (>=1.0 mcg/mL)
|
42.0 percentage of participants
Interval 34.9 to 49.3
|
43.5 percentage of participants
Interval 33.2 to 54.2
|
—
|
—
|
—
|
—
|
—
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—
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—
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—
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—
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—
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Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9
Serotype 9V: Day 30 (>=0.35 mcg/mL)
|
95.3 percentage of participants
Interval 91.2 to 97.8
|
92.4 percentage of participants
Interval 84.9 to 96.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
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—
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—
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—
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|
Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9
Serotype 9V: Day 30 (>=1.0 microg/mL)
|
74.3 percentage of participants
Interval 67.5 to 80.4
|
75.0 percentage of participants
Interval 64.9 to 83.4
|
—
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—
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—
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—
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—
|
—
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—
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—
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—
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—
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Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9
Serotype 14: Day 0 (>=0.35 mcg/mL)
|
95.8 percentage of participants
Interval 92.0 to 98.2
|
92.4 percentage of participants
Interval 84.9 to 96.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
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—
|
|
Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9
Serotype 14: Day 0 (>=1.0 mcg/mL)
|
83.3 percentage of participants
Interval 77.3 to 88.3
|
87.0 percentage of participants
Interval 78.3 to 93.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
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—
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—
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—
|
|
Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9
Serotype 14: Day 30 (>=0.35 mcg/mL)
|
99.0 percentage of participants
Interval 96.3 to 99.9
|
98.9 percentage of participants
Interval 94.1 to 100.0
|
—
|
—
|
—
|
—
|
—
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—
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—
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—
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—
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—
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|
Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9
Serotype 14: Day 30 (>=1.0 mcg/mL)
|
97.4 percentage of participants
Interval 94.0 to 99.1
|
94.6 percentage of participants
Interval 87.8 to 98.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
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—
|
—
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—
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|
Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9
Serotype 18C: Day 0 (>=0.35 mcg/mL)
|
71.5 percentage of participants
Interval 64.6 to 77.8
|
84.8 percentage of participants
Interval 75.8 to 91.4
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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SECONDARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on Safety analysis set (SafAS) which included participants who received at least 1 dose of study vaccine(s) \& had any safety data available. Here '0' in the number analyzed field signifies that the vaccines mentioned in the respective categories were not administered to the specified group.
Solicited Reaction (SR) was defined as an adverse event (AE) that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). Solicited injection site reactions: tenderness, erythema, and swelling. Tenderness: Grade 3: cries when injected limb moved or the movement of the injected limb reduced, Erythema and swelling: Grade 3: \>= 50 millimeter (mm). Participants with any of the Grade and Grade 3 solicited injection-site reactions were reported.
Outcome measures
| Measure |
Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine
n=103 Participants
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) from South Korea and Thailand received single dose of MenACYW Conjugate vaccine, MMR vaccine, and varicella vaccine on Day 0.
|
Groups 2 and 11: MenACYW Conjugate Vaccine
n=52 Participants
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) from South Korea and Thailand received single dose of MenACYW Conjugate vaccine on Day 0.
|
Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine
n=53 Participants
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine and DTaP-IPV-HB-Hib vaccine on Day 0.
|
Mexico (Group 5): MenACYW Conjugate Vaccine
n=86 Participants
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
|
Russian Federation (Group 7): MenACYW Conjugate +PCV13 Vaccine
n=42 Participants
Healthy, meningococcal-vaccine naïve toddlers (aged 15 to 23 months) received single dose of MenACYW Conjugate vaccine and PCV13 vaccine on Day 0.
|
Russian Federation (Group 8): MenACYW Conjugate Vaccine
n=42 Participants
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 14 months or 16 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
|
Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine and DTaP-IPV-HB-Hib vaccine on Day 0.
|
Mexico (Group 5): MenACYW Conjugate Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
|
Mexico (Group 6): DTaP-IPV-HB-Hib Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of DTaP-IPV-HB-Hib Vaccine on Day 0.
|
Russian Federation (Group7): MenACYW Conjugate + PCV13 Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 15 to 23 months) received single dose of MenACYW Conjugate vaccine and PCV13 vaccine on Day 0.
|
Russian Federation (Group 8): MenACYW Conjugate Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 14 months or 16 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
|
Russian Federation (Group 9): PCV13 Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 15 to 23 months) received single dose of PCV13 vaccine on Day 0.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 1, 2, 3, 10, 11, and 12
MenACYW: Tenderness: Any Grade
|
28 Participants
|
15 Participants
|
—
|
29 Participants
|
17 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 1, 2, 3, 10, 11, and 12
MenACYW: Tenderness: Grade 3
|
1 Participants
|
0 Participants
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 1, 2, 3, 10, 11, and 12
MenACYW: Erythema: Any Grade
|
27 Participants
|
20 Participants
|
—
|
29 Participants
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 1, 2, 3, 10, 11, and 12
MenACYW: Erythema: Grade 3
|
0 Participants
|
2 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 1, 2, 3, 10, 11, and 12
MenACYW: Swelling: Any Grade
|
18 Participants
|
14 Participants
|
—
|
15 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 1, 2, 3, 10, 11, and 12
MenACYW: Swelling: Grade 3
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 1, 2, 3, 10, 11, and 12
MMR: Tenderness: Any Grade
|
21 Participants
|
—
|
10 Participants
|
17 Participants
|
—
|
18 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 1, 2, 3, 10, 11, and 12
MMR: Tenderness: Grade 3
|
1 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 1, 2, 3, 10, 11, and 12
MMR: Erythema: Any Grade
|
13 Participants
|
—
|
6 Participants
|
24 Participants
|
—
|
10 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 1, 2, 3, 10, 11, and 12
MMR: Erythema: Grade 3
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 1, 2, 3, 10, 11, and 12
MMR: Swelling: Any Grade
|
7 Participants
|
—
|
1 Participants
|
11 Participants
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 1, 2, 3, 10, 11, and 12
MMR: Swelling: Grade 3
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 1, 2, 3, 10, 11, and 12
Varicella: Tenderness: Any Grade
|
23 Participants
|
—
|
11 Participants
|
17 Participants
|
—
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 1, 2, 3, 10, 11, and 12
Varicella: Tenderness: Grade 3
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 1, 2, 3, 10, 11, and 12
Varicella: Erythema: Any Grade
|
19 Participants
|
—
|
4 Participants
|
18 Participants
|
—
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 1, 2, 3, 10, 11, and 12
Varicella: Erythema: Grade 3
|
1 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 1, 2, 3, 10, 11, and 12
Varicella: Swelling: Any Grade
|
10 Participants
|
—
|
2 Participants
|
12 Participants
|
—
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 1, 2, 3, 10, 11, and 12
Varicella: Swelling: Grade 3
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on SafAS. Here, 'Number analyzed' = participants with available data for each specified category and '0' in the number analyzed field signifies that the vaccines mentioned in the respective categories were not administered to the specified group.
SR was defined as an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). Solicited injection site reactions: tenderness, erythema, and swelling. Tenderness: Grade 3: cries when injected limb moved or the movement of the injected limb reduced, Erythema and swelling: Grade 3: \>= 50 mm. Participants with any of the Grade and Grade 3 solicited injection-site reactions were reported.
Outcome measures
| Measure |
Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine
n=200 Participants
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) from South Korea and Thailand received single dose of MenACYW Conjugate vaccine, MMR vaccine, and varicella vaccine on Day 0.
|
Groups 2 and 11: MenACYW Conjugate Vaccine
n=100 Participants
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) from South Korea and Thailand received single dose of MenACYW Conjugate vaccine on Day 0.
|
Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine
n=100 Participants
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine and DTaP-IPV-HB-Hib vaccine on Day 0.
|
Mexico (Group 5): MenACYW Conjugate Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
|
Russian Federation (Group 7): MenACYW Conjugate +PCV13 Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 15 to 23 months) received single dose of MenACYW Conjugate vaccine and PCV13 vaccine on Day 0.
|
Russian Federation (Group 8): MenACYW Conjugate Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 14 months or 16 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
|
Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine and DTaP-IPV-HB-Hib vaccine on Day 0.
|
Mexico (Group 5): MenACYW Conjugate Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
|
Mexico (Group 6): DTaP-IPV-HB-Hib Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of DTaP-IPV-HB-Hib Vaccine on Day 0.
|
Russian Federation (Group7): MenACYW Conjugate + PCV13 Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 15 to 23 months) received single dose of MenACYW Conjugate vaccine and PCV13 vaccine on Day 0.
|
Russian Federation (Group 8): MenACYW Conjugate Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 14 months or 16 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
|
Russian Federation (Group 9): PCV13 Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 15 to 23 months) received single dose of PCV13 vaccine on Day 0.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 4, 5, and 6
MenACYW: Tenderness: Any Grade
|
68 Participants
|
27 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 4, 5, and 6
MenACYW: Tenderness: Grade 3
|
6 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 4, 5, and 6
MenACYW: Erythema: Any Grade
|
40 Participants
|
15 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 4, 5, and 6
MenACYW: Erythema: Grade 3
|
3 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 4, 5, and 6
MenACYW: Swelling: Any Grade
|
23 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 4, 5, and 6
MenACYW: Swelling: Grade 3
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 4, 5, and 6
DTaP-IPV-HB-Hib: Tenderness: Any Grade
|
80 Participants
|
—
|
54 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 4, 5, and 6
DTaP-IPV-HB-Hib: Tenderness: Grade 3
|
6 Participants
|
—
|
10 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 4, 5, and 6
DTaP-IPV-HB-Hib: Erythema: Any Grade
|
56 Participants
|
—
|
37 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 4, 5, and 6
DTaP-IPV-HB-Hib: Erythema: Grade 3
|
8 Participants
|
—
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 4, 5, and 6
DTaP-IPV-HB-Hib: Swelling: Any Grade
|
45 Participants
|
—
|
30 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 4, 5, and 6
DTaP-IPV-HB-Hib: Swelling: Grade 3
|
8 Participants
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on SafAS. Here, '0' in the number analyzed field signifies that the vaccines mentioned in the respective categories were not administered to the specified group.
SR was defined as an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). Solicited injection site reactions: tenderness, erythema, and swelling. Tenderness: Grade 3: cries when injected limb moved, or the movement of the injected limb reduced, Erythema and swelling: Grade 3: \>= 50 mm. Participants with any of the Grade and Grade 3 solicited injection-site reactions were reported.
Outcome measures
| Measure |
Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine
n=200 Participants
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) from South Korea and Thailand received single dose of MenACYW Conjugate vaccine, MMR vaccine, and varicella vaccine on Day 0.
|
Groups 2 and 11: MenACYW Conjugate Vaccine
n=100 Participants
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) from South Korea and Thailand received single dose of MenACYW Conjugate vaccine on Day 0.
|
Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine
n=99 Participants
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine and DTaP-IPV-HB-Hib vaccine on Day 0.
|
Mexico (Group 5): MenACYW Conjugate Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
|
Russian Federation (Group 7): MenACYW Conjugate +PCV13 Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 15 to 23 months) received single dose of MenACYW Conjugate vaccine and PCV13 vaccine on Day 0.
|
Russian Federation (Group 8): MenACYW Conjugate Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 14 months or 16 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
|
Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine and DTaP-IPV-HB-Hib vaccine on Day 0.
|
Mexico (Group 5): MenACYW Conjugate Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
|
Mexico (Group 6): DTaP-IPV-HB-Hib Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of DTaP-IPV-HB-Hib Vaccine on Day 0.
|
Russian Federation (Group7): MenACYW Conjugate + PCV13 Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 15 to 23 months) received single dose of MenACYW Conjugate vaccine and PCV13 vaccine on Day 0.
|
Russian Federation (Group 8): MenACYW Conjugate Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 14 months or 16 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
|
Russian Federation (Group 9): PCV13 Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 15 to 23 months) received single dose of PCV13 vaccine on Day 0.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 7, 8, and 9
MenACYW: Tenderness: Any Grade
|
28 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 7, 8, and 9
MenACYW: Tenderness: Grade 3
|
4 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 7, 8, and 9
MenACYW: Erythema: Any Grade
|
43 Participants
|
17 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 7, 8, and 9
MenACYW: Erythema: Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 7, 8, and 9
MenACYW: Swelling: Any Grade
|
8 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 7, 8, and 9
MenACYW: Swelling: Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 7, 8, and 9
PCV13: Tenderness: Any Grade
|
34 Participants
|
—
|
9 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 7, 8, and 9
PCV13: Tenderness: Grade 3
|
5 Participants
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 7, 8, and 9
PCV13: Erythema: Any Grade
|
48 Participants
|
—
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 7, 8, and 9
PCV13: Erythema: Grade 3
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 7, 8, and 9
PCV13: Swelling: Any Grade
|
19 Participants
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 7, 8, and 9
PCV13: Swelling: Grade 3
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on Safety analysis set. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
SR was defined as an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). Solicited systemic reaction: Fever: Grade 3: \> 39.5 degree Celsius, Vomiting: Grade 3: \>= 6 episodes per 24 hours or requiring parenteral hydration, Crying abnormal: Grade 3: \> 3 hours, Drowsiness: Grade 3: sleeping most of the time or difficult to wake up, Appetite lost: Grade 3: refuses \>= 3 feeds/meals or refuses most feeds/meals, Irritability: Grade 3: inconsolable. Participants with any of the Grade and Grade 3 solicited systemic reactions were reported.
Outcome measures
| Measure |
Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine
n=103 Participants
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) from South Korea and Thailand received single dose of MenACYW Conjugate vaccine, MMR vaccine, and varicella vaccine on Day 0.
|
Groups 2 and 11: MenACYW Conjugate Vaccine
n=52 Participants
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) from South Korea and Thailand received single dose of MenACYW Conjugate vaccine on Day 0.
|
Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine
n=53 Participants
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine and DTaP-IPV-HB-Hib vaccine on Day 0.
|
Mexico (Group 5): MenACYW Conjugate Vaccine
n=86 Participants
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
|
Russian Federation (Group 7): MenACYW Conjugate +PCV13 Vaccine
n=42 Participants
Healthy, meningococcal-vaccine naïve toddlers (aged 15 to 23 months) received single dose of MenACYW Conjugate vaccine and PCV13 vaccine on Day 0.
|
Russian Federation (Group 8): MenACYW Conjugate Vaccine
n=42 Participants
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 14 months or 16 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
|
Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine
n=191 Participants
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine and DTaP-IPV-HB-Hib vaccine on Day 0.
|
Mexico (Group 5): MenACYW Conjugate Vaccine
n=98 Participants
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
|
Mexico (Group 6): DTaP-IPV-HB-Hib Vaccine
n=95 Participants
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of DTaP-IPV-HB-Hib Vaccine on Day 0.
|
Russian Federation (Group7): MenACYW Conjugate + PCV13 Vaccine
n=200 Participants
Healthy, meningococcal-vaccine naïve toddlers (aged 15 to 23 months) received single dose of MenACYW Conjugate vaccine and PCV13 vaccine on Day 0.
|
Russian Federation (Group 8): MenACYW Conjugate Vaccine
n=100 Participants
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 14 months or 16 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
|
Russian Federation (Group 9): PCV13 Vaccine
n=99 Participants
Healthy, meningococcal-vaccine naïve toddlers (aged 15 to 23 months) received single dose of PCV13 vaccine on Day 0.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability)
Appetite Lost: Any Grade
|
29 Participants
|
10 Participants
|
8 Participants
|
11 Participants
|
12 Participants
|
5 Participants
|
51 Participants
|
25 Participants
|
20 Participants
|
19 Participants
|
12 Participants
|
7 Participants
|
|
Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability)
Fever: Any Grade
|
17 Participants
|
9 Participants
|
5 Participants
|
6 Participants
|
1 Participants
|
3 Participants
|
32 Participants
|
7 Participants
|
16 Participants
|
12 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability)
Fever: Grade 3
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability)
Vomiting: Any Grade
|
6 Participants
|
3 Participants
|
2 Participants
|
5 Participants
|
4 Participants
|
5 Participants
|
15 Participants
|
6 Participants
|
9 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability)
Vomiting: Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability)
Abnormal crying: Any Grade
|
21 Participants
|
9 Participants
|
6 Participants
|
14 Participants
|
17 Participants
|
12 Participants
|
46 Participants
|
25 Participants
|
26 Participants
|
8 Participants
|
4 Participants
|
2 Participants
|
|
Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability)
Abnormal crying: Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability)
Drowsiness: Any Grade
|
17 Participants
|
8 Participants
|
9 Participants
|
8 Participants
|
7 Participants
|
7 Participants
|
31 Participants
|
15 Participants
|
17 Participants
|
25 Participants
|
6 Participants
|
4 Participants
|
|
Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability)
Drowsiness: Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability)
Appetite Lost: Grade 3
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
8 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability)
Irritability: Any Grade
|
31 Participants
|
12 Participants
|
11 Participants
|
14 Participants
|
11 Participants
|
14 Participants
|
64 Participants
|
34 Participants
|
33 Participants
|
26 Participants
|
16 Participants
|
9 Participants
|
|
Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability)
Irritability: Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
3 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
South Korea(Group1):MenACYW Conjugate +MMR +Varicella Vaccine
Serious events: 6 serious events
Other events: 85 other events
Deaths: 0 deaths
South Korea (Group 2): MenACYW Conjugate Vaccine
Serious events: 4 serious events
Other events: 43 other events
Deaths: 0 deaths
South Korea (Group 3): MMR + Varicella Vaccine
Serious events: 2 serious events
Other events: 37 other events
Deaths: 0 deaths
Thailand (Group 10):MenACYW Conjugate + MMR +Varicella Vaccine
Serious events: 0 serious events
Other events: 58 other events
Deaths: 0 deaths
Thailand (Group 11): MenACYW Conjugate Vaccine
Serious events: 1 serious events
Other events: 37 other events
Deaths: 0 deaths
Thailand (Group 12): MMR + Varicella Vaccine
Serious events: 0 serious events
Other events: 37 other events
Deaths: 0 deaths
Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine
Serious events: 0 serious events
Other events: 142 other events
Deaths: 0 deaths
Mexico (Group 5): MenACYW Conjugate Vaccine
Serious events: 0 serious events
Other events: 65 other events
Deaths: 0 deaths
Mexico (Group 6): DTaP-IPV-HB-Hib Vaccine
Serious events: 1 serious events
Other events: 85 other events
Deaths: 0 deaths
Russian Federation (Group 7):MenACYW Conjugate + PCV13 Vaccine
Serious events: 0 serious events
Other events: 75 other events
Deaths: 0 deaths
Russian Federation (Group 8): MenACYW Conjugate Vaccine
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
Russian Federation (Group 9): PCV13 Vaccine
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
South Korea(Group1):MenACYW Conjugate +MMR +Varicella Vaccine
n=103 participants at risk
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine, MMR vaccine, and varicella vaccine on Day 0.
|
South Korea (Group 2): MenACYW Conjugate Vaccine
n=52 participants at risk
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
|
South Korea (Group 3): MMR + Varicella Vaccine
n=53 participants at risk
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MMR vaccine and varicella vaccine on Day 0.
|
Thailand (Group 10):MenACYW Conjugate + MMR +Varicella Vaccine
n=86 participants at risk
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine, MMR vaccine, and varicella vaccine on Day 0.
|
Thailand (Group 11): MenACYW Conjugate Vaccine
n=42 participants at risk
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
|
Thailand (Group 12): MMR + Varicella Vaccine
n=42 participants at risk
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MMR vaccine and varicella vaccine on Day 0.
|
Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine
n=200 participants at risk
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine and DTaP-IPV-HB-Hib vaccine on Day 0.
|
Mexico (Group 5): MenACYW Conjugate Vaccine
n=100 participants at risk
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
|
Mexico (Group 6): DTaP-IPV-HB-Hib Vaccine
n=100 participants at risk
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of DTaP-IPV-HB-Hib Vaccine on Day 0.
|
Russian Federation (Group 7):MenACYW Conjugate + PCV13 Vaccine
n=200 participants at risk
Healthy, meningococcal-vaccine naïve toddlers (aged 15 to 23 months) received single dose of MenACYW Conjugate and PCV13 Vaccine on Day 0.
|
Russian Federation (Group 8): MenACYW Conjugate Vaccine
n=100 participants at risk
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 14 months or 16 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
|
Russian Federation (Group 9): PCV13 Vaccine
n=99 participants at risk
Healthy, meningococcal-vaccine naïve toddlers (aged 15 to 23 months) received single dose of PCV13 Vaccine on Day 0.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/103 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
3.8%
2/52 • Number of events 2 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/53 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/86 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/42 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/42 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/200 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/100 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/100 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/200 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/100 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/99 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/103 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
1.9%
1/52 • Number of events 1 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/53 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/86 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/42 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/42 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/200 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/100 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/100 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/200 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/100 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/99 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
|
Infections and infestations
Bronchitis Viral
|
1.9%
2/103 • Number of events 2 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/52 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/53 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/86 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/42 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/42 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/200 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/100 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/100 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/200 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/100 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/99 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
|
Infections and infestations
Croup Infectious
|
0.00%
0/103 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/52 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/53 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/86 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
2.4%
1/42 • Number of events 1 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/42 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/200 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/100 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/100 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/200 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/100 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/99 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
|
Infections and infestations
Gastroenteritis
|
0.97%
1/103 • Number of events 1 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
1.9%
1/52 • Number of events 1 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/53 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/86 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/42 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/42 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/200 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/100 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/100 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/200 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/100 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/99 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
|
Infections and infestations
Hand-Foot-And-Mouth Disease
|
0.97%
1/103 • Number of events 1 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
1.9%
1/52 • Number of events 1 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/53 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/86 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/42 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/42 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/200 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/100 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/100 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/200 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/100 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/99 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
|
Infections and infestations
Otitis Media Viral
|
0.00%
0/103 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/52 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
1.9%
1/53 • Number of events 1 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/86 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/42 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/42 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/200 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/100 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/100 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/200 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/100 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/99 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
|
Infections and infestations
Pneumonia Viral
|
0.00%
0/103 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/52 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
1.9%
1/53 • Number of events 1 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/86 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/42 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/42 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/200 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/100 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/100 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/200 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/100 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/99 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
|
Infections and infestations
Respiratory Syncytial Virus Bronchiolitis
|
0.97%
1/103 • Number of events 1 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/52 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/53 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/86 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/42 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/42 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/200 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/100 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/100 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/200 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/100 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/99 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
|
Infections and infestations
Tonsillitis
|
0.97%
1/103 • Number of events 1 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/52 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/53 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/86 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/42 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/42 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/200 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/100 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/100 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/200 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/100 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/99 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
|
Nervous system disorders
Febrile Convulsion
|
0.00%
0/103 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/52 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/53 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/86 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/42 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/42 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/200 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/100 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
1.0%
1/100 • Number of events 1 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/200 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/100 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/99 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/103 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/52 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/53 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/86 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/42 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/42 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/200 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/100 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
1.0%
1/100 • Number of events 2 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/200 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/100 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/99 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
Other adverse events
| Measure |
South Korea(Group1):MenACYW Conjugate +MMR +Varicella Vaccine
n=103 participants at risk
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine, MMR vaccine, and varicella vaccine on Day 0.
|
South Korea (Group 2): MenACYW Conjugate Vaccine
n=52 participants at risk
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
|
South Korea (Group 3): MMR + Varicella Vaccine
n=53 participants at risk
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MMR vaccine and varicella vaccine on Day 0.
|
Thailand (Group 10):MenACYW Conjugate + MMR +Varicella Vaccine
n=86 participants at risk
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine, MMR vaccine, and varicella vaccine on Day 0.
|
Thailand (Group 11): MenACYW Conjugate Vaccine
n=42 participants at risk
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
|
Thailand (Group 12): MMR + Varicella Vaccine
n=42 participants at risk
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MMR vaccine and varicella vaccine on Day 0.
|
Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine
n=200 participants at risk
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine and DTaP-IPV-HB-Hib vaccine on Day 0.
|
Mexico (Group 5): MenACYW Conjugate Vaccine
n=100 participants at risk
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
|
Mexico (Group 6): DTaP-IPV-HB-Hib Vaccine
n=100 participants at risk
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of DTaP-IPV-HB-Hib Vaccine on Day 0.
|
Russian Federation (Group 7):MenACYW Conjugate + PCV13 Vaccine
n=200 participants at risk
Healthy, meningococcal-vaccine naïve toddlers (aged 15 to 23 months) received single dose of MenACYW Conjugate and PCV13 Vaccine on Day 0.
|
Russian Federation (Group 8): MenACYW Conjugate Vaccine
n=100 participants at risk
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 14 months or 16 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
|
Russian Federation (Group 9): PCV13 Vaccine
n=99 participants at risk
Healthy, meningococcal-vaccine naïve toddlers (aged 15 to 23 months) received single dose of PCV13 Vaccine on Day 0.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
2.9%
3/103 • Number of events 3 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
3.8%
2/52 • Number of events 2 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/53 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
1.2%
1/86 • Number of events 1 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/42 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/42 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
6.0%
12/200 • Number of events 13 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
5.0%
5/100 • Number of events 6 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
6.0%
6/100 • Number of events 6 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/200 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
1.0%
1/100 • Number of events 1 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/99 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
|
Gastrointestinal disorders
Vomiting
|
6.8%
7/103 • Number of events 7 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
5.8%
3/52 • Number of events 3 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
3.8%
2/53 • Number of events 2 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
7.0%
6/86 • Number of events 6 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
9.5%
4/42 • Number of events 4 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
14.3%
6/42 • Number of events 6 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
8.0%
16/200 • Number of events 17 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
7.0%
7/100 • Number of events 7 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
9.0%
9/100 • Number of events 9 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/200 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/100 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/99 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
|
General disorders
Crying
|
20.4%
21/103 • Number of events 21 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
17.3%
9/52 • Number of events 9 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
11.3%
6/53 • Number of events 6 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
17.4%
15/86 • Number of events 15 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
40.5%
17/42 • Number of events 17 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
28.6%
12/42 • Number of events 12 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
23.0%
46/200 • Number of events 46 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
25.0%
25/100 • Number of events 25 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
26.0%
26/100 • Number of events 26 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
4.0%
8/200 • Number of events 8 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
4.0%
4/100 • Number of events 4 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
2.0%
2/99 • Number of events 2 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
|
General disorders
Injection Site Erythema
|
34.0%
35/103 • Number of events 60 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
38.5%
20/52 • Number of events 20 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
15.1%
8/53 • Number of events 10 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
41.9%
36/86 • Number of events 71 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
31.0%
13/42 • Number of events 13 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
38.1%
16/42 • Number of events 23 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
33.5%
67/200 • Number of events 96 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
15.0%
15/100 • Number of events 15 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
37.0%
37/100 • Number of events 37 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
27.5%
55/200 • Number of events 91 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
17.0%
17/100 • Number of events 17 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
8.1%
8/99 • Number of events 8 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
|
General disorders
Injection Site Pain
|
30.1%
31/103 • Number of events 72 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
28.8%
15/52 • Number of events 15 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
22.6%
12/53 • Number of events 21 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
36.0%
31/86 • Number of events 63 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
40.5%
17/42 • Number of events 17 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
45.2%
19/42 • Number of events 32 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
43.5%
87/200 • Number of events 148 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
27.0%
27/100 • Number of events 27 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
54.0%
54/100 • Number of events 54 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
18.5%
37/200 • Number of events 62 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
8.0%
8/100 • Number of events 8 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
9.1%
9/99 • Number of events 9 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
|
General disorders
Injection Site Swelling
|
24.3%
25/103 • Number of events 35 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
26.9%
14/52 • Number of events 14 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
5.7%
3/53 • Number of events 3 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
20.9%
18/86 • Number of events 38 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
16.7%
7/42 • Number of events 7 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
11.9%
5/42 • Number of events 9 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
26.0%
52/200 • Number of events 68 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
8.0%
8/100 • Number of events 8 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
30.0%
30/100 • Number of events 30 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
10.5%
21/200 • Number of events 27 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
7.0%
7/100 • Number of events 7 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
2.0%
2/99 • Number of events 2 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
|
General disorders
Pyrexia
|
20.4%
21/103 • Number of events 21 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
21.2%
11/52 • Number of events 12 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
18.9%
10/53 • Number of events 12 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
7.0%
6/86 • Number of events 6 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
7.1%
3/42 • Number of events 3 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
9.5%
4/42 • Number of events 4 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
17.5%
35/200 • Number of events 35 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
8.0%
8/100 • Number of events 8 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
17.0%
17/100 • Number of events 17 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
6.5%
13/200 • Number of events 13 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
3.0%
3/100 • Number of events 3 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
2.0%
2/99 • Number of events 3 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
|
Infections and infestations
Bronchitis
|
3.9%
4/103 • Number of events 4 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
1.9%
1/52 • Number of events 1 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
7.5%
4/53 • Number of events 5 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
1.2%
1/86 • Number of events 1 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/42 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
2.4%
1/42 • Number of events 1 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/200 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/100 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/100 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.50%
1/200 • Number of events 1 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/100 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
1.0%
1/99 • Number of events 1 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
|
Infections and infestations
Nasopharyngitis
|
28.2%
29/103 • Number of events 37 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
32.7%
17/52 • Number of events 23 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
24.5%
13/53 • Number of events 18 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
5.8%
5/86 • Number of events 5 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
7.1%
3/42 • Number of events 4 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
14.3%
6/42 • Number of events 7 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
14.5%
29/200 • Number of events 31 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
18.0%
18/100 • Number of events 18 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
15.0%
15/100 • Number of events 16 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
1.0%
2/200 • Number of events 2 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
1.0%
1/100 • Number of events 1 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/99 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
|
Infections and infestations
Pharyngitis
|
0.97%
1/103 • Number of events 1 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
3.8%
2/52 • Number of events 2 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
5.7%
3/53 • Number of events 4 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
2.3%
2/86 • Number of events 2 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
2.4%
1/42 • Number of events 1 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
4.8%
2/42 • Number of events 2 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
4.5%
9/200 • Number of events 9 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
6.0%
6/100 • Number of events 6 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
4.0%
4/100 • Number of events 4 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/200 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/100 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/99 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/103 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
1.9%
1/52 • Number of events 1 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/53 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/86 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/42 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
2.4%
1/42 • Number of events 1 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/200 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/100 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/100 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
1.5%
3/200 • Number of events 3 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
6.0%
6/100 • Number of events 6 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
1.0%
1/99 • Number of events 1 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
5.8%
6/103 • Number of events 7 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
5.8%
3/52 • Number of events 3 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/53 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
3.5%
3/86 • Number of events 3 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
4.8%
2/42 • Number of events 2 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
9.5%
4/42 • Number of events 4 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
3.0%
6/200 • Number of events 6 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
1.0%
1/100 • Number of events 1 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/100 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/200 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/100 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/99 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
28.2%
29/103 • Number of events 29 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
19.2%
10/52 • Number of events 10 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
15.1%
8/53 • Number of events 8 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
12.8%
11/86 • Number of events 11 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
28.6%
12/42 • Number of events 12 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
11.9%
5/42 • Number of events 5 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
25.5%
51/200 • Number of events 51 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
25.0%
25/100 • Number of events 25 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
20.0%
20/100 • Number of events 20 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
9.5%
19/200 • Number of events 19 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
12.0%
12/100 • Number of events 12 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
7.1%
7/99 • Number of events 7 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
|
Nervous system disorders
Somnolence
|
16.5%
17/103 • Number of events 17 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
15.4%
8/52 • Number of events 8 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
17.0%
9/53 • Number of events 9 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
9.3%
8/86 • Number of events 8 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
16.7%
7/42 • Number of events 7 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
16.7%
7/42 • Number of events 7 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
15.5%
31/200 • Number of events 31 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
15.0%
15/100 • Number of events 15 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
17.0%
17/100 • Number of events 17 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
12.5%
25/200 • Number of events 25 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
6.0%
6/100 • Number of events 6 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
4.0%
4/99 • Number of events 4 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
|
Psychiatric disorders
Irritability
|
30.1%
31/103 • Number of events 31 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
23.1%
12/52 • Number of events 12 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
20.8%
11/53 • Number of events 11 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
16.3%
14/86 • Number of events 15 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
26.2%
11/42 • Number of events 11 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
33.3%
14/42 • Number of events 14 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
32.0%
64/200 • Number of events 64 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
34.0%
34/100 • Number of events 34 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
33.0%
33/100 • Number of events 33 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
13.0%
26/200 • Number of events 26 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
16.0%
16/100 • Number of events 16 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
9.1%
9/99 • Number of events 9 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.9%
3/103 • Number of events 3 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/52 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
9.4%
5/53 • Number of events 5 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/86 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/42 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/42 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
2.5%
5/200 • Number of events 5 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
3.0%
3/100 • Number of events 3 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
2.0%
2/100 • Number of events 2 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.50%
1/200 • Number of events 1 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
1.0%
1/100 • Number of events 1 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/99 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.97%
1/103 • Number of events 1 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
5.8%
3/52 • Number of events 3 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
7.5%
4/53 • Number of events 4 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/86 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/42 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/42 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.50%
1/200 • Number of events 1 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/100 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
1.0%
1/100 • Number of events 1 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/200 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/100 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
0.00%
0/99 • AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on SafAS. In the AE section, solicited reactions Fever, Abnormal crying, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
- Publication restrictions are in place
Restriction type: OTHER