Trial Outcomes & Findings for Immunogenicity and Safety Study of 1 and 2 Doses of GlaxoSmithKline (GSK) Biologicals' Meningococcal Vaccine MenACWY-TT (GSK134612) in Toddlers, Persistence up to 5 Years After Vaccination and Co-administration With Pfizer's Prevenar 13™Vaccine (NCT NCT01939158)
NCT ID: NCT01939158
Last Updated: 2021-10-05
Results Overview
Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). Percentage of participants with rSBA titers \>=1:8 against each serogroup at 1 month after administration of MenACWY-TT are reported. According-to-protocol (ATP) cohort for persistence Year 1 population included all participants who met all eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present with a medical condition or received product leading to exclusion or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
803 participants
Primary outcome timeframe
1 month after administration of 1st dose of MenACWY-TT (i.e. at Month 1)
Results posted on
2021-10-05
Participant Flow
Study was conducted from 2 October 2013 to 5 December 2019.
A total of 803 participants were enrolled and were randomized in 1:1:1:1 ratio to either ACWY1d, ACWY2d, Co-ad and PCV13 groups.
Participant milestones
| Measure |
ACWY1d Group
Participants received single dose of meningococcal polysaccharide groups A, C, W-135, and Y tetanus toxoid conjugate (MenACWY-TT) vaccine administered intramuscularly at Month 0.
|
ACWY2d Group
Participants received two doses of MenACWY-TT vaccine administered intramuscularly at Month 0 and Month 2.
|
Co-ad Group
Participants received single dose of MenACWY-TT vaccine and single dose of Prevnar 13 administered intramuscularly at Month 0.
|
PCV13 Group
Participants received single dose of Prevnar 13 at Month 0 and single dose of MenACWY-TT administered intramuscularly at Month 2.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
203
|
198
|
201
|
201
|
|
Overall Study
Vaccinated
|
203
|
197
|
201
|
201
|
|
Overall Study
COMPLETED
|
156
|
146
|
160
|
157
|
|
Overall Study
NOT COMPLETED
|
47
|
52
|
41
|
44
|
Reasons for withdrawal
| Measure |
ACWY1d Group
Participants received single dose of meningococcal polysaccharide groups A, C, W-135, and Y tetanus toxoid conjugate (MenACWY-TT) vaccine administered intramuscularly at Month 0.
|
ACWY2d Group
Participants received two doses of MenACWY-TT vaccine administered intramuscularly at Month 0 and Month 2.
|
Co-ad Group
Participants received single dose of MenACWY-TT vaccine and single dose of Prevnar 13 administered intramuscularly at Month 0.
|
PCV13 Group
Participants received single dose of Prevnar 13 at Month 0 and single dose of MenACWY-TT administered intramuscularly at Month 2.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
22
|
25
|
15
|
17
|
|
Overall Study
Migrated/moved from study area
|
5
|
7
|
3
|
6
|
|
Overall Study
Lost to Follow-up
|
18
|
17
|
17
|
17
|
|
Overall Study
Death
|
0
|
0
|
1
|
1
|
|
Overall Study
No longer meets eligibility criteria
|
0
|
0
|
1
|
0
|
|
Overall Study
Other
|
1
|
3
|
4
|
3
|
Baseline Characteristics
Immunogenicity and Safety Study of 1 and 2 Doses of GlaxoSmithKline (GSK) Biologicals' Meningococcal Vaccine MenACWY-TT (GSK134612) in Toddlers, Persistence up to 5 Years After Vaccination and Co-administration With Pfizer's Prevenar 13™Vaccine
Baseline characteristics by cohort
| Measure |
ACWY1d Group
n=203 Participants
Participants received single dose of meningococcal polysaccharide groups A, C, W-135, and Y tetanus toxoid conjugate (MenACWY-TT) vaccine administered intramuscularly at Month 0.
|
ACWY2d Group
n=197 Participants
Participants received two doses of MenACWY-TT vaccine administered intramuscularly at Month 0 and Month 2.
|
Co-ad Group
n=201 Participants
Participants received single dose of MenACWY-TT vaccine and single dose of Prevnar 13 administered intramuscularly at Month 0.
|
PCV13 Group
n=201 Participants
Participants received single dose of Prevnar 13 at Month 0 and single dose of MenACWY-TT administered intramuscularly at Month 2.
|
Total
n=802 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
12.8 Months
STANDARD_DEVIATION 0.9 • n=5 Participants
|
12.8 Months
STANDARD_DEVIATION 0.9 • n=7 Participants
|
12.8 Months
STANDARD_DEVIATION 0.9 • n=5 Participants
|
12.7 Months
STANDARD_DEVIATION 0.9 • n=4 Participants
|
12.8 Months
STANDARD_DEVIATION 0.9 • n=21 Participants
|
|
Sex: Female, Male
Female
|
94 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
98 Participants
n=4 Participants
|
375 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
109 Participants
n=5 Participants
|
112 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
103 Participants
n=4 Participants
|
427 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
31 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
195 Participants
n=5 Participants
|
189 Participants
n=7 Participants
|
194 Participants
n=5 Participants
|
193 Participants
n=4 Participants
|
771 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
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
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
33 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
127 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
135 Participants
n=5 Participants
|
127 Participants
n=7 Participants
|
137 Participants
n=5 Participants
|
134 Participants
n=4 Participants
|
533 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
34 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
130 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
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
|
PRIMARY outcome
Timeframe: 1 month after administration of 1st dose of MenACWY-TT (i.e. at Month 1)Population: Analyzed on ATP cohort for persistence Year 1 population. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure and 'number analyzed' signifies participants evaluable for each specified category. Data for this outcome measure was not planned to be collected and analyzed for PCV13 reporting group.
Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). Percentage of participants with rSBA titers \>=1:8 against each serogroup at 1 month after administration of MenACWY-TT are reported. According-to-protocol (ATP) cohort for persistence Year 1 population included all participants who met all eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present with a medical condition or received product leading to exclusion or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.
Outcome measures
| Measure |
ACWY1d Group
n=180 Participants
Participants received single dose of meningococcal polysaccharide groups A, C, W-135, and Y tetanus toxoid conjugate (MenACWY-TT) vaccine administered intramuscularly at Month 0.
|
ACWY2d Group
n=158 Participants
Participants received two doses of MenACWY-TT vaccine administered intramuscularly at Month 0 and Month 2.
|
Co-ad Group
n=178 Participants
Participants received single dose of MenACWY-TT vaccine and single dose of Prevnar 13 administered intramuscularly at Month 0.
|
PCV13 Group
Participants received single dose of Prevnar 13 at Month 0 and single dose of MenACWY-TT administered intramuscularly at Month 2.
|
|---|---|---|---|---|
|
Percentage of Participants With Serum Bactericidal Assay Using Rabbit Complement Antibody (rSBA) Titers >=1:8 at 1 Month After Administration of 1 Dose of MenACWY-TT in the ACWY1d, ACWY2d and Co-ad Groups
rSBA-MenA
|
97.8 percentage of participants
Interval 94.4 to 99.4
|
96.8 percentage of participants
Interval 92.8 to 99.0
|
94.9 percentage of participants
Interval 90.6 to 97.7
|
—
|
|
Percentage of Participants With Serum Bactericidal Assay Using Rabbit Complement Antibody (rSBA) Titers >=1:8 at 1 Month After Administration of 1 Dose of MenACWY-TT in the ACWY1d, ACWY2d and Co-ad Groups
rSBA-MenC
|
95.0 percentage of participants
Interval 90.7 to 97.7
|
95.5 percentage of participants
Interval 91.0 to 98.2
|
96.0 percentage of participants
Interval 92.0 to 98.4
|
—
|
|
Percentage of Participants With Serum Bactericidal Assay Using Rabbit Complement Antibody (rSBA) Titers >=1:8 at 1 Month After Administration of 1 Dose of MenACWY-TT in the ACWY1d, ACWY2d and Co-ad Groups
rSBA-MenW-135
|
95.0 percentage of participants
Interval 90.7 to 97.7
|
94.9 percentage of participants
Interval 90.3 to 97.8
|
93.2 percentage of participants
Interval 88.5 to 96.4
|
—
|
|
Percentage of Participants With Serum Bactericidal Assay Using Rabbit Complement Antibody (rSBA) Titers >=1:8 at 1 Month After Administration of 1 Dose of MenACWY-TT in the ACWY1d, ACWY2d and Co-ad Groups
rSBA-MenY
|
92.8 percentage of participants
Interval 88.0 to 96.1
|
93.6 percentage of participants
Interval 88.6 to 96.9
|
89.8 percentage of participants
Interval 84.4 to 93.9
|
—
|
PRIMARY outcome
Timeframe: 1 month after administration of 2nd dose of MenACWY-TT (i.e. at Month 3)Population: Analyzed on ATP cohort for persistence Year 1 population. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure. Data for this outcome measure was not planned to be collected and analyzed for ACWY1d, Co-ad and PCV13 reporting groups.
Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). Percentage of participants with rSBA titers \>=1:8 against each serogroup at 1 month after administration of 2 doses of MenACWY-TT are reported. ATP cohort for persistence Year 1 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.
Outcome measures
| Measure |
ACWY1d Group
n=150 Participants
Participants received single dose of meningococcal polysaccharide groups A, C, W-135, and Y tetanus toxoid conjugate (MenACWY-TT) vaccine administered intramuscularly at Month 0.
|
ACWY2d Group
Participants received two doses of MenACWY-TT vaccine administered intramuscularly at Month 0 and Month 2.
|
Co-ad Group
Participants received single dose of MenACWY-TT vaccine and single dose of Prevnar 13 administered intramuscularly at Month 0.
|
PCV13 Group
Participants received single dose of Prevnar 13 at Month 0 and single dose of MenACWY-TT administered intramuscularly at Month 2.
|
|---|---|---|---|---|
|
Percentage of Participants With rSBA Titers >=1:8 at 1 Month After Administration of 2 Doses of MenACWY-TT in the ACWY2d Group
rSBA-MenA
|
98.0 percentage of participants
Interval 94.3 to 99.6
|
—
|
—
|
—
|
|
Percentage of Participants With rSBA Titers >=1:8 at 1 Month After Administration of 2 Doses of MenACWY-TT in the ACWY2d Group
rSBA-MenC
|
98.7 percentage of participants
Interval 95.3 to 99.8
|
—
|
—
|
—
|
|
Percentage of Participants With rSBA Titers >=1:8 at 1 Month After Administration of 2 Doses of MenACWY-TT in the ACWY2d Group
rSBA-MenW-135
|
100.0 percentage of participants
Interval 97.6 to 100.0
|
—
|
—
|
—
|
|
Percentage of Participants With rSBA Titers >=1:8 at 1 Month After Administration of 2 Doses of MenACWY-TT in the ACWY2d Group
rSBA-MenY
|
99.3 percentage of participants
Interval 96.3 to 100.0
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Year 1Population: Analyzed on ATP cohort for persistence Year 1 population. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure. Data for this outcome measure was not planned to be collected and analyzed for Co-ad and PCV13 reporting groups.
Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). Percentage of participants with rSBA titers \>=1:8 and \>=1:128 against each serogroup at Year 1 after administration of MenACWY-TT are reported. ATP cohort for persistence Year 1 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.
Outcome measures
| Measure |
ACWY1d Group
n=167 Participants
Participants received single dose of meningococcal polysaccharide groups A, C, W-135, and Y tetanus toxoid conjugate (MenACWY-TT) vaccine administered intramuscularly at Month 0.
|
ACWY2d Group
n=143 Participants
Participants received two doses of MenACWY-TT vaccine administered intramuscularly at Month 0 and Month 2.
|
Co-ad Group
Participants received single dose of MenACWY-TT vaccine and single dose of Prevnar 13 administered intramuscularly at Month 0.
|
PCV13 Group
Participants received single dose of Prevnar 13 at Month 0 and single dose of MenACWY-TT administered intramuscularly at Month 2.
|
|---|---|---|---|---|
|
Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at Year 1 in the ACWY1d and ACWY2d Groups
rSBA-MenA: >=1:8
|
63.5 percentage of participants
Interval 55.7 to 70.8
|
70.6 percentage of participants
Interval 62.4 to 77.9
|
—
|
—
|
|
Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at Year 1 in the ACWY1d and ACWY2d Groups
rSBA-MenC: >=1:8
|
49.1 percentage of participants
Interval 41.3 to 56.9
|
55.2 percentage of participants
Interval 46.7 to 63.6
|
—
|
—
|
|
Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at Year 1 in the ACWY1d and ACWY2d Groups
rSBA-MenW-135: >=1:8
|
65.3 percentage of participants
Interval 57.5 to 72.5
|
77.6 percentage of participants
Interval 69.9 to 84.2
|
—
|
—
|
|
Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at Year 1 in the ACWY1d and ACWY2d Groups
rSBA-MenY: >=1:8
|
73.1 percentage of participants
Interval 65.7 to 79.6
|
79.7 percentage of participants
Interval 72.2 to 86.0
|
—
|
—
|
|
Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at Year 1 in the ACWY1d and ACWY2d Groups
rSBA-MenA: >=1:128
|
44.9 percentage of participants
Interval 37.2 to 52.8
|
50.3 percentage of participants
Interval 41.9 to 58.8
|
—
|
—
|
|
Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at Year 1 in the ACWY1d and ACWY2d Groups
rSBA-MenC: >=1:128
|
21.0 percentage of participants
Interval 15.1 to 27.9
|
27.3 percentage of participants
Interval 20.2 to 35.3
|
—
|
—
|
|
Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at Year 1 in the ACWY1d and ACWY2d Groups
rSBA-MenW-135: >=1:128
|
46.7 percentage of participants
Interval 39.0 to 54.6
|
60.1 percentage of participants
Interval 51.6 to 68.2
|
—
|
—
|
|
Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at Year 1 in the ACWY1d and ACWY2d Groups
rSBA-MenY: >=1:128
|
52.1 percentage of participants
Interval 44.2 to 59.9
|
60.8 percentage of participants
Interval 52.3 to 68.9
|
—
|
—
|
PRIMARY outcome
Timeframe: At Year 1Population: Analyzed on ATP cohort for persistence Year 1 population. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure. Data for this outcome measure was not planned to be collected and analyzed for Co-ad and PCV13 reporting groups.
Geometric mean titers of antibodies against each serogroup were assessed using rSBA. Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). rSBA titers are expressed as 1/dilution. ATP cohort for persistence Year 1 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.
Outcome measures
| Measure |
ACWY1d Group
n=167 Participants
Participants received single dose of meningococcal polysaccharide groups A, C, W-135, and Y tetanus toxoid conjugate (MenACWY-TT) vaccine administered intramuscularly at Month 0.
|
ACWY2d Group
n=143 Participants
Participants received two doses of MenACWY-TT vaccine administered intramuscularly at Month 0 and Month 2.
|
Co-ad Group
Participants received single dose of MenACWY-TT vaccine and single dose of Prevnar 13 administered intramuscularly at Month 0.
|
PCV13 Group
Participants received single dose of Prevnar 13 at Month 0 and single dose of MenACWY-TT administered intramuscularly at Month 2.
|
|---|---|---|---|---|
|
Geometric Mean Titers (GMTs) With rSBA for Each of the 4 Serogroups Following Vaccination at Year 1 in the ACWY1d and ACWY2d Groups
rSBA-MenA
|
62.7 titers (1/dilution)
Interval 42.6 to 92.2
|
76.6 titers (1/dilution)
Interval 50.7 to 115.7
|
—
|
—
|
|
Geometric Mean Titers (GMTs) With rSBA for Each of the 4 Serogroups Following Vaccination at Year 1 in the ACWY1d and ACWY2d Groups
rSBA-MenC
|
16.2 titers (1/dilution)
Interval 12.4 to 21.1
|
21.2 titers (1/dilution)
Interval 15.6 to 28.9
|
—
|
—
|
|
Geometric Mean Titers (GMTs) With rSBA for Each of the 4 Serogroups Following Vaccination at Year 1 in the ACWY1d and ACWY2d Groups
rSBA-MenW-135
|
57.2 titers (1/dilution)
Interval 39.9 to 82.0
|
123.1 titers (1/dilution)
Interval 82.7 to 183.4
|
—
|
—
|
|
Geometric Mean Titers (GMTs) With rSBA for Each of the 4 Serogroups Following Vaccination at Year 1 in the ACWY1d and ACWY2d Groups
rSBA-MenY
|
76.8 titers (1/dilution)
Interval 54.2 to 109.0
|
112.3 titers (1/dilution)
Interval 77.5 to 162.8
|
—
|
—
|
PRIMARY outcome
Timeframe: At Year 3Population: Analyzed on ATP cohort for persistence Year 3 population. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure. Data for this outcome measure was not planned to be collected and analyzed for Co-ad and PCV13 reporting groups.
Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). Percentage of participants with rSBA titers \>=1:8 and \>=1:128 against each serogroup at Year 3 after administration of MenACWY-TT are reported. ATP cohort for persistence Year 3 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.
Outcome measures
| Measure |
ACWY1d Group
n=147 Participants
Participants received single dose of meningococcal polysaccharide groups A, C, W-135, and Y tetanus toxoid conjugate (MenACWY-TT) vaccine administered intramuscularly at Month 0.
|
ACWY2d Group
n=121 Participants
Participants received two doses of MenACWY-TT vaccine administered intramuscularly at Month 0 and Month 2.
|
Co-ad Group
Participants received single dose of MenACWY-TT vaccine and single dose of Prevnar 13 administered intramuscularly at Month 0.
|
PCV13 Group
Participants received single dose of Prevnar 13 at Month 0 and single dose of MenACWY-TT administered intramuscularly at Month 2.
|
|---|---|---|---|---|
|
Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at Year 3 in the ACWY1d and ACWY2d Groups
rSBA-MenA: >=1:8
|
46.9 percentage of participants
Interval 38.7 to 55.3
|
54.5 percentage of participants
Interval 45.2 to 63.6
|
—
|
—
|
|
Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at Year 3 in the ACWY1d and ACWY2d Groups
rSBA-MenC: >=1:8
|
35.4 percentage of participants
Interval 27.7 to 43.7
|
33.9 percentage of participants
Interval 25.5 to 43.0
|
—
|
—
|
|
Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at Year 3 in the ACWY1d and ACWY2d Groups
rSBA-MenW-135: >=1:8
|
59.2 percentage of participants
Interval 50.8 to 67.2
|
72.7 percentage of participants
Interval 63.9 to 80.4
|
—
|
—
|
|
Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at Year 3 in the ACWY1d and ACWY2d Groups
rSBA-MenY: >=1:8
|
61.9 percentage of participants
Interval 53.5 to 69.8
|
68.6 percentage of participants
Interval 59.5 to 76.7
|
—
|
—
|
|
Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at Year 3 in the ACWY1d and ACWY2d Groups
rSBA-MenA: >=1:128
|
34.0 percentage of participants
Interval 26.4 to 42.3
|
31.4 percentage of participants
Interval 23.3 to 40.5
|
—
|
—
|
|
Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at Year 3 in the ACWY1d and ACWY2d Groups
rSBA-MenC: >=1:128
|
9.5 percentage of participants
Interval 5.3 to 15.5
|
15.7 percentage of participants
Interval 9.7 to 23.4
|
—
|
—
|
|
Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at Year 3 in the ACWY1d and ACWY2d Groups
rSBA-MenW-135: >=1:128
|
42.9 percentage of participants
Interval 34.7 to 51.3
|
52.9 percentage of participants
Interval 43.6 to 62.0
|
—
|
—
|
|
Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at Year 3 in the ACWY1d and ACWY2d Groups
rSBA-MenY: >=1:128
|
49.0 percentage of participants
Interval 40.7 to 57.3
|
53.7 percentage of participants
Interval 44.4 to 62.8
|
—
|
—
|
PRIMARY outcome
Timeframe: At Year 3Population: Analyzed on ATP cohort for persistence Year 3 population. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure. Data for this outcome measure was not planned to be collected and analyzed for Co-ad and PCV13 reporting groups.
Geometric mean titers of antibodies against each serogroup were assessed using rSBA. Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). rSBA titers are expressed as 1/dilution. ATP cohort for persistence Year 3 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.
Outcome measures
| Measure |
ACWY1d Group
n=147 Participants
Participants received single dose of meningococcal polysaccharide groups A, C, W-135, and Y tetanus toxoid conjugate (MenACWY-TT) vaccine administered intramuscularly at Month 0.
|
ACWY2d Group
n=121 Participants
Participants received two doses of MenACWY-TT vaccine administered intramuscularly at Month 0 and Month 2.
|
Co-ad Group
Participants received single dose of MenACWY-TT vaccine and single dose of Prevnar 13 administered intramuscularly at Month 0.
|
PCV13 Group
Participants received single dose of Prevnar 13 at Month 0 and single dose of MenACWY-TT administered intramuscularly at Month 2.
|
|---|---|---|---|---|
|
Geometric Mean Titers (GMTs) With rSBA for Each of the 4 Serogroups Following Vaccination at Year 3 in the ACWY1d and ACWY2d Groups
rSBA-MenA
|
29.7 titers (1/dilution)
Interval 19.8 to 44.5
|
28.5 titers (1/dilution)
Interval 18.7 to 43.6
|
—
|
—
|
|
Geometric Mean Titers (GMTs) With rSBA for Each of the 4 Serogroups Following Vaccination at Year 3 in the ACWY1d and ACWY2d Groups
rSBA-MenC
|
9.8 titers (1/dilution)
Interval 7.6 to 12.7
|
11.5 titers (1/dilution)
Interval 8.4 to 15.8
|
—
|
—
|
|
Geometric Mean Titers (GMTs) With rSBA for Each of the 4 Serogroups Following Vaccination at Year 3 in the ACWY1d and ACWY2d Groups
rSBA-MenW-135
|
42.5 titers (1/dilution)
Interval 29.2 to 61.8
|
92.9 titers (1/dilution)
Interval 59.9 to 143.9
|
—
|
—
|
|
Geometric Mean Titers (GMTs) With rSBA for Each of the 4 Serogroups Following Vaccination at Year 3 in the ACWY1d and ACWY2d Groups
rSBA-MenY
|
58.0 titers (1/dilution)
Interval 39.1 to 86.0
|
75.1 titers (1/dilution)
Interval 48.7 to 115.9
|
—
|
—
|
PRIMARY outcome
Timeframe: At Year 5Population: Analyzed on ATP cohort for persistence Year 5 population. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure and 'number analyzed' signifies participants evaluable for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Co-ad and PCV13 reporting groups.
Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). Percentage of participants with rSBA titers \>=1:8 and \>=1:128 against each serogroup at Year 5 after administration of MenACWY-TT are reported. ATP cohort for persistence Year 5 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.
Outcome measures
| Measure |
ACWY1d Group
n=133 Participants
Participants received single dose of meningococcal polysaccharide groups A, C, W-135, and Y tetanus toxoid conjugate (MenACWY-TT) vaccine administered intramuscularly at Month 0.
|
ACWY2d Group
n=117 Participants
Participants received two doses of MenACWY-TT vaccine administered intramuscularly at Month 0 and Month 2.
|
Co-ad Group
Participants received single dose of MenACWY-TT vaccine and single dose of Prevnar 13 administered intramuscularly at Month 0.
|
PCV13 Group
Participants received single dose of Prevnar 13 at Month 0 and single dose of MenACWY-TT administered intramuscularly at Month 2.
|
|---|---|---|---|---|
|
Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at Year 5 in the ACWY1d and ACWY2d Groups
rSBA-MenA: >=1:8
|
58.6 percentage of participants
Interval 49.8 to 67.1
|
65.8 percentage of participants
Interval 56.5 to 74.3
|
—
|
—
|
|
Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at Year 5 in the ACWY1d and ACWY2d Groups
rSBA-MenC: >=1:8
|
20.5 percentage of participants
Interval 13.9 to 28.3
|
28.4 percentage of participants
Interval 20.5 to 37.6
|
—
|
—
|
|
Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at Year 5 in the ACWY1d and ACWY2d Groups
rSBA-MenW-135: >=1:8
|
44.4 percentage of participants
Interval 35.8 to 53.2
|
50.4 percentage of participants
Interval 41.0 to 59.8
|
—
|
—
|
|
Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at Year 5 in the ACWY1d and ACWY2d Groups
rSBA-MenY: >=1:8
|
47.4 percentage of participants
Interval 38.7 to 56.2
|
58.1 percentage of participants
Interval 48.6 to 67.2
|
—
|
—
|
|
Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at Year 5 in the ACWY1d and ACWY2d Groups
rSBA-MenA: >=1:128
|
43.6 percentage of participants
Interval 35.0 to 52.5
|
53.0 percentage of participants
Interval 43.5 to 62.3
|
—
|
—
|
|
Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at Year 5 in the ACWY1d and ACWY2d Groups
rSBA-MenC: >=1:128
|
6.1 percentage of participants
Interval 2.7 to 11.6
|
10.3 percentage of participants
Interval 5.5 to 17.4
|
—
|
—
|
|
Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at Year 5 in the ACWY1d and ACWY2d Groups
rSBA-MenW-135: >=1:128
|
32.3 percentage of participants
Interval 24.5 to 41.0
|
39.3 percentage of participants
Interval 30.4 to 48.8
|
—
|
—
|
|
Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at Year 5 in the ACWY1d and ACWY2d Groups
rSBA-MenY: >=1:128
|
39.8 percentage of participants
Interval 31.5 to 48.7
|
52.1 percentage of participants
Interval 42.7 to 61.5
|
—
|
—
|
PRIMARY outcome
Timeframe: At Year 5Population: Analyzed on ATP cohort for persistence Year 5 population. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure and 'number analyzed' signifies participants evaluable for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Co-ad and PCV13 reporting groups.
Geometric mean titers of antibodies against each serogroup were assessed using rSBA. Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). rSBA titers are expressed as 1/dilution. ATP cohort for persistence Year 5 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.
Outcome measures
| Measure |
ACWY1d Group
n=133 Participants
Participants received single dose of meningococcal polysaccharide groups A, C, W-135, and Y tetanus toxoid conjugate (MenACWY-TT) vaccine administered intramuscularly at Month 0.
|
ACWY2d Group
n=117 Participants
Participants received two doses of MenACWY-TT vaccine administered intramuscularly at Month 0 and Month 2.
|
Co-ad Group
Participants received single dose of MenACWY-TT vaccine and single dose of Prevnar 13 administered intramuscularly at Month 0.
|
PCV13 Group
Participants received single dose of Prevnar 13 at Month 0 and single dose of MenACWY-TT administered intramuscularly at Month 2.
|
|---|---|---|---|---|
|
Geometric Mean Titers (GMTs) With rSBA for Each of the 4 Serogroups Following Vaccination at Year 5 in the ACWY1d and ACWY2d Groups
rSBA-MenA
|
46.8 titers (1/dilution)
Interval 30.7 to 71.5
|
69.9 titers (1/dilution)
Interval 44.7 to 109.3
|
—
|
—
|
|
Geometric Mean Titers (GMTs) With rSBA for Each of the 4 Serogroups Following Vaccination at Year 5 in the ACWY1d and ACWY2d Groups
rSBA-MenC
|
6.6 titers (1/dilution)
Interval 5.3 to 8.2
|
8.5 titers (1/dilution)
Interval 6.4 to 11.2
|
—
|
—
|
|
Geometric Mean Titers (GMTs) With rSBA for Each of the 4 Serogroups Following Vaccination at Year 5 in the ACWY1d and ACWY2d Groups
rSBA-MenW-135
|
25.0 titers (1/dilution)
Interval 16.7 to 37.6
|
37.1 titers (1/dilution)
Interval 23.3 to 59.0
|
—
|
—
|
|
Geometric Mean Titers (GMTs) With rSBA for Each of the 4 Serogroups Following Vaccination at Year 5 in the ACWY1d and ACWY2d Groups
rSBA-MenY
|
36.5 titers (1/dilution)
Interval 23.6 to 56.2
|
55.8 titers (1/dilution)
Interval 35.7 to 87.5
|
—
|
—
|
PRIMARY outcome
Timeframe: 1 month after administration of Prevnar 13 (i.e. at Month 1)Population: Analyzed on ATP cohort for immunogenicity post dose 1 population. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure and 'number analyzed' signifies participants evaluable for each specified category. Data for this outcome measure was not planned to be collected and analyzed for ACWY1d and ACWY2d reporting groups.
GMCs for anti-pneumococcal antibodies (anti-1, anti-3, anti-4, anti-5, anti-6A, anti-6B, anti-7F, anti-9V, anti-14, anti-18C, anti-19A, anti-19F and anti-23F) were measured in microgram per milliliter (mcg/mL). ATP cohort for immunogenicity post dose 1 included all evaluable participants who met eligibility criteria, complied with the procedures defined in the protocol and with no elimination criteria during the study from the ATP cohort for safety, received all study vaccines at Month 0, had assay results available for antibodies against at least one study vaccine antigen component at Visit 2 (Month 1), and had available blood sample at Visit 2 (Month 1) for PCV13 group.
Outcome measures
| Measure |
ACWY1d Group
n=163 Participants
Participants received single dose of meningococcal polysaccharide groups A, C, W-135, and Y tetanus toxoid conjugate (MenACWY-TT) vaccine administered intramuscularly at Month 0.
|
ACWY2d Group
n=172 Participants
Participants received two doses of MenACWY-TT vaccine administered intramuscularly at Month 0 and Month 2.
|
Co-ad Group
Participants received single dose of MenACWY-TT vaccine and single dose of Prevnar 13 administered intramuscularly at Month 0.
|
PCV13 Group
Participants received single dose of Prevnar 13 at Month 0 and single dose of MenACWY-TT administered intramuscularly at Month 2.
|
|---|---|---|---|---|
|
Geometric Mean Concentrations (GMCs) of Antibodies for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups
anti-1
|
2.94 mcg/mL
Interval 2.56 to 3.36
|
2.62 mcg/mL
Interval 2.27 to 3.01
|
—
|
—
|
|
Geometric Mean Concentrations (GMCs) of Antibodies for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups
anti-3
|
0.80 mcg/mL
Interval 0.69 to 0.91
|
0.71 mcg/mL
Interval 0.62 to 0.81
|
—
|
—
|
|
Geometric Mean Concentrations (GMCs) of Antibodies for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups
anti-4
|
2.46 mcg/mL
Interval 2.14 to 2.83
|
1.96 mcg/mL
Interval 1.69 to 2.26
|
—
|
—
|
|
Geometric Mean Concentrations (GMCs) of Antibodies for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups
anti-5
|
2.09 mcg/mL
Interval 1.84 to 2.37
|
1.67 mcg/mL
Interval 1.46 to 1.91
|
—
|
—
|
|
Geometric Mean Concentrations (GMCs) of Antibodies for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups
anti-6A
|
8.59 mcg/mL
Interval 7.5 to 9.85
|
7.28 mcg/mL
Interval 6.33 to 8.37
|
—
|
—
|
|
Geometric Mean Concentrations (GMCs) of Antibodies for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups
anti-6B
|
7.36 mcg/mL
Interval 6.33 to 8.55
|
6.68 mcg/mL
Interval 5.7 to 7.83
|
—
|
—
|
|
Geometric Mean Concentrations (GMCs) of Antibodies for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups
anti-7F
|
5.14 mcg/mL
Interval 4.49 to 5.88
|
4.81 mcg/mL
Interval 4.23 to 5.47
|
—
|
—
|
|
Geometric Mean Concentrations (GMCs) of Antibodies for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups
anti-9V
|
2.03 mcg/mL
Interval 1.78 to 2.3
|
1.79 mcg/mL
Interval 1.59 to 2.03
|
—
|
—
|
|
Geometric Mean Concentrations (GMCs) of Antibodies for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups
anti-14
|
13.1 mcg/mL
Interval 11.38 to 15.07
|
11.94 mcg/mL
Interval 10.43 to 13.66
|
—
|
—
|
|
Geometric Mean Concentrations (GMCs) of Antibodies for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups
anti-18C
|
2.53 mcg/mL
Interval 2.19 to 2.92
|
2.13 mcg/mL
Interval 1.84 to 2.47
|
—
|
—
|
|
Geometric Mean Concentrations (GMCs) of Antibodies for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups
anti-19A
|
9.60 mcg/mL
Interval 8.41 to 10.97
|
8.62 mcg/mL
Interval 7.53 to 9.87
|
—
|
—
|
|
Geometric Mean Concentrations (GMCs) of Antibodies for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups
anti-19F
|
8.40 mcg/mL
Interval 7.33 to 9.62
|
7.98 mcg/mL
Interval 6.96 to 9.15
|
—
|
—
|
|
Geometric Mean Concentrations (GMCs) of Antibodies for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups
anti-23F
|
5.33 mcg/mL
Interval 4.57 to 6.21
|
4.47 mcg/mL
Interval 3.83 to 5.23
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 month after administration of 1st dose of MenACWY-TT (i.e. at Month 1)Population: Analyzed on ATP cohort for persistence Year 1 population. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure and 'number analyzed' signifies participants evaluable for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Co-ad and PCV13 reporting groups.
Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). Percentage of participants with hSBA titers \>=1:4 and \>=1:8 against each serogroup at 1 month after administration of MenACWY-TT are reported. ATP cohort for persistence Year 1 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.
Outcome measures
| Measure |
ACWY1d Group
n=78 Participants
Participants received single dose of meningococcal polysaccharide groups A, C, W-135, and Y tetanus toxoid conjugate (MenACWY-TT) vaccine administered intramuscularly at Month 0.
|
ACWY2d Group
n=70 Participants
Participants received two doses of MenACWY-TT vaccine administered intramuscularly at Month 0 and Month 2.
|
Co-ad Group
Participants received single dose of MenACWY-TT vaccine and single dose of Prevnar 13 administered intramuscularly at Month 0.
|
PCV13 Group
Participants received single dose of Prevnar 13 at Month 0 and single dose of MenACWY-TT administered intramuscularly at Month 2.
|
|---|---|---|---|---|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titers >=1:4 and >=1:8 at 1 Month After Administration of 1 Dose of MenACWY-TT in the ACWY1d and ACWY2d Groups
hSBA-MenA: >=1:4
|
95.9 percentage of participants
Interval 88.6 to 99.2
|
97.0 percentage of participants
Interval 89.5 to 99.6
|
—
|
—
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titers >=1:4 and >=1:8 at 1 Month After Administration of 1 Dose of MenACWY-TT in the ACWY1d and ACWY2d Groups
hSBA-MenC: >=1:4
|
98.7 percentage of participants
Interval 93.1 to 100.0
|
97.1 percentage of participants
Interval 90.1 to 99.7
|
—
|
—
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titers >=1:4 and >=1:8 at 1 Month After Administration of 1 Dose of MenACWY-TT in the ACWY1d and ACWY2d Groups
hSBA-MenW-135: >=1:4
|
62.5 percentage of participants
Interval 50.3 to 73.6
|
68.9 percentage of participants
Interval 55.7 to 80.1
|
—
|
—
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titers >=1:4 and >=1:8 at 1 Month After Administration of 1 Dose of MenACWY-TT in the ACWY1d and ACWY2d Groups
hSBA-MenY: >=1:4
|
67.6 percentage of participants
Interval 55.5 to 78.2
|
64.3 percentage of participants
Interval 50.4 to 76.6
|
—
|
—
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titers >=1:4 and >=1:8 at 1 Month After Administration of 1 Dose of MenACWY-TT in the ACWY1d and ACWY2d Groups
hSBA-MenA: >=1:8
|
95.9 percentage of participants
Interval 88.6 to 99.2
|
97.0 percentage of participants
Interval 89.5 to 99.6
|
—
|
—
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titers >=1:4 and >=1:8 at 1 Month After Administration of 1 Dose of MenACWY-TT in the ACWY1d and ACWY2d Groups
hSBA-MenC: >=1:8
|
98.7 percentage of participants
Interval 93.1 to 100.0
|
95.7 percentage of participants
Interval 88.0 to 99.1
|
—
|
—
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titers >=1:4 and >=1:8 at 1 Month After Administration of 1 Dose of MenACWY-TT in the ACWY1d and ACWY2d Groups
hSBA-MenW-135: >=1:8
|
62.5 percentage of participants
Interval 50.3 to 73.6
|
68.9 percentage of participants
Interval 55.7 to 80.1
|
—
|
—
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titers >=1:4 and >=1:8 at 1 Month After Administration of 1 Dose of MenACWY-TT in the ACWY1d and ACWY2d Groups
hSBA-MenY: >=1:8
|
67.6 percentage of participants
Interval 55.5 to 78.2
|
64.3 percentage of participants
Interval 50.4 to 76.6
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 month after administration of 2nd dose of MenACWY-TT (i.e. at Month 3)Population: Analyzed on ATP cohort for persistence Year 1 population. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure and 'number analyzed' signifies participants evaluable for each specified category. Data for this outcome measure was not planned to be collected and analyzed for ACWY1d, Co-ad and PCV13 reporting groups.
Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). Percentage of participants with hSBA titers \>=1:4 and \>=1:8 against each serogroup at 1 month after administration of 2 doses of MenACWY-TT are reported. ATP cohort for persistence Year 1 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.
Outcome measures
| Measure |
ACWY1d Group
n=70 Participants
Participants received single dose of meningococcal polysaccharide groups A, C, W-135, and Y tetanus toxoid conjugate (MenACWY-TT) vaccine administered intramuscularly at Month 0.
|
ACWY2d Group
Participants received two doses of MenACWY-TT vaccine administered intramuscularly at Month 0 and Month 2.
|
Co-ad Group
Participants received single dose of MenACWY-TT vaccine and single dose of Prevnar 13 administered intramuscularly at Month 0.
|
PCV13 Group
Participants received single dose of Prevnar 13 at Month 0 and single dose of MenACWY-TT administered intramuscularly at Month 2.
|
|---|---|---|---|---|
|
Percentage of Participants With hSBA Titers >=1:4 and >=1:8 at 1 Month After Administration of 2 Doses of MenACWY-TT in the ACWY2d Group
hSBA-MenA: >=1:8
|
97.0 percentage of participants
Interval 89.5 to 99.6
|
—
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4 and >=1:8 at 1 Month After Administration of 2 Doses of MenACWY-TT in the ACWY2d Group
hSBA-MenW-135: >=1:4
|
97.1 percentage of participants
Interval 90.1 to 99.7
|
—
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4 and >=1:8 at 1 Month After Administration of 2 Doses of MenACWY-TT in the ACWY2d Group
hSBA-MenY: >=1:4
|
95.3 percentage of participants
Interval 86.9 to 99.0
|
—
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4 and >=1:8 at 1 Month After Administration of 2 Doses of MenACWY-TT in the ACWY2d Group
hSBA-MenA: >=1:4
|
97.0 percentage of participants
Interval 89.5 to 99.6
|
—
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4 and >=1:8 at 1 Month After Administration of 2 Doses of MenACWY-TT in the ACWY2d Group
hSBA-MenC: >=1:4
|
100.0 percentage of participants
Interval 94.8 to 100.0
|
—
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4 and >=1:8 at 1 Month After Administration of 2 Doses of MenACWY-TT in the ACWY2d Group
hSBA-MenC: >=1:8
|
100.0 percentage of participants
Interval 94.8 to 100.0
|
—
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4 and >=1:8 at 1 Month After Administration of 2 Doses of MenACWY-TT in the ACWY2d Group
hSBA-MenW-135: >=1:8
|
97.1 percentage of participants
Interval 90.1 to 99.7
|
—
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4 and >=1:8 at 1 Month After Administration of 2 Doses of MenACWY-TT in the ACWY2d Group
hSBA-MenY: >=1:8
|
95.3 percentage of participants
Interval 86.9 to 99.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 month after administration of 1st dose of MenACWY-TT (i.e. at Month 1)Population: Analyzed on ATP cohort for persistence Year 1 population. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure and 'number analyzed' signifies participants evaluable for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Co-ad and PCV13 reporting groups.
Geometric mean titers of antibodies against each serogroup were assessed using hSBA. Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). hSBA titers are expressed as 1/dilution. ATP cohort for persistence Year 1 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.
Outcome measures
| Measure |
ACWY1d Group
n=78 Participants
Participants received single dose of meningococcal polysaccharide groups A, C, W-135, and Y tetanus toxoid conjugate (MenACWY-TT) vaccine administered intramuscularly at Month 0.
|
ACWY2d Group
n=70 Participants
Participants received two doses of MenACWY-TT vaccine administered intramuscularly at Month 0 and Month 2.
|
Co-ad Group
Participants received single dose of MenACWY-TT vaccine and single dose of Prevnar 13 administered intramuscularly at Month 0.
|
PCV13 Group
Participants received single dose of Prevnar 13 at Month 0 and single dose of MenACWY-TT administered intramuscularly at Month 2.
|
|---|---|---|---|---|
|
Geometric Mean Titers (GMTs) With hSBA for Each of the 4 Serogroups Following Vaccination at 1 Month After Administration of 1 Dose of MenACWY-TT in the ACWY1d and ACWY2d Groups
hSBA-MenA
|
118.0 titers (1/dilution)
Interval 86.8 to 160.5
|
132.9 titers (1/dilution)
Interval 98.1 to 180.1
|
—
|
—
|
|
Geometric Mean Titers (GMTs) With hSBA for Each of the 4 Serogroups Following Vaccination at 1 Month After Administration of 1 Dose of MenACWY-TT in the ACWY1d and ACWY2d Groups
hSBA-MenC
|
151.9 titers (1/dilution)
Interval 104.8 to 220.4
|
160.8 titers (1/dilution)
Interval 109.8 to 235.5
|
—
|
—
|
|
Geometric Mean Titers (GMTs) With hSBA for Each of the 4 Serogroups Following Vaccination at 1 Month After Administration of 1 Dose of MenACWY-TT in the ACWY1d and ACWY2d Groups
hSBA-MenW-135
|
27.5 titers (1/dilution)
Interval 16.1 to 46.8
|
26.2 titers (1/dilution)
Interval 16.0 to 43.0
|
—
|
—
|
|
Geometric Mean Titers (GMTs) With hSBA for Each of the 4 Serogroups Following Vaccination at 1 Month After Administration of 1 Dose of MenACWY-TT in the ACWY1d and ACWY2d Groups
hSBA-MenY
|
41.2 titers (1/dilution)
Interval 23.7 to 71.5
|
31.9 titers (1/dilution)
Interval 17.6 to 57.9
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 month after administration of 2nd dose of MenACWY-TT (i.e. at Month 3)Population: Analyzed on ATP cohort for persistence Year 1 population. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure and 'number analyzed' signifies participants evaluable for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Co-ad and PCV13 reporting groups.
Geometric mean titers of antibodies against each serogroup were assessed using hSBA. Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). hSBA titers are expressed as 1/dilution. ATP cohort for persistence Year 1 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.
Outcome measures
| Measure |
ACWY1d Group
n=70 Participants
Participants received single dose of meningococcal polysaccharide groups A, C, W-135, and Y tetanus toxoid conjugate (MenACWY-TT) vaccine administered intramuscularly at Month 0.
|
ACWY2d Group
Participants received two doses of MenACWY-TT vaccine administered intramuscularly at Month 0 and Month 2.
|
Co-ad Group
Participants received single dose of MenACWY-TT vaccine and single dose of Prevnar 13 administered intramuscularly at Month 0.
|
PCV13 Group
Participants received single dose of Prevnar 13 at Month 0 and single dose of MenACWY-TT administered intramuscularly at Month 2.
|
|---|---|---|---|---|
|
Geometric Mean Titers (GMTs) With hSBA for Each of the 4 Serogroups Following Vaccination at 1 Month After Administration of 2 Doses of MenACWY-TT in the ACWY2d Group
hSBA-MenA
|
170.5 titers (1/dilution)
Interval 126.2 to 230.2
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) With hSBA for Each of the 4 Serogroups Following Vaccination at 1 Month After Administration of 2 Doses of MenACWY-TT in the ACWY2d Group
hSBA-MenC
|
1753.3 titers (1/dilution)
Interval 1278.7 to 2404.2
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) With hSBA for Each of the 4 Serogroups Following Vaccination at 1 Month After Administration of 2 Doses of MenACWY-TT in the ACWY2d Group
hSBA-MenW-135
|
756.8 titers (1/dilution)
Interval 550.1 to 1041.3
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) With hSBA for Each of the 4 Serogroups Following Vaccination at 1 Month After Administration of 2 Doses of MenACWY-TT in the ACWY2d Group
hSBA-MenY
|
513.0 titers (1/dilution)
Interval 339.4 to 775.4
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 month after administration of 1st dose of MenACWY-TT (i.e. at Month 3)Population: Analyzed on ATP cohort for persistence Year 1 population. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure. Data for this outcome measure was not planned to be collected and analyzed for ACWY1d, ACWY2d and Co-ad reporting groups.
Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). Percentage of participants with rSBA titers \>=1:8 and \>=1:128 against each serogroup at 1 month after administration of MenACWY-TT are reported. ATP cohort for persistence Year 1 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.
Outcome measures
| Measure |
ACWY1d Group
n=169 Participants
Participants received single dose of meningococcal polysaccharide groups A, C, W-135, and Y tetanus toxoid conjugate (MenACWY-TT) vaccine administered intramuscularly at Month 0.
|
ACWY2d Group
Participants received two doses of MenACWY-TT vaccine administered intramuscularly at Month 0 and Month 2.
|
Co-ad Group
Participants received single dose of MenACWY-TT vaccine and single dose of Prevnar 13 administered intramuscularly at Month 0.
|
PCV13 Group
Participants received single dose of Prevnar 13 at Month 0 and single dose of MenACWY-TT administered intramuscularly at Month 2.
|
|---|---|---|---|---|
|
Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at 1 Month After Administration of 1 Dose of MenACWY-TT in the PCV-13 Group
rSBA-MenA: >=1:8
|
96.4 percentage of participants
Interval 92.4 to 98.7
|
—
|
—
|
—
|
|
Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at 1 Month After Administration of 1 Dose of MenACWY-TT in the PCV-13 Group
rSBA-MenC: >=1:8
|
95.3 percentage of participants
Interval 90.9 to 97.9
|
—
|
—
|
—
|
|
Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at 1 Month After Administration of 1 Dose of MenACWY-TT in the PCV-13 Group
rSBA-MenW-135: >=1:8
|
96.4 percentage of participants
Interval 92.4 to 98.7
|
—
|
—
|
—
|
|
Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at 1 Month After Administration of 1 Dose of MenACWY-TT in the PCV-13 Group
rSBA-MenY: >=1:8
|
97.0 percentage of participants
Interval 93.2 to 99.0
|
—
|
—
|
—
|
|
Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at 1 Month After Administration of 1 Dose of MenACWY-TT in the PCV-13 Group
rSBA-MenA: >=1:128
|
95.9 percentage of participants
Interval 91.7 to 98.3
|
—
|
—
|
—
|
|
Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at 1 Month After Administration of 1 Dose of MenACWY-TT in the PCV-13 Group
rSBA-MenC: >=1:128
|
85.8 percentage of participants
Interval 79.6 to 90.7
|
—
|
—
|
—
|
|
Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at 1 Month After Administration of 1 Dose of MenACWY-TT in the PCV-13 Group
rSBA-MenW-135: >=1:128
|
96.4 percentage of participants
Interval 92.4 to 98.7
|
—
|
—
|
—
|
|
Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at 1 Month After Administration of 1 Dose of MenACWY-TT in the PCV-13 Group
rSBA-MenY: >=1:128
|
97.0 percentage of participants
Interval 93.2 to 99.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 month after administration of 1st dose of MenACWY-TT (i.e. at Month 3)Population: Analyzed on ATP cohort for persistence Year 1 population. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure. Data for this outcome measure was not planned to be collected and analyzed for ACWY1d, ACWY2d and Co-ad reporting groups.
Geometric mean titers of antibodies against each serogroup were assessed using rSBA. Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). rSBA titers are expressed as 1/dilution. ATP cohort for persistence Year 1 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.
Outcome measures
| Measure |
ACWY1d Group
n=169 Participants
Participants received single dose of meningococcal polysaccharide groups A, C, W-135, and Y tetanus toxoid conjugate (MenACWY-TT) vaccine administered intramuscularly at Month 0.
|
ACWY2d Group
Participants received two doses of MenACWY-TT vaccine administered intramuscularly at Month 0 and Month 2.
|
Co-ad Group
Participants received single dose of MenACWY-TT vaccine and single dose of Prevnar 13 administered intramuscularly at Month 0.
|
PCV13 Group
Participants received single dose of Prevnar 13 at Month 0 and single dose of MenACWY-TT administered intramuscularly at Month 2.
|
|---|---|---|---|---|
|
Geometric Mean Titers (GMTs) With rSBA Titers for Each of the 4 Serogroups Following Vaccination at 1 Month After Administration of 1 Dose of MenACWY-TT in the PCV-13 Group
rSBA-MenA
|
1957.7 titers (1/dilution)
Interval 1513.4 to 2532.3
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) With rSBA Titers for Each of the 4 Serogroups Following Vaccination at 1 Month After Administration of 1 Dose of MenACWY-TT in the PCV-13 Group
rSBA-MenC
|
376.4 titers (1/dilution)
Interval 284.7 to 497.6
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) With rSBA Titers for Each of the 4 Serogroups Following Vaccination at 1 Month After Administration of 1 Dose of MenACWY-TT in the PCV-13 Group
rSBA-MenW-135
|
3490.5 titers (1/dilution)
Interval 2643.3 to 4609.3
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) With rSBA Titers for Each of the 4 Serogroups Following Vaccination at 1 Month After Administration of 1 Dose of MenACWY-TT in the PCV-13 Group
rSBA-MenY
|
1481.2 titers (1/dilution)
Interval 1158.4 to 1893.9
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 month after administration of 1st dose of MenACWY-TT (i.e. at Month 1)Population: Analyzed on ATP cohort for persistence Year 1 population. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure and 'number analyzed' signifies participants evaluable for each specified category. Data for this outcome measure was not planned to be collected and analyzed for PCV13 reporting group.
Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). Percentage of participants with rSBA titers \>=1:128 against each serogroup at 1 month after administration of MenACWY-TT are reported. ATP cohort for persistence Year 1 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.
Outcome measures
| Measure |
ACWY1d Group
n=180 Participants
Participants received single dose of meningococcal polysaccharide groups A, C, W-135, and Y tetanus toxoid conjugate (MenACWY-TT) vaccine administered intramuscularly at Month 0.
|
ACWY2d Group
n=158 Participants
Participants received two doses of MenACWY-TT vaccine administered intramuscularly at Month 0 and Month 2.
|
Co-ad Group
n=178 Participants
Participants received single dose of MenACWY-TT vaccine and single dose of Prevnar 13 administered intramuscularly at Month 0.
|
PCV13 Group
Participants received single dose of Prevnar 13 at Month 0 and single dose of MenACWY-TT administered intramuscularly at Month 2.
|
|---|---|---|---|---|
|
Percentage of Participants With rSBA Titers >=1:128 at 1 Month After Administration of 1 Dose of MenACWY-TT in the ACWY1d, ACWY2d and Co-ad Groups
rSBA-MenA
|
94.4 percentage of participants
Interval 90.0 to 97.3
|
95.6 percentage of participants
Interval 91.1 to 98.2
|
93.8 percentage of participants
Interval 89.2 to 96.9
|
—
|
|
Percentage of Participants With rSBA Titers >=1:128 at 1 Month After Administration of 1 Dose of MenACWY-TT in the ACWY1d, ACWY2d and Co-ad Groups
rSBA-MenC
|
85.5 percentage of participants
Interval 79.4 to 90.3
|
85.4 percentage of participants
Interval 78.8 to 90.5
|
88.1 percentage of participants
Interval 82.3 to 92.5
|
—
|
|
Percentage of Participants With rSBA Titers >=1:128 at 1 Month After Administration of 1 Dose of MenACWY-TT in the ACWY1d, ACWY2d and Co-ad Groups
rSBA-MenW-135
|
95.0 percentage of participants
Interval 90.7 to 97.7
|
94.3 percentage of participants
Interval 89.5 to 97.4
|
92.7 percentage of participants
Interval 87.8 to 96.0
|
—
|
|
Percentage of Participants With rSBA Titers >=1:128 at 1 Month After Administration of 1 Dose of MenACWY-TT in the ACWY1d, ACWY2d and Co-ad Groups
rSBA-MenY
|
90.6 percentage of participants
Interval 85.3 to 94.4
|
91.7 percentage of participants
Interval 86.3 to 95.5
|
89.3 percentage of participants
Interval 83.7 to 93.4
|
—
|
SECONDARY outcome
Timeframe: 1 month after administration of 1st dose of MenACWY-TT (i.e. at Month 1)Population: Analyzed on ATP cohort for persistence Year 1 population. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure and 'number analyzed' signifies participants evaluable for each specified category. Data for this outcome measure was not planned to be collected and analyzed for PCV13 reporting group.
Geometric mean titers of antibodies against each serogroup were assessed using rSBA. Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). rSBA titers are expressed as 1/dilution. ATP cohort for persistence Year 1 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.
Outcome measures
| Measure |
ACWY1d Group
n=180 Participants
Participants received single dose of meningococcal polysaccharide groups A, C, W-135, and Y tetanus toxoid conjugate (MenACWY-TT) vaccine administered intramuscularly at Month 0.
|
ACWY2d Group
n=158 Participants
Participants received two doses of MenACWY-TT vaccine administered intramuscularly at Month 0 and Month 2.
|
Co-ad Group
n=178 Participants
Participants received single dose of MenACWY-TT vaccine and single dose of Prevnar 13 administered intramuscularly at Month 0.
|
PCV13 Group
Participants received single dose of Prevnar 13 at Month 0 and single dose of MenACWY-TT administered intramuscularly at Month 2.
|
|---|---|---|---|---|
|
Geometric Mean Titers (GMTs) With rSBA for Each of the 4 Serogroups Following Vaccination at 1 Month After Administration of 1 Dose of MenACWY-TT in ACWY1d, ACWY2d and Co-ad Groups
rSBA-MenA
|
1437.0 titers (1/dilution)
Interval 1118.3 to 1846.6
|
1275.2 titers (1/dilution)
Interval 970.5 to 1675.4
|
1146.4 titers (1/dilution)
Interval 867.9 to 1514.3
|
—
|
|
Geometric Mean Titers (GMTs) With rSBA for Each of the 4 Serogroups Following Vaccination at 1 Month After Administration of 1 Dose of MenACWY-TT in ACWY1d, ACWY2d and Co-ad Groups
rSBA-MenC
|
452.3 titers (1/dilution)
Interval 345.6 to 591.9
|
369.3 titers (1/dilution)
Interval 280.9 to 485.5
|
337.3 titers (1/dilution)
Interval 263.8 to 431.1
|
—
|
|
Geometric Mean Titers (GMTs) With rSBA for Each of the 4 Serogroups Following Vaccination at 1 Month After Administration of 1 Dose of MenACWY-TT in ACWY1d, ACWY2d and Co-ad Groups
rSBA-MenW-135
|
2120.2 titers (1/dilution)
Interval 1601.0 to 2807.8
|
2030.1 titers (1/dilution)
Interval 1510.7 to 2728.2
|
1550.9 titers (1/dilution)
Interval 1137.4 to 2114.7
|
—
|
|
Geometric Mean Titers (GMTs) With rSBA for Each of the 4 Serogroups Following Vaccination at 1 Month After Administration of 1 Dose of MenACWY-TT in ACWY1d, ACWY2d and Co-ad Groups
rSBA-MenY
|
951.8 titers (1/dilution)
Interval 705.0 to 1284.9
|
933.3 titers (1/dilution)
Interval 692.3 to 1258.3
|
778.5 titers (1/dilution)
Interval 566.2 to 1070.4
|
—
|
SECONDARY outcome
Timeframe: At Year 1, Year 3, Year 5Population: Analyzed on ATP cohort for persistence Year 1, 3 and 5 population. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure and 'number analyzed' signifies participants evaluable for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Co-ad and PCV13 reporting groups.
Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). Percentage of participants with hSBA titers \>=1:4 and \>=1:8 against each serogroup at Year 1, 3 and 5 after administration of MenACWY-TT are reported. ATP cohort for persistence Year 1, 3 and 5 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.
Outcome measures
| Measure |
ACWY1d Group
n=72 Participants
Participants received single dose of meningococcal polysaccharide groups A, C, W-135, and Y tetanus toxoid conjugate (MenACWY-TT) vaccine administered intramuscularly at Month 0.
|
ACWY2d Group
n=65 Participants
Participants received two doses of MenACWY-TT vaccine administered intramuscularly at Month 0 and Month 2.
|
Co-ad Group
Participants received single dose of MenACWY-TT vaccine and single dose of Prevnar 13 administered intramuscularly at Month 0.
|
PCV13 Group
Participants received single dose of Prevnar 13 at Month 0 and single dose of MenACWY-TT administered intramuscularly at Month 2.
|
|---|---|---|---|---|
|
Percentage of Participants With hSBA Titers >=1:4 and >=1:8 at Year 1, 3 and 5 in the ACWY1d and ACWY2d Groups
hSBA-MenA: >=1:4 (Year 1)
|
37.1 percentage of participants
Interval 25.9 to 49.5
|
35.5 percentage of participants
Interval 23.7 to 48.7
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4 and >=1:8 at Year 1, 3 and 5 in the ACWY1d and ACWY2d Groups
hSBA-MenC: >=1:4 (Year 1)
|
81.7 percentage of participants
Interval 70.7 to 89.9
|
93.7 percentage of participants
Interval 84.5 to 98.2
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4 and >=1:8 at Year 1, 3 and 5 in the ACWY1d and ACWY2d Groups
hSBA-MenW-135: >=1:4 (Year 1)
|
95.8 percentage of participants
Interval 88.3 to 99.1
|
98.5 percentage of participants
Interval 91.7 to 100.0
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4 and >=1:8 at Year 1, 3 and 5 in the ACWY1d and ACWY2d Groups
hSBA-MenY: >=1:4 (Year 1)
|
91.9 percentage of participants
Interval 82.2 to 97.3
|
87.9 percentage of participants
Interval 76.7 to 95.0
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4 and >=1:8 at Year 1, 3 and 5 in the ACWY1d and ACWY2d Groups
hSBA-MenA: >=1:8 (Year 1)
|
35.7 percentage of participants
Interval 24.6 to 48.1
|
35.5 percentage of participants
Interval 23.7 to 48.7
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4 and >=1:8 at Year 1, 3 and 5 in the ACWY1d and ACWY2d Groups
hSBA-MenC: >=1:8 (Year 1)
|
80.3 percentage of participants
Interval 69.1 to 88.8
|
90.5 percentage of participants
Interval 80.4 to 96.4
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4 and >=1:8 at Year 1, 3 and 5 in the ACWY1d and ACWY2d Groups
hSBA-MenW-135: >=1:8 (Year 1)
|
95.8 percentage of participants
Interval 88.3 to 99.1
|
98.5 percentage of participants
Interval 91.7 to 100.0
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4 and >=1:8 at Year 1, 3 and 5 in the ACWY1d and ACWY2d Groups
hSBA-MenY: >=1:8 (Year 1)
|
91.9 percentage of participants
Interval 82.2 to 97.3
|
87.9 percentage of participants
Interval 76.7 to 95.0
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4 and >=1:8 at Year 1, 3 and 5 in the ACWY1d and ACWY2d Groups
hSBA-MenA: >=1:4 (Year 3)
|
36.4 percentage of participants
Interval 23.8 to 50.4
|
36.0 percentage of participants
Interval 22.9 to 50.8
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4 and >=1:8 at Year 1, 3 and 5 in the ACWY1d and ACWY2d Groups
hSBA-MenC: >=1:4 (Year 3)
|
65.6 percentage of participants
Interval 52.3 to 77.3
|
67.9 percentage of participants
Interval 54.0 to 79.7
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4 and >=1:8 at Year 1, 3 and 5 in the ACWY1d and ACWY2d Groups
hSBA-MenW-135: >=1:4 (Year 3)
|
71.6 percentage of participants
Interval 59.3 to 82.0
|
87.0 percentage of participants
Interval 75.1 to 94.6
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4 and >=1:8 at Year 1, 3 and 5 in the ACWY1d and ACWY2d Groups
hSBA-MenY: >=1:4 (Year 3)
|
53.1 percentage of participants
Interval 40.2 to 65.7
|
61.5 percentage of participants
Interval 47.0 to 74.7
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4 and >=1:8 at Year 1, 3 and 5 in the ACWY1d and ACWY2d Groups
hSBA-MenA: >=1:8 (Year 3)
|
36.4 percentage of participants
Interval 23.8 to 50.4
|
36.0 percentage of participants
Interval 22.9 to 50.8
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4 and >=1:8 at Year 1, 3 and 5 in the ACWY1d and ACWY2d Groups
hSBA-MenC: >=1:8 (Year 3)
|
65.6 percentage of participants
Interval 52.3 to 77.3
|
67.9 percentage of participants
Interval 54.0 to 79.7
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4 and >=1:8 at Year 1, 3 and 5 in the ACWY1d and ACWY2d Groups
hSBA-MenW-135: >=1:8 (Year 3)
|
71.6 percentage of participants
Interval 59.3 to 82.0
|
87.0 percentage of participants
Interval 75.1 to 94.6
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4 and >=1:8 at Year 1, 3 and 5 in the ACWY1d and ACWY2d Groups
hSBA-MenY: >=1:8 (Year 3)
|
53.1 percentage of participants
Interval 40.2 to 65.7
|
61.5 percentage of participants
Interval 47.0 to 74.7
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4 and >=1:8 at Year 1, 3 and 5 in the ACWY1d and ACWY2d Groups
hSBA-MenA: >=1:4 (Year 5)
|
27.9 percentage of participants
Interval 17.1 to 40.8
|
17.9 percentage of participants
Interval 8.9 to 30.4
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4 and >=1:8 at Year 1, 3 and 5 in the ACWY1d and ACWY2d Groups
hSBA-MenC: >=1:4 (Year 5)
|
60.7 percentage of participants
Interval 47.3 to 72.9
|
67.8 percentage of participants
Interval 54.4 to 79.4
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4 and >=1:8 at Year 1, 3 and 5 in the ACWY1d and ACWY2d Groups
hSBA-MenW-135: >=1:4 (Year 5)
|
58.9 percentage of participants
Interval 45.0 to 71.9
|
63.6 percentage of participants
Interval 47.8 to 77.6
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4 and >=1:8 at Year 1, 3 and 5 in the ACWY1d and ACWY2d Groups
hSBA-MenY: >=1:4 (Year 5)
|
61.5 percentage of participants
Interval 48.6 to 73.3
|
54.2 percentage of participants
Interval 39.2 to 68.6
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4 and >=1:8 at Year 1, 3 and 5 in the ACWY1d and ACWY2d Groups
hSBA-MenA: >=1:8 (Year 5)
|
27.9 percentage of participants
Interval 17.1 to 40.8
|
17.9 percentage of participants
Interval 8.9 to 30.4
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4 and >=1:8 at Year 1, 3 and 5 in the ACWY1d and ACWY2d Groups
hSBA-MenC: >=1:8 (Year 5)
|
60.7 percentage of participants
Interval 47.3 to 72.9
|
67.8 percentage of participants
Interval 54.4 to 79.4
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4 and >=1:8 at Year 1, 3 and 5 in the ACWY1d and ACWY2d Groups
hSBA-MenW-135: >=1:8 (Year 5)
|
58.9 percentage of participants
Interval 45.0 to 71.9
|
63.6 percentage of participants
Interval 47.8 to 77.6
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4 and >=1:8 at Year 1, 3 and 5 in the ACWY1d and ACWY2d Groups
hSBA-MenY: >=1:8 (Year 5)
|
61.5 percentage of participants
Interval 48.6 to 73.3
|
54.2 percentage of participants
Interval 39.2 to 68.6
|
—
|
—
|
SECONDARY outcome
Timeframe: At Year 1, Year 3, Year 5Population: Analyzed on ATP cohort for persistence Year 1, 3 and 5 population. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure and 'number analyzed' signifies participants evaluable for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Co-ad and PCV13 reporting groups.
Geometric mean titers of antibodies against each serogroup were assessed using hSBA. Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). hSBA titers are expressed as 1/dilution. ATP cohort for persistence Year 1, 3 and 5 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.
Outcome measures
| Measure |
ACWY1d Group
n=72 Participants
Participants received single dose of meningococcal polysaccharide groups A, C, W-135, and Y tetanus toxoid conjugate (MenACWY-TT) vaccine administered intramuscularly at Month 0.
|
ACWY2d Group
n=65 Participants
Participants received two doses of MenACWY-TT vaccine administered intramuscularly at Month 0 and Month 2.
|
Co-ad Group
Participants received single dose of MenACWY-TT vaccine and single dose of Prevnar 13 administered intramuscularly at Month 0.
|
PCV13 Group
Participants received single dose of Prevnar 13 at Month 0 and single dose of MenACWY-TT administered intramuscularly at Month 2.
|
|---|---|---|---|---|
|
Geometric Mean Titers (GMTs) With hSBA for Each of the 4 Serogroups Following Vaccination at Year 1, 3 and 5 in the ACWY1d and ACWY2d Groups
hSBA-MenA (Year 1)
|
6.1 titers (1/dilution)
Interval 4.1 to 8.9
|
6.4 titers (1/dilution)
Interval 4.2 to 10.0
|
—
|
—
|
|
Geometric Mean Titers (GMTs) With hSBA for Each of the 4 Serogroups Following Vaccination at Year 1, 3 and 5 in the ACWY1d and ACWY2d Groups
hSBA-MenC (Year 1)
|
35.2 titers (1/dilution)
Interval 22.5 to 55.2
|
73.4 titers (1/dilution)
Interval 47.5 to 113.4
|
—
|
—
|
|
Geometric Mean Titers (GMTs) With hSBA for Each of the 4 Serogroups Following Vaccination at Year 1, 3 and 5 in the ACWY1d and ACWY2d Groups
hSBA-MenW-135 (Year 1)
|
209.0 titers (1/dilution)
Interval 149.9 to 291.4
|
232.6 titers (1/dilution)
Interval 168.3 to 321.4
|
—
|
—
|
|
Geometric Mean Titers (GMTs) With hSBA for Each of the 4 Serogroups Following Vaccination at Year 1, 3 and 5 in the ACWY1d and ACWY2d Groups
hSBA-MenY (Year 1)
|
144.4 titers (1/dilution)
Interval 97.2 to 214.5
|
143.9 titers (1/dilution)
Interval 88.5 to 233.8
|
—
|
—
|
|
Geometric Mean Titers (GMTs) With hSBA for Each of the 4 Serogroups Following Vaccination at Year 1, 3 and 5 in the ACWY1d and ACWY2d Groups
hSBA-MenA (Year 3)
|
5.8 titers (1/dilution)
Interval 3.8 to 8.9
|
5.4 titers (1/dilution)
Interval 3.6 to 8.0
|
—
|
—
|
|
Geometric Mean Titers (GMTs) With hSBA for Each of the 4 Serogroups Following Vaccination at Year 1, 3 and 5 in the ACWY1d and ACWY2d Groups
hSBA-MenC (Year 3)
|
23.6 titers (1/dilution)
Interval 13.9 to 40.2
|
27.0 titers (1/dilution)
Interval 15.6 to 46.8
|
—
|
—
|
|
Geometric Mean Titers (GMTs) With hSBA for Each of the 4 Serogroups Following Vaccination at Year 1, 3 and 5 in the ACWY1d and ACWY2d Groups
hSBA-MenW-135 (Year 3)
|
30.5 titers (1/dilution)
Interval 18.7 to 49.6
|
55.5 titers (1/dilution)
Interval 35.3 to 87.1
|
—
|
—
|
|
Geometric Mean Titers (GMTs) With hSBA for Each of the 4 Serogroups Following Vaccination at Year 1, 3 and 5 in the ACWY1d and ACWY2d Groups
hSBA-MenY (Year 3)
|
17.3 titers (1/dilution)
Interval 10.1 to 29.6
|
24.1 titers (1/dilution)
Interval 13.3 to 43.8
|
—
|
—
|
|
Geometric Mean Titers (GMTs) With hSBA for Each of the 4 Serogroups Following Vaccination at Year 1, 3 and 5 in the ACWY1d and ACWY2d Groups
hSBA-MenA (Year 5)
|
4.4 titers (1/dilution)
Interval 3.1 to 6.2
|
3.1 titers (1/dilution)
Interval 2.4 to 4.0
|
—
|
—
|
|
Geometric Mean Titers (GMTs) With hSBA for Each of the 4 Serogroups Following Vaccination at Year 1, 3 and 5 in the ACWY1d and ACWY2d Groups
hSBA-MenC (Year 5)
|
18.1 titers (1/dilution)
Interval 10.9 to 30.0
|
29.4 titers (1/dilution)
Interval 16.3 to 52.9
|
—
|
—
|
|
Geometric Mean Titers (GMTs) With hSBA for Each of the 4 Serogroups Following Vaccination at Year 1, 3 and 5 in the ACWY1d and ACWY2d Groups
hSBA-MenW-135 (Year 5)
|
20.8 titers (1/dilution)
Interval 11.6 to 37.1
|
19.5 titers (1/dilution)
Interval 10.7 to 35.2
|
—
|
—
|
|
Geometric Mean Titers (GMTs) With hSBA for Each of the 4 Serogroups Following Vaccination at Year 1, 3 and 5 in the ACWY1d and ACWY2d Groups
hSBA-MenY (Year 5)
|
24.3 titers (1/dilution)
Interval 14.3 to 41.1
|
16.8 titers (1/dilution)
Interval 9.0 to 31.3
|
—
|
—
|
SECONDARY outcome
Timeframe: At Year 1, Year 3, Year 5Population: Analyzed on ATP cohort for persistence Year 1, 3 and 5 population. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure and 'number analyzed' signifies participants evaluable for each specified category. Data for this outcome measure was not planned to be collected and analyzed for ACWY1d and ACWY2d reporting groups.
Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). Percentage of participants with rSBA titers \>=1:8 and \>=1:128 against each serogroup at Year 1, 3 and 5 after administration of MenACWY-TT are reported. ATP cohort for persistence Year 1, 3 and 5 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.
Outcome measures
| Measure |
ACWY1d Group
n=173 Participants
Participants received single dose of meningococcal polysaccharide groups A, C, W-135, and Y tetanus toxoid conjugate (MenACWY-TT) vaccine administered intramuscularly at Month 0.
|
ACWY2d Group
n=169 Participants
Participants received two doses of MenACWY-TT vaccine administered intramuscularly at Month 0 and Month 2.
|
Co-ad Group
Participants received single dose of MenACWY-TT vaccine and single dose of Prevnar 13 administered intramuscularly at Month 0.
|
PCV13 Group
Participants received single dose of Prevnar 13 at Month 0 and single dose of MenACWY-TT administered intramuscularly at Month 2.
|
|---|---|---|---|---|
|
Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at Year 1, 3 and 5 in the Co-ad and PCV-13 Groups
rSBA-MenC: >=1:128 (Year 1)
|
15.8 percentage of participants
Interval 10.7 to 22.1
|
20.1 percentage of participants
Interval 14.4 to 27.0
|
—
|
—
|
|
Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at Year 1, 3 and 5 in the Co-ad and PCV-13 Groups
rSBA-MenW-135: >=1:128 (Year 1)
|
42.7 percentage of participants
Interval 35.2 to 50.5
|
58.0 percentage of participants
Interval 50.2 to 65.5
|
—
|
—
|
|
Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at Year 1, 3 and 5 in the Co-ad and PCV-13 Groups
rSBA-MenY: >=1:128 (Year 1)
|
53.8 percentage of participants
Interval 46.0 to 61.4
|
69.2 percentage of participants
Interval 61.7 to 76.1
|
—
|
—
|
|
Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at Year 1, 3 and 5 in the Co-ad and PCV-13 Groups
rSBA-MenA: >=1:8 (Year 3)
|
51.0 percentage of participants
Interval 42.7 to 59.2
|
53.8 percentage of participants
Interval 44.9 to 62.5
|
—
|
—
|
|
Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at Year 1, 3 and 5 in the Co-ad and PCV-13 Groups
rSBA-MenC: >=1:8 (Year 3)
|
28.5 percentage of participants
Interval 21.4 to 36.4
|
31.8 percentage of participants
Interval 24.0 to 40.5
|
—
|
—
|
|
Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at Year 1, 3 and 5 in the Co-ad and PCV-13 Groups
rSBA-MenW-135: >=1:8 (Year 3)
|
53.0 percentage of participants
Interval 44.7 to 61.1
|
56.8 percentage of participants
Interval 47.9 to 65.4
|
—
|
—
|
|
Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at Year 1, 3 and 5 in the Co-ad and PCV-13 Groups
rSBA-MenY: >=1:8 (Year 3)
|
62.9 percentage of participants
Interval 54.7 to 70.6
|
73.5 percentage of participants
Interval 65.1 to 80.8
|
—
|
—
|
|
Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at Year 1, 3 and 5 in the Co-ad and PCV-13 Groups
rSBA-MenA: >=1:128 (Year 3)
|
39.1 percentage of participants
Interval 31.2 to 47.3
|
40.2 percentage of participants
Interval 31.7 to 49.0
|
—
|
—
|
|
Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at Year 1, 3 and 5 in the Co-ad and PCV-13 Groups
rSBA-MenC: >=1:128 (Year 3)
|
14.6 percentage of participants
Interval 9.4 to 21.2
|
10.6 percentage of participants
Interval 5.9 to 17.2
|
—
|
—
|
|
Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at Year 1, 3 and 5 in the Co-ad and PCV-13 Groups
rSBA-MenW-135: >=1:128 (Year 3)
|
39.1 percentage of participants
Interval 31.2 to 47.3
|
42.4 percentage of participants
Interval 33.9 to 51.3
|
—
|
—
|
|
Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at Year 1, 3 and 5 in the Co-ad and PCV-13 Groups
rSBA-MenY: >=1:128 (Year 3)
|
53.0 percentage of participants
Interval 44.7 to 61.1
|
59.8 percentage of participants
Interval 51.0 to 68.3
|
—
|
—
|
|
Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at Year 1, 3 and 5 in the Co-ad and PCV-13 Groups
rSBA-MenA: >=1:8 (Year 5)
|
45.8 percentage of participants
Interval 37.4 to 54.3
|
47.3 percentage of participants
Interval 38.4 to 56.3
|
—
|
—
|
|
Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at Year 1, 3 and 5 in the Co-ad and PCV-13 Groups
rSBA-MenC: >=1:8 (Year 5)
|
23.9 percentage of participants
Interval 17.2 to 31.8
|
19.4 percentage of participants
Interval 13.0 to 27.3
|
—
|
—
|
|
Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at Year 1, 3 and 5 in the Co-ad and PCV-13 Groups
rSBA-MenW-135: >=1:8 (Year 5)
|
43.0 percentage of participants
Interval 34.7 to 51.5
|
45.0 percentage of participants
Interval 36.2 to 54.0
|
—
|
—
|
|
Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at Year 1, 3 and 5 in the Co-ad and PCV-13 Groups
rSBA-MenY: >=1:8 (Year 5)
|
52.8 percentage of participants
Interval 44.3 to 61.2
|
55.8 percentage of participants
Interval 46.8 to 64.5
|
—
|
—
|
|
Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at Year 1, 3 and 5 in the Co-ad and PCV-13 Groups
rSBA-MenA: >=1:128 (Year 5)
|
19.0 percentage of participants
Interval 12.9 to 26.4
|
36.4 percentage of participants
Interval 28.1 to 45.4
|
—
|
—
|
|
Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at Year 1, 3 and 5 in the Co-ad and PCV-13 Groups
rSBA-MenA: >=1:8 (Year 1)
|
66.5 percentage of participants
Interval 58.9 to 73.5
|
70.4 percentage of participants
Interval 62.9 to 77.2
|
—
|
—
|
|
Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at Year 1, 3 and 5 in the Co-ad and PCV-13 Groups
rSBA-MenC: >=1:8 (Year 1)
|
42.7 percentage of participants
Interval 35.2 to 50.5
|
50.3 percentage of participants
Interval 42.5 to 58.1
|
—
|
—
|
|
Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at Year 1, 3 and 5 in the Co-ad and PCV-13 Groups
rSBA-MenW-135: >=1:8 (Year 1)
|
60.2 percentage of participants
Interval 52.5 to 67.6
|
72.8 percentage of participants
Interval 65.4 to 79.3
|
—
|
—
|
|
Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at Year 1, 3 and 5 in the Co-ad and PCV-13 Groups
rSBA-MenY: >=1:8 (Year 1)
|
67.1 percentage of participants
Interval 59.5 to 74.0
|
80.5 percentage of participants
Interval 73.7 to 86.2
|
—
|
—
|
|
Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at Year 1, 3 and 5 in the Co-ad and PCV-13 Groups
rSBA-MenA: >=1:128 (Year 1)
|
42.8 percentage of participants
Interval 35.3 to 50.5
|
56.2 percentage of participants
Interval 48.4 to 63.8
|
—
|
—
|
|
Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at Year 1, 3 and 5 in the Co-ad and PCV-13 Groups
rSBA-MenC: >=1:128 (Year 5)
|
12.0 percentage of participants
Interval 7.1 to 18.5
|
7.8 percentage of participants
Interval 3.8 to 13.8
|
—
|
—
|
|
Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at Year 1, 3 and 5 in the Co-ad and PCV-13 Groups
rSBA-MenW-135: >=1:128 (Year 5)
|
33.8 percentage of participants
Interval 26.1 to 42.2
|
35.7 percentage of participants
Interval 27.4 to 44.6
|
—
|
—
|
|
Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at Year 1, 3 and 5 in the Co-ad and PCV-13 Groups
rSBA-MenY: >=1:128 (Year 5)
|
42.3 percentage of participants
Interval 34.0 to 50.8
|
48.1 percentage of participants
Interval 39.2 to 57.0
|
—
|
—
|
SECONDARY outcome
Timeframe: At Year 1, Year 3, Year 5Population: Analyzed on ATP cohort for persistence Year 1, 3 and 5 population. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure and 'number analyzed' signifies participants evaluable for each specified category. Data for this outcome measure was not planned to be collected and analyzed for ACWY1d and ACWY2d reporting groups.
Geometric mean titers of antibodies against each serogroup were assessed using rSBA. Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). rSBA titers are expressed as 1/dilution. ATP cohort for persistence Year 1, 3 and 5 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.
Outcome measures
| Measure |
ACWY1d Group
n=173 Participants
Participants received single dose of meningococcal polysaccharide groups A, C, W-135, and Y tetanus toxoid conjugate (MenACWY-TT) vaccine administered intramuscularly at Month 0.
|
ACWY2d Group
n=169 Participants
Participants received two doses of MenACWY-TT vaccine administered intramuscularly at Month 0 and Month 2.
|
Co-ad Group
Participants received single dose of MenACWY-TT vaccine and single dose of Prevnar 13 administered intramuscularly at Month 0.
|
PCV13 Group
Participants received single dose of Prevnar 13 at Month 0 and single dose of MenACWY-TT administered intramuscularly at Month 2.
|
|---|---|---|---|---|
|
Geometric Mean Titers (GMTs) With rSBA for Each of the 4 Serogroups Following Vaccination at Year 1, 3 and 5 in the Co-ad and PCV-13 Groups
rSBA-MenA (Year 1)
|
59.5 titers (1/dilution)
Interval 40.7 to 87.2
|
119.4 titers (1/dilution)
Interval 79.5 to 179.3
|
—
|
—
|
|
Geometric Mean Titers (GMTs) With rSBA for Each of the 4 Serogroups Following Vaccination at Year 1, 3 and 5 in the Co-ad and PCV-13 Groups
rSBA-MenC (Year 1)
|
12.6 titers (1/dilution)
Interval 10.0 to 16.0
|
16.0 titers (1/dilution)
Interval 12.2 to 20.9
|
—
|
—
|
|
Geometric Mean Titers (GMTs) With rSBA for Each of the 4 Serogroups Following Vaccination at Year 1, 3 and 5 in the Co-ad and PCV-13 Groups
rSBA-MenW-135 (Year 1)
|
52.0 titers (1/dilution)
Interval 35.5 to 76.4
|
109.5 titers (1/dilution)
Interval 75.0 to 160.0
|
—
|
—
|
|
Geometric Mean Titers (GMTs) With rSBA for Each of the 4 Serogroups Following Vaccination at Year 1, 3 and 5 in the Co-ad and PCV-13 Groups
rSBA-MenY (Year 1)
|
70.7 titers (1/dilution)
Interval 49.0 to 102.1
|
169.2 titers (1/dilution)
Interval 119.2 to 240.1
|
—
|
—
|
|
Geometric Mean Titers (GMTs) With rSBA for Each of the 4 Serogroups Following Vaccination at Year 1, 3 and 5 in the Co-ad and PCV-13 Groups
rSBA-MenA (Year 3)
|
38.6 titers (1/dilution)
Interval 25.4 to 58.8
|
42.3 titers (1/dilution)
Interval 27.2 to 65.6
|
—
|
—
|
|
Geometric Mean Titers (GMTs) With rSBA for Each of the 4 Serogroups Following Vaccination at Year 1, 3 and 5 in the Co-ad and PCV-13 Groups
rSBA-MenC (Year 3)
|
9.1 titers (1/dilution)
Interval 7.1 to 11.6
|
9.3 titers (1/dilution)
Interval 7.1 to 12.1
|
—
|
—
|
|
Geometric Mean Titers (GMTs) With rSBA for Each of the 4 Serogroups Following Vaccination at Year 1, 3 and 5 in the Co-ad and PCV-13 Groups
rSBA-MenW-135 (Year 3)
|
34.4 titers (1/dilution)
Interval 23.4 to 50.6
|
44.5 titers (1/dilution)
Interval 28.9 to 68.7
|
—
|
—
|
|
Geometric Mean Titers (GMTs) With rSBA for Each of the 4 Serogroups Following Vaccination at Year 1, 3 and 5 in the Co-ad and PCV-13 Groups
rSBA-MenY (Year 3)
|
67.6 titers (1/dilution)
Interval 45.6 to 100.3
|
106.0 titers (1/dilution)
Interval 70.2 to 160.0
|
—
|
—
|
|
Geometric Mean Titers (GMTs) With rSBA for Each of the 4 Serogroups Following Vaccination at Year 1, 3 and 5 in the Co-ad and PCV-13 Groups
rSBA-MenA (Year 5)
|
15.4 titers (1/dilution)
Interval 11.1 to 21.3
|
28.3 titers (1/dilution)
Interval 18.5 to 43.2
|
—
|
—
|
|
Geometric Mean Titers (GMTs) With rSBA for Each of the 4 Serogroups Following Vaccination at Year 1, 3 and 5 in the Co-ad and PCV-13 Groups
rSBA-MenC (Year 5)
|
7.9 titers (1/dilution)
Interval 6.2 to 10.0
|
7.0 titers (1/dilution)
Interval 5.5 to 8.8
|
—
|
—
|
|
Geometric Mean Titers (GMTs) With rSBA for Each of the 4 Serogroups Following Vaccination at Year 1, 3 and 5 in the Co-ad and PCV-13 Groups
rSBA-MenW-135 (Year 5)
|
26.2 titers (1/dilution)
Interval 17.6 to 39.0
|
31.7 titers (1/dilution)
Interval 20.2 to 49.6
|
—
|
—
|
|
Geometric Mean Titers (GMTs) With rSBA for Each of the 4 Serogroups Following Vaccination at Year 1, 3 and 5 in the Co-ad and PCV-13 Groups
rSBA-MenY (Year 5)
|
43.3 titers (1/dilution)
Interval 28.3 to 66.2
|
53.9 titers (1/dilution)
Interval 34.5 to 84.2
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 month after administration of Prevnar 13 (i.e. at Month 1)Population: Analyzed on ATP cohort for immunogenicity post dose 1 population. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure and 'number analyzed' signifies participants evaluable for each specified category. Data for this outcome measure was not planned to be collected and analyzed for ACWY1d and ACWY2d reporting groups.
Antibody concentrations were determined for anti-pneumococcal antibodies: anti-1, anti-3, anti-4, anti-5, anti-6A, anti-6B, anti-7F, anti-9V, anti-14, anti-18C, anti-19A, anti-19F and anti-23F. Percentage of participants with antibody concentrations \>=0.15 mcg/mL, \>=0.26 mcg/mL and \>=0.35 mcg/mL against each serogroup at 1 month after administration of Prevnar 13 are reported. ATP cohort for immunogenicity post dose 1 included all evaluable participants who met eligibility criteria, complied with the procedures defined in the protocol and with no elimination criteria during the study from the ATP cohort for safety, received all study vaccines at Month 0, had assay results available for antibodies against at least one study vaccine antigen component at Visit 2, those with available blood sample at Visit 2 for PCV13 group.
Outcome measures
| Measure |
ACWY1d Group
n=163 Participants
Participants received single dose of meningococcal polysaccharide groups A, C, W-135, and Y tetanus toxoid conjugate (MenACWY-TT) vaccine administered intramuscularly at Month 0.
|
ACWY2d Group
n=172 Participants
Participants received two doses of MenACWY-TT vaccine administered intramuscularly at Month 0 and Month 2.
|
Co-ad Group
Participants received single dose of MenACWY-TT vaccine and single dose of Prevnar 13 administered intramuscularly at Month 0.
|
PCV13 Group
Participants received single dose of Prevnar 13 at Month 0 and single dose of MenACWY-TT administered intramuscularly at Month 2.
|
|---|---|---|---|---|
|
Percentage of Participants With Antibody Concentrations >=0.15 mcg/mL, >=0.26 mcg/mL and >=0.35 mcg/mL for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups
anti-1 (>=0.15 mcg/mL)
|
100 percentage of participants
Interval 97.7 to 100.0
|
100 percentage of participants
Interval 97.9 to 100.0
|
—
|
—
|
|
Percentage of Participants With Antibody Concentrations >=0.15 mcg/mL, >=0.26 mcg/mL and >=0.35 mcg/mL for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups
anti-3 (>=0.15 mcg/mL)
|
99.3 percentage of participants
Interval 96.4 to 100.0
|
97.5 percentage of participants
Interval 93.8 to 99.3
|
—
|
—
|
|
Percentage of Participants With Antibody Concentrations >=0.15 mcg/mL, >=0.26 mcg/mL and >=0.35 mcg/mL for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups
anti-4 (>=0.15 mcg/mL)
|
100 percentage of participants
Interval 97.8 to 100.0
|
99.4 percentage of participants
Interval 96.8 to 100.0
|
—
|
—
|
|
Percentage of Participants With Antibody Concentrations >=0.15 mcg/mL, >=0.26 mcg/mL and >=0.35 mcg/mL for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups
anti-5 (>=0.15 mcg/mL)
|
100 percentage of participants
Interval 97.8 to 100.0
|
100 percentage of participants
Interval 97.9 to 100.0
|
—
|
—
|
|
Percentage of Participants With Antibody Concentrations >=0.15 mcg/mL, >=0.26 mcg/mL and >=0.35 mcg/mL for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups
anti-6A (>=0.15 mcg/mL)
|
100 percentage of participants
Interval 97.8 to 100.0
|
100 percentage of participants
Interval 97.9 to 100.0
|
—
|
—
|
|
Percentage of Participants With Antibody Concentrations >=0.15 mcg/mL, >=0.26 mcg/mL and >=0.35 mcg/mL for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups
anti-6B (>=0.15 mcg/mL)
|
100 percentage of participants
Interval 97.7 to 100.0
|
99.4 percentage of participants
Interval 96.8 to 100.0
|
—
|
—
|
|
Percentage of Participants With Antibody Concentrations >=0.15 mcg/mL, >=0.26 mcg/mL and >=0.35 mcg/mL for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups
anti-7F (>=0.15 mcg/mL)
|
100 percentage of participants
Interval 97.8 to 100.0
|
100 percentage of participants
Interval 97.9 to 100.0
|
—
|
—
|
|
Percentage of Participants With Antibody Concentrations >=0.15 mcg/mL, >=0.26 mcg/mL and >=0.35 mcg/mL for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups
anti-9V (>=0.15 mcg/mL)
|
99.4 percentage of participants
Interval 96.6 to 100.0
|
100 percentage of participants
Interval 97.9 to 100.0
|
—
|
—
|
|
Percentage of Participants With Antibody Concentrations >=0.15 mcg/mL, >=0.26 mcg/mL and >=0.35 mcg/mL for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups
anti-14 (>=0.15 mcg/mL)
|
100 percentage of participants
Interval 97.7 to 100.0
|
99.4 percentage of participants
Interval 96.8 to 100.0
|
—
|
—
|
|
Percentage of Participants With Antibody Concentrations >=0.15 mcg/mL, >=0.26 mcg/mL and >=0.35 mcg/mL for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups
anti-18C (>=0.15 mcg/mL)
|
100 percentage of participants
Interval 97.8 to 100.0
|
100 percentage of participants
Interval 97.9 to 100.0
|
—
|
—
|
|
Percentage of Participants With Antibody Concentrations >=0.15 mcg/mL, >=0.26 mcg/mL and >=0.35 mcg/mL for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups
anti-19A (>=0.15 mcg/mL)
|
100 percentage of participants
Interval 97.7 to 100.0
|
100 percentage of participants
Interval 97.9 to 100.0
|
—
|
—
|
|
Percentage of Participants With Antibody Concentrations >=0.15 mcg/mL, >=0.26 mcg/mL and >=0.35 mcg/mL for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups
anti-19F (>=0.15 mcg/mL)
|
100 percentage of participants
Interval 97.7 to 100.0
|
100 percentage of participants
Interval 97.9 to 100.0
|
—
|
—
|
|
Percentage of Participants With Antibody Concentrations >=0.15 mcg/mL, >=0.26 mcg/mL and >=0.35 mcg/mL for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups
anti-23F (>=0.15 mcg/mL)
|
100 percentage of participants
Interval 97.7 to 100.0
|
100 percentage of participants
Interval 97.8 to 100.0
|
—
|
—
|
|
Percentage of Participants With Antibody Concentrations >=0.15 mcg/mL, >=0.26 mcg/mL and >=0.35 mcg/mL for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups
anti-1 (>=0.26 mcg/mL)
|
99.4 percentage of participants
Interval 96.6 to 100.0
|
99.4 percentage of participants
Interval 96.8 to 100.0
|
—
|
—
|
|
Percentage of Participants With Antibody Concentrations >=0.15 mcg/mL, >=0.26 mcg/mL and >=0.35 mcg/mL for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups
anti-3 (>=0.26 mcg/mL)
|
94.0 percentage of participants
Interval 89.0 to 97.2
|
88.3 percentage of participants
Interval 82.3 to 92.8
|
—
|
—
|
|
Percentage of Participants With Antibody Concentrations >=0.15 mcg/mL, >=0.26 mcg/mL and >=0.35 mcg/mL for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups
anti-4 (>=0.26 mcg/mL)
|
98.8 percentage of participants
Interval 95.6 to 99.9
|
98.3 percentage of participants
Interval 95.0 to 99.6
|
—
|
—
|
|
Percentage of Participants With Antibody Concentrations >=0.15 mcg/mL, >=0.26 mcg/mL and >=0.35 mcg/mL for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups
anti-5 (>=0.26 mcg/mL)
|
99.4 percentage of participants
Interval 96.6 to 100.0
|
98.8 percentage of participants
Interval 95.9 to 99.9
|
—
|
—
|
|
Percentage of Participants With Antibody Concentrations >=0.15 mcg/mL, >=0.26 mcg/mL and >=0.35 mcg/mL for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups
anti-6A (>=0.26 mcg/mL)
|
100 percentage of participants
Interval 97.8 to 100.0
|
100 percentage of participants
Interval 97.9 to 100.0
|
—
|
—
|
|
Percentage of Participants With Antibody Concentrations >=0.15 mcg/mL, >=0.26 mcg/mL and >=0.35 mcg/mL for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups
anti-6B (>=0.26 mcg/mL)
|
100 percentage of participants
Interval 97.7 to 100.0
|
99.4 percentage of participants
Interval 96.8 to 100.0
|
—
|
—
|
|
Percentage of Participants With Antibody Concentrations >=0.15 mcg/mL, >=0.26 mcg/mL and >=0.35 mcg/mL for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups
anti-7F (>=0.26 mcg/mL)
|
100 percentage of participants
Interval 97.8 to 100.0
|
100 percentage of participants
Interval 97.9 to 100.0
|
—
|
—
|
|
Percentage of Participants With Antibody Concentrations >=0.15 mcg/mL, >=0.26 mcg/mL and >=0.35 mcg/mL for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups
anti-9V (>=0.26 mcg/mL)
|
99.4 percentage of participants
Interval 96.6 to 100.0
|
98.8 percentage of participants
Interval 95.9 to 99.9
|
—
|
—
|
|
Percentage of Participants With Antibody Concentrations >=0.15 mcg/mL, >=0.26 mcg/mL and >=0.35 mcg/mL for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups
anti-14 (>=0.26 mcg/mL)
|
100 percentage of participants
Interval 97.7 to 100.0
|
99.4 percentage of participants
Interval 96.8 to 100.0
|
—
|
—
|
|
Percentage of Participants With Antibody Concentrations >=0.15 mcg/mL, >=0.26 mcg/mL and >=0.35 mcg/mL for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups
anti-18C (>=0.26 mcg/mL)
|
98.8 percentage of participants
Interval 95.6 to 99.9
|
99.4 percentage of participants
Interval 96.8 to 100.0
|
—
|
—
|
|
Percentage of Participants With Antibody Concentrations >=0.15 mcg/mL, >=0.26 mcg/mL and >=0.35 mcg/mL for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups
anti-19A (>=0.26 mcg/mL)
|
100 percentage of participants
Interval 97.7 to 100.0
|
100 percentage of participants
Interval 97.9 to 100.0
|
—
|
—
|
|
Percentage of Participants With Antibody Concentrations >=0.15 mcg/mL, >=0.26 mcg/mL and >=0.35 mcg/mL for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups
anti-19F (>=0.26 mcg/mL)
|
100 percentage of participants
Interval 97.7 to 100.0
|
100 percentage of participants
Interval 97.9 to 100.0
|
—
|
—
|
|
Percentage of Participants With Antibody Concentrations >=0.15 mcg/mL, >=0.26 mcg/mL and >=0.35 mcg/mL for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups
anti-23F (>=0.26 mcg/mL)
|
99.4 percentage of participants
Interval 96.6 to 100.0
|
99.4 percentage of participants
Interval 96.7 to 100.0
|
—
|
—
|
|
Percentage of Participants With Antibody Concentrations >=0.15 mcg/mL, >=0.26 mcg/mL and >=0.35 mcg/mL for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups
anti-1 (>=0.35 mcg/mL)
|
99.4 percentage of participants
Interval 96.6 to 100.0
|
98.2 percentage of participants
Interval 95.0 to 99.6
|
—
|
—
|
|
Percentage of Participants With Antibody Concentrations >=0.15 mcg/mL, >=0.26 mcg/mL and >=0.35 mcg/mL for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups
anti-3 (>=0.35 mcg/mL)
|
83.4 percentage of participants
Interval 76.5 to 89.0
|
79.0 percentage of participants
Interval 71.9 to 85.0
|
—
|
—
|
|
Percentage of Participants With Antibody Concentrations >=0.15 mcg/mL, >=0.26 mcg/mL and >=0.35 mcg/mL for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups
anti-6A (>=0.35 mcg/mL)
|
99.4 percentage of participants
Interval 96.6 to 100.0
|
100 percentage of participants
Interval 97.9 to 100.0
|
—
|
—
|
|
Percentage of Participants With Antibody Concentrations >=0.15 mcg/mL, >=0.26 mcg/mL and >=0.35 mcg/mL for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups
anti-6B (>=0.35 mcg/mL)
|
99.4 percentage of participants
Interval 96.6 to 100.0
|
99.4 percentage of participants
Interval 96.8 to 100.0
|
—
|
—
|
|
Percentage of Participants With Antibody Concentrations >=0.15 mcg/mL, >=0.26 mcg/mL and >=0.35 mcg/mL for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups
anti-7F (>=0.35 mcg/mL)
|
99.4 percentage of participants
Interval 96.6 to 100.0
|
100 percentage of participants
Interval 97.9 to 100.0
|
—
|
—
|
|
Percentage of Participants With Antibody Concentrations >=0.15 mcg/mL, >=0.26 mcg/mL and >=0.35 mcg/mL for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups
anti-9V (>=0.35 mcg/mL)
|
99.4 percentage of participants
Interval 96.6 to 100.0
|
97.7 percentage of participants
Interval 94.2 to 99.4
|
—
|
—
|
|
Percentage of Participants With Antibody Concentrations >=0.15 mcg/mL, >=0.26 mcg/mL and >=0.35 mcg/mL for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups
anti-14 (>=0.35 mcg/mL)
|
100 percentage of participants
Interval 97.7 to 100.0
|
99.4 percentage of participants
Interval 96.8 to 100.0
|
—
|
—
|
|
Percentage of Participants With Antibody Concentrations >=0.15 mcg/mL, >=0.26 mcg/mL and >=0.35 mcg/mL for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups
anti-18C (>=0.35 mcg/mL)
|
98.8 percentage of participants
Interval 95.6 to 99.9
|
99.4 percentage of participants
Interval 96.8 to 100.0
|
—
|
—
|
|
Percentage of Participants With Antibody Concentrations >=0.15 mcg/mL, >=0.26 mcg/mL and >=0.35 mcg/mL for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups
anti-19A (>=0.35 mcg/mL)
|
100 percentage of participants
Interval 97.7 to 100.0
|
100 percentage of participants
Interval 97.9 to 100.0
|
—
|
—
|
|
Percentage of Participants With Antibody Concentrations >=0.15 mcg/mL, >=0.26 mcg/mL and >=0.35 mcg/mL for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups
anti-19F (>=0.35 mcg/mL)
|
100 percentage of participants
Interval 97.7 to 100.0
|
100 percentage of participants
Interval 97.9 to 100.0
|
—
|
—
|
|
Percentage of Participants With Antibody Concentrations >=0.15 mcg/mL, >=0.26 mcg/mL and >=0.35 mcg/mL for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups
anti-23F (>=0.35 mcg/mL)
|
99.4 percentage of participants
Interval 96.6 to 100.0
|
99.4 percentage of participants
Interval 96.7 to 100.0
|
—
|
—
|
|
Percentage of Participants With Antibody Concentrations >=0.15 mcg/mL, >=0.26 mcg/mL and >=0.35 mcg/mL for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups
anti-4 (>=0.35 mcg/mL)
|
96.9 percentage of participants
Interval 93.0 to 99.0
|
97.1 percentage of participants
Interval 93.3 to 99.0
|
—
|
—
|
|
Percentage of Participants With Antibody Concentrations >=0.15 mcg/mL, >=0.26 mcg/mL and >=0.35 mcg/mL for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups
anti-5 (>=0.35 mcg/mL)
|
98.8 percentage of participants
Interval 95.6 to 99.9
|
94.8 percentage of participants
Interval 90.3 to 97.6
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 month after administration of Prevnar 13 (i.e. at Month 1)Population: Analyzed on ATP cohort for immunogenicity post dose 1 population. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure and 'number analyzed' signifies participants evaluable for each specified category. Data for this outcome measure was not planned to be collected and analyzed for ACWY1d and ACWY2d reporting groups.
OPA titers were determined for anti-pneumococcal serotypes: OPSONO-1, OPSONO-3, OPSONO-4, OPSONO-5, OPSONO-6A, OPSONO-6B, OPSONO-7F, OPSONO-9V, OPSONO-14, OPSONO-18C, OPSONO-19A, OPSONO-19F and OPSONO-23F. Percentage of participants with OPA titers \>=1:8 against each serogroup at 1 month after administration of Prevnar 13 are reported. ATP cohort for immunogenicity post dose 1 included all evaluable participants who met eligibility criteria, complied with the procedures defined in the protocol and with no elimination criteria during the study from the ATP cohort for safety, received all study vaccines at Month 0, had assay results available for antibodies against at least one study vaccine antigen component at Visit 2, those with available blood sample at Visit 2 for PCV13 group.
Outcome measures
| Measure |
ACWY1d Group
n=81 Participants
Participants received single dose of meningococcal polysaccharide groups A, C, W-135, and Y tetanus toxoid conjugate (MenACWY-TT) vaccine administered intramuscularly at Month 0.
|
ACWY2d Group
n=88 Participants
Participants received two doses of MenACWY-TT vaccine administered intramuscularly at Month 0 and Month 2.
|
Co-ad Group
Participants received single dose of MenACWY-TT vaccine and single dose of Prevnar 13 administered intramuscularly at Month 0.
|
PCV13 Group
Participants received single dose of Prevnar 13 at Month 0 and single dose of MenACWY-TT administered intramuscularly at Month 2.
|
|---|---|---|---|---|
|
Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >=1:8 for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups
OPSONO-1
|
93.8 percentage of participants
Interval 86.2 to 98.0
|
90.7 percentage of participants
Interval 82.5 to 95.9
|
—
|
—
|
|
Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >=1:8 for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups
OPSONO-5
|
100 percentage of participants
Interval 95.5 to 100.0
|
100 percentage of participants
Interval 95.8 to 100.0
|
—
|
—
|
|
Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >=1:8 for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups
OPSONO-6A
|
100 percentage of participants
Interval 95.5 to 100.0
|
100 percentage of participants
Interval 95.9 to 100.0
|
—
|
—
|
|
Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >=1:8 for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups
OPSONO-6B
|
100 percentage of participants
Interval 95.2 to 100.0
|
100 percentage of participants
Interval 95.4 to 100.0
|
—
|
—
|
|
Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >=1:8 for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups
OPSONO-7F
|
100 percentage of participants
Interval 95.5 to 100.0
|
100 percentage of participants
Interval 95.8 to 100.0
|
—
|
—
|
|
Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >=1:8 for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups
OPSONO-9V
|
100 percentage of participants
Interval 95.5 to 100.0
|
100 percentage of participants
Interval 95.9 to 100.0
|
—
|
—
|
|
Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >=1:8 for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups
OPSONO-14
|
100 percentage of participants
Interval 95.1 to 100.0
|
100 percentage of participants
Interval 95.4 to 100.0
|
—
|
—
|
|
Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >=1:8 for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups
OPSONO-18C
|
100 percentage of participants
Interval 95.5 to 100.0
|
100 percentage of participants
Interval 95.9 to 100.0
|
—
|
—
|
|
Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >=1:8 for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups
OPSONO-19A
|
100 percentage of participants
Interval 95.5 to 100.0
|
100 percentage of participants
Interval 95.9 to 100.0
|
—
|
—
|
|
Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >=1:8 for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups
OPSONO-19F
|
98.8 percentage of participants
Interval 93.3 to 100.0
|
100 percentage of participants
Interval 95.9 to 100.0
|
—
|
—
|
|
Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >=1:8 for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups
OPSONO-3
|
98.7 percentage of participants
Interval 92.9 to 100.0
|
100 percentage of participants
Interval 95.5 to 100.0
|
—
|
—
|
|
Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >=1:8 for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups
OPSONO-4
|
100 percentage of participants
Interval 95.3 to 100.0
|
100 percentage of participants
Interval 95.5 to 100.0
|
—
|
—
|
|
Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >=1:8 for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups
OPSONO-23F
|
98.7 percentage of participants
Interval 93.0 to 100.0
|
98.8 percentage of participants
Interval 93.2 to 100.0
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 month after administration of Prevnar 13 (i.e. at Month 1)Population: Analyzed on ATP cohort for immunogenicity post dose 1 population. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure and 'number analyzed' signifies participants evaluable for each specified category. Data for this outcome measure was not planned to be collected and analyzed for ACWY1d and ACWY2d reporting groups.
OPA titers were determined for anti-pneumococcal serotypes: OPSONO-1, OPSONO-3, OPSONO-4, OPSONO-5, OPSONO-6A, OPSONO-6B, OPSONO-7F, OPSONO-9V, OPSONO-14, OPSONO-18C, OPSONO-19A, OPSONO-19F and OPSONO-23F. OPA titers are expressed as 1/dilution. ATP cohort for immunogenicity post dose 1 included all evaluable participants who met eligibility criteria, complied with the procedures defined in the protocol and with no elimination criteria during the study from the ATP cohort for safety, received all study vaccines at Month 0, had assay results available for antibodies against at least one study vaccine antigen component at Visit 2, those with available blood sample at Visit 2 for PCV13 group.
Outcome measures
| Measure |
ACWY1d Group
n=81 Participants
Participants received single dose of meningococcal polysaccharide groups A, C, W-135, and Y tetanus toxoid conjugate (MenACWY-TT) vaccine administered intramuscularly at Month 0.
|
ACWY2d Group
n=88 Participants
Participants received two doses of MenACWY-TT vaccine administered intramuscularly at Month 0 and Month 2.
|
Co-ad Group
Participants received single dose of MenACWY-TT vaccine and single dose of Prevnar 13 administered intramuscularly at Month 0.
|
PCV13 Group
Participants received single dose of Prevnar 13 at Month 0 and single dose of MenACWY-TT administered intramuscularly at Month 2.
|
|---|---|---|---|---|
|
Geometric Mean Titers (GMTs) With OPA for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups
OPSONO-1
|
116.1 titers
Interval 83.8 to 160.7
|
106.1 titers
Interval 77.0 to 146.2
|
—
|
—
|
|
Geometric Mean Titers (GMTs) With OPA for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups
OPSONO-4
|
2194.8 titers
Interval 1660.0 to 2901.9
|
2210.1 titers
Interval 1735.0 to 2815.2
|
—
|
—
|
|
Geometric Mean Titers (GMTs) With OPA for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups
OPSONO-5
|
452.3 titers
Interval 360.4 to 567.5
|
404.6 titers
Interval 319.1 to 512.9
|
—
|
—
|
|
Geometric Mean Titers (GMTs) With OPA for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups
OPSONO-6A
|
10177.2 titers
Interval 7784.7 to 13305.1
|
7354.2 titers
Interval 5707.4 to 9476.1
|
—
|
—
|
|
Geometric Mean Titers (GMTs) With OPA for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups
OPSONO-6B
|
4952.3 titers
Interval 3734.4 to 6567.4
|
3881.5 titers
Interval 3055.8 to 4930.2
|
—
|
—
|
|
Geometric Mean Titers (GMTs) With OPA for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups
OPSONO-7F
|
8957.4 titers
Interval 7306.4 to 10981.5
|
8526.5 titers
Interval 6926.2 to 10496.7
|
—
|
—
|
|
Geometric Mean Titers (GMTs) With OPA for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups
OPSONO-9V
|
3375.5 titers
Interval 2539.6 to 4486.6
|
2332.3 titers
Interval 1766.1 to 3080.1
|
—
|
—
|
|
Geometric Mean Titers (GMTs) With OPA for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups
OPSONO-14
|
3443.7 titers
Interval 2453.5 to 4833.5
|
3157.8 titers
Interval 2445.4 to 4077.8
|
—
|
—
|
|
Geometric Mean Titers (GMTs) With OPA for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups
OPSONO-18C
|
3881.0 titers
Interval 2947.2 to 5110.7
|
3289.8 titers
Interval 2513.7 to 4305.5
|
—
|
—
|
|
Geometric Mean Titers (GMTs) With OPA for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups
OPSONO-19A
|
3362.5 titers
Interval 2639.6 to 4283.4
|
2494.3 titers
Interval 1986.7 to 3131.6
|
—
|
—
|
|
Geometric Mean Titers (GMTs) With OPA for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups
OPSONO-19F
|
1795.5 titers
Interval 1305.6 to 2469.2
|
1647.6 titers
Interval 1287.6 to 2108.3
|
—
|
—
|
|
Geometric Mean Titers (GMTs) With OPA for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups
OPSONO-23F
|
7755.7 titers
Interval 5450.9 to 11034.9
|
5677.4 titers
Interval 4255.0 to 7575.3
|
—
|
—
|
|
Geometric Mean Titers (GMTs) With OPA for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups
OPSONO-3
|
137.6 titers
Interval 106.4 to 178.0
|
122.0 titers
Interval 100.6 to 147.9
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 4 days post each vaccination (vaccination 1 [at Month 0] and vaccination 2 [at Month 2])Population: The total vaccinated cohort (TVC) included all participants vaccinated with at least 1 dose of study vaccine. The analysis was performed per vaccine actually administered at Dose 1. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure and 'number analyzed' signifies participants evaluable for each specified category.
Solicited local reactions included pain, redness and swelling. Here, '0' in the number analyzed field signifies that no vaccine was administered in the specified group for the specified category.
Outcome measures
| Measure |
ACWY1d Group
n=199 Participants
Participants received single dose of meningococcal polysaccharide groups A, C, W-135, and Y tetanus toxoid conjugate (MenACWY-TT) vaccine administered intramuscularly at Month 0.
|
ACWY2d Group
n=196 Participants
Participants received two doses of MenACWY-TT vaccine administered intramuscularly at Month 0 and Month 2.
|
Co-ad Group
n=197 Participants
Participants received single dose of MenACWY-TT vaccine and single dose of Prevnar 13 administered intramuscularly at Month 0.
|
PCV13 Group
n=197 Participants
Participants received single dose of Prevnar 13 at Month 0 and single dose of MenACWY-TT administered intramuscularly at Month 2.
|
|---|---|---|---|---|
|
Number of Participants With Solicited Local Reactions Within 4 Days Post Each Vaccination
Pain: Post MenACWY-TT Dose 1
|
52 Participants
|
64 Participants
|
72 Participants
|
—
|
|
Number of Participants With Solicited Local Reactions Within 4 Days Post Each Vaccination
Pain: Post Prevenar 13 Dose 1
|
—
|
—
|
85 Participants
|
72 Participants
|
|
Number of Participants With Solicited Local Reactions Within 4 Days Post Each Vaccination
Pain: Post MenACWY-TT Dose 2
|
—
|
58 Participants
|
—
|
53 Participants
|
|
Number of Participants With Solicited Local Reactions Within 4 Days Post Each Vaccination
Redness: Post MenACWY-TT Dose 1
|
68 Participants
|
73 Participants
|
73 Participants
|
—
|
|
Number of Participants With Solicited Local Reactions Within 4 Days Post Each Vaccination
Redness: Post Prevenar 13 Dose 1
|
—
|
—
|
87 Participants
|
90 Participants
|
|
Number of Participants With Solicited Local Reactions Within 4 Days Post Each Vaccination
Redness: Post MenACWY-TT Dose 2
|
—
|
64 Participants
|
—
|
66 Participants
|
|
Number of Participants With Solicited Local Reactions Within 4 Days Post Each Vaccination
Swelling: Post MenACWY-TT Dose 1
|
35 Participants
|
45 Participants
|
43 Participants
|
—
|
|
Number of Participants With Solicited Local Reactions Within 4 Days Post Each Vaccination
Swelling: Post Prevenar 13 Dose 1
|
—
|
—
|
69 Participants
|
63 Participants
|
|
Number of Participants With Solicited Local Reactions Within 4 Days Post Each Vaccination
Swelling: Post MenACWY-TT Dose 2
|
—
|
34 Participants
|
—
|
30 Participants
|
SECONDARY outcome
Timeframe: Within 4 days post each vaccination (vaccination 1 [Dose 1] and vaccination 2 [Dose 2])Population: The total vaccinated cohort (TVC) included all participants vaccinated with at least 1 dose of study vaccine. The analysis was performed per vaccine actually administered at Dose 1. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure and 'number analyzed' signifies participants evaluable for each specified category.
Solicited general reactions included drowsiness, irritability/fussiness, loss of appetite and fever. Here, '0' in the number analyzed field signifies that no vaccine was administered in the specified group for the specified category. Post dose 1 for ACWY1d and Co-ad group included reactions occurred after dosing of both MenACWY-TT and Prevenar 13 for Co-ad group and data was collected and summarized collectively.
Outcome measures
| Measure |
ACWY1d Group
n=199 Participants
Participants received single dose of meningococcal polysaccharide groups A, C, W-135, and Y tetanus toxoid conjugate (MenACWY-TT) vaccine administered intramuscularly at Month 0.
|
ACWY2d Group
n=196 Participants
Participants received two doses of MenACWY-TT vaccine administered intramuscularly at Month 0 and Month 2.
|
Co-ad Group
n=197 Participants
Participants received single dose of MenACWY-TT vaccine and single dose of Prevnar 13 administered intramuscularly at Month 0.
|
PCV13 Group
n=197 Participants
Participants received single dose of Prevnar 13 at Month 0 and single dose of MenACWY-TT administered intramuscularly at Month 2.
|
|---|---|---|---|---|
|
Number of Participants With Solicited General Reactions Within 4 Days Post Each Vaccination
Drowsiness: Post Dose 1
|
62 Participants
|
73 Participants
|
85 Participants
|
72 Participants
|
|
Number of Participants With Solicited General Reactions Within 4 Days Post Each Vaccination
Drowsiness: Post Dose 2
|
—
|
60 Participants
|
—
|
50 Participants
|
|
Number of Participants With Solicited General Reactions Within 4 Days Post Each Vaccination
Irritability/Fussiness: Post Dose 1
|
89 Participants
|
93 Participants
|
107 Participants
|
85 Participants
|
|
Number of Participants With Solicited General Reactions Within 4 Days Post Each Vaccination
Irritability/Fussiness: Post Dose 2
|
—
|
76 Participants
|
—
|
67 Participants
|
|
Number of Participants With Solicited General Reactions Within 4 Days Post Each Vaccination
Loss of Appetite: Post Dose 1
|
56 Participants
|
60 Participants
|
54 Participants
|
58 Participants
|
|
Number of Participants With Solicited General Reactions Within 4 Days Post Each Vaccination
Loss of Appetite: Post Dose 2
|
—
|
45 Participants
|
—
|
47 Participants
|
|
Number of Participants With Solicited General Reactions Within 4 Days Post Each Vaccination
Fever: Post Dose 1
|
26 Participants
|
25 Participants
|
34 Participants
|
43 Participants
|
|
Number of Participants With Solicited General Reactions Within 4 Days Post Each Vaccination
Fever: Post Dose 2
|
—
|
23 Participants
|
—
|
25 Participants
|
SECONDARY outcome
Timeframe: Within 31 days post any vaccinationPopulation: The total vaccinated cohort (TVC) included all participants vaccinated with at least 1 dose of study vaccine. The analysis was performed per vaccine actually administered at Dose 1.
An adverse event was any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An unsolicited adverse event was an observed adverse event that did not fulfill the conditions prelisted in the case report book (CRB) in terms of symptom and/or onset post-vaccination.
Outcome measures
| Measure |
ACWY1d Group
n=203 Participants
Participants received single dose of meningococcal polysaccharide groups A, C, W-135, and Y tetanus toxoid conjugate (MenACWY-TT) vaccine administered intramuscularly at Month 0.
|
ACWY2d Group
n=197 Participants
Participants received two doses of MenACWY-TT vaccine administered intramuscularly at Month 0 and Month 2.
|
Co-ad Group
n=201 Participants
Participants received single dose of MenACWY-TT vaccine and single dose of Prevnar 13 administered intramuscularly at Month 0.
|
PCV13 Group
n=201 Participants
Participants received single dose of Prevnar 13 at Month 0 and single dose of MenACWY-TT administered intramuscularly at Month 2.
|
|---|---|---|---|---|
|
Number of Participants With Unsolicited Adverse Events Within 31 Days Post Any Study Vaccination, Classified According to Medical Dictionary for Regulatory Activities (MedDRA)
|
11 Participants
|
15 Participants
|
11 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Month 0 to Month 9Population: The total vaccinated cohort (TVC) included all participants vaccinated with at least 1 dose of study vaccine. The analysis was performed per vaccine actually administered at Dose 1.
An adverse event was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect.
Outcome measures
| Measure |
ACWY1d Group
n=203 Participants
Participants received single dose of meningococcal polysaccharide groups A, C, W-135, and Y tetanus toxoid conjugate (MenACWY-TT) vaccine administered intramuscularly at Month 0.
|
ACWY2d Group
n=197 Participants
Participants received two doses of MenACWY-TT vaccine administered intramuscularly at Month 0 and Month 2.
|
Co-ad Group
n=201 Participants
Participants received single dose of MenACWY-TT vaccine and single dose of Prevnar 13 administered intramuscularly at Month 0.
|
PCV13 Group
n=201 Participants
Participants received single dose of Prevnar 13 at Month 0 and single dose of MenACWY-TT administered intramuscularly at Month 2.
|
|---|---|---|---|---|
|
Number of Participants With Serious Adverse Events From Month 0 to Month 9
|
8 Participants
|
6 Participants
|
10 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Baseline up to end of study (up to 5 years)Population: The total vaccinated cohort (TVC) included all participants vaccinated with at least 1 dose of study vaccine. The analysis was performed per vaccine actually administered at Dose 1.
An adverse event was any untoward medical occurrence in a participant who received study drug. Serious adverse event was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Related adverse events were those adverse events who were related to the vaccination as judged by the investigator.
Outcome measures
| Measure |
ACWY1d Group
n=203 Participants
Participants received single dose of meningococcal polysaccharide groups A, C, W-135, and Y tetanus toxoid conjugate (MenACWY-TT) vaccine administered intramuscularly at Month 0.
|
ACWY2d Group
n=197 Participants
Participants received two doses of MenACWY-TT vaccine administered intramuscularly at Month 0 and Month 2.
|
Co-ad Group
n=201 Participants
Participants received single dose of MenACWY-TT vaccine and single dose of Prevnar 13 administered intramuscularly at Month 0.
|
PCV13 Group
n=201 Participants
Participants received single dose of Prevnar 13 at Month 0 and single dose of MenACWY-TT administered intramuscularly at Month 2.
|
|---|---|---|---|---|
|
Number of Participants With Serious Adverse Events Related to Study Vaccination From First Dose of Study Drug up to End of Study
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Month 0 to Month 9Population: The total vaccinated cohort (TVC) included all participants vaccinated with at least 1 dose of study vaccine. The analysis was performed per vaccine actually administered at Dose 1.
New onset chronic illness included autoimmune disorders, asthma, type I diabetes and allergies.
Outcome measures
| Measure |
ACWY1d Group
n=203 Participants
Participants received single dose of meningococcal polysaccharide groups A, C, W-135, and Y tetanus toxoid conjugate (MenACWY-TT) vaccine administered intramuscularly at Month 0.
|
ACWY2d Group
n=197 Participants
Participants received two doses of MenACWY-TT vaccine administered intramuscularly at Month 0 and Month 2.
|
Co-ad Group
n=201 Participants
Participants received single dose of MenACWY-TT vaccine and single dose of Prevnar 13 administered intramuscularly at Month 0.
|
PCV13 Group
n=201 Participants
Participants received single dose of Prevnar 13 at Month 0 and single dose of MenACWY-TT administered intramuscularly at Month 2.
|
|---|---|---|---|---|
|
Number of Participants With Any New Onset of Chronic Illnesses (NOCIs) From Month 0 to Month 9
|
2 Participants
|
3 Participants
|
1 Participants
|
5 Participants
|
Adverse Events
ACWY1d Group
Serious events: 12 serious events
Other events: 199 other events
Deaths: 0 deaths
ACWY2d Group
Serious events: 11 serious events
Other events: 196 other events
Deaths: 0 deaths
Co-ad Group
Serious events: 13 serious events
Other events: 197 other events
Deaths: 1 deaths
PCV13 Group
Serious events: 16 serious events
Other events: 197 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
ACWY1d Group
n=203 participants at risk
Participants received single dose of meningococcal polysaccharide groups A, C, W-135, and Y tetanus toxoid conjugate (MenACWY-TT) vaccine administered intramuscularly at Month 0.
|
ACWY2d Group
n=197 participants at risk
Participants received two doses of MenACWY-TT vaccine administered intramuscularly at Month 0 and Month 2.
|
Co-ad Group
n=201 participants at risk
Participants received single dose of MenACWY-TT vaccine and single dose of Prevnar 13 administered intramuscularly at Month 0.
|
PCV13 Group
n=201 participants at risk
Participants received single dose of Prevnar 13 at Month 0 and single dose of MenACWY-TT administered intramuscularly at Month 2.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.50%
1/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.51%
1/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.51%
1/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.50%
1/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Immune system disorders
Anaphylactic shock
|
0.49%
1/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.50%
1/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Bronchiolitis
|
0.49%
1/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.0%
2/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.50%
1/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Bronchitis
|
0.49%
1/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.00%
2/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Bronchitis viral
|
0.49%
1/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Croup infectious
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.50%
1/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Encephalitis
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.50%
1/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.0%
2/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.50%
1/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Gastroenteritis rotavirus
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.50%
1/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Gastroenteritis salmonella
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.50%
1/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Laryngitis
|
0.49%
1/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.51%
1/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Meningitis aseptic
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.50%
1/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Myringitis
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.51%
1/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.51%
1/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Otitis media
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.51%
1/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.50%
1/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Pneumonia
|
0.49%
1/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.5%
3/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.5%
3/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.50%
1/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.49%
1/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Pneumonia viral
|
0.49%
1/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Staphylococcal scalded skin syndrome
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.50%
1/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.51%
1/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.00%
2/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.5%
3/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Burns first degree
|
0.49%
1/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.49%
1/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.49%
1/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.51%
1/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Petroleum distillate poisoning
|
0.49%
1/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.51%
1/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.50%
1/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.50%
1/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.50%
1/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.50%
1/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.50%
1/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Marasmus
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.50%
1/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.50%
1/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Febrile convulsion
|
0.49%
1/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Seizure
|
0.49%
1/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Adenoidal hypertrophy
|
0.49%
1/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Asphyxia
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.50%
1/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.50%
1/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.51%
1/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.50%
1/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.50%
1/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.51%
1/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.00%
2/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.50%
1/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
Other adverse events
| Measure |
ACWY1d Group
n=203 participants at risk
Participants received single dose of meningococcal polysaccharide groups A, C, W-135, and Y tetanus toxoid conjugate (MenACWY-TT) vaccine administered intramuscularly at Month 0.
|
ACWY2d Group
n=197 participants at risk
Participants received two doses of MenACWY-TT vaccine administered intramuscularly at Month 0 and Month 2.
|
Co-ad Group
n=201 participants at risk
Participants received single dose of MenACWY-TT vaccine and single dose of Prevnar 13 administered intramuscularly at Month 0.
|
PCV13 Group
n=201 participants at risk
Participants received single dose of Prevnar 13 at Month 0 and single dose of MenACWY-TT administered intramuscularly at Month 2.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Toothache
|
0.49%
1/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.51%
1/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Vomiting
|
3.0%
6/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.6%
17/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.0%
4/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
3.5%
7/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Crying
|
0.49%
1/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.49%
1/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.50%
1/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Ear and labyrinth disorders
Ear disorder
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.51%
1/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Eye disorders
Corneal erosion
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.50%
1/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Eye disorders
Eye inflammation
|
0.49%
1/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.51%
1/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.51%
1/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.50%
1/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Abnormal faeces
|
0.49%
1/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.49%
1/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.51%
1/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.50%
1/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Coeliac disease
|
0.49%
1/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.51%
1/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.50%
1/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.4%
7/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
7.1%
14/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.5%
9/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
11.4%
23/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.51%
1/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.51%
1/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.50%
1/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Faeces soft
|
0.49%
1/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.50%
1/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.51%
1/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.51%
1/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Nausea
|
0.49%
1/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.51%
1/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.50%
1/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.51%
1/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.00%
2/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Teething
|
3.4%
7/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
7.1%
14/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.0%
12/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
9.0%
18/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Tooth disorder
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.50%
1/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Fatigue
|
0.49%
1/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.50%
1/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Gait disturbance
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.51%
1/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Influenza like illness
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.51%
1/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.00%
2/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Injection site bruising
|
0.49%
1/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Injection site mass
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.00%
2/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Malaise
|
0.49%
1/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Pyrexia
|
5.9%
12/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
9.6%
19/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.0%
12/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.5%
13/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Swelling face
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.51%
1/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Vaccination site bruising
|
0.49%
1/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.51%
1/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.50%
1/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.00%
2/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Vaccination site pain
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.50%
1/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Immune system disorders
Food allergy
|
0.49%
1/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.51%
1/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Immune system disorders
Hypersensitivity
|
0.49%
1/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Immune system disorders
Immunisation reaction
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.50%
1/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Bronchiolitis
|
0.49%
1/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.5%
3/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.00%
2/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
3.5%
7/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Bronchitis
|
0.99%
2/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.5%
3/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.50%
1/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.0%
4/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Conjunctivitis
|
0.99%
2/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.6%
9/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.0%
4/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.5%
9/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Coxsackie viral infection
|
0.49%
1/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.0%
2/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.50%
1/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Croup infectious
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.5%
3/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.00%
2/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.5%
3/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Cystitis
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.51%
1/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Dermatitis infected
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.50%
1/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Ear infection
|
0.49%
1/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
3.0%
6/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.50%
1/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.5%
3/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Erythema infectiosum
|
0.49%
1/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.51%
1/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Exanthema subitum
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.00%
2/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Eye infection
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.51%
1/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Eyelid infection
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.50%
1/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Fungal infection
|
0.49%
1/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.0%
2/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Gastroenteritis
|
0.49%
1/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.0%
4/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.00%
2/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
3.0%
6/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Gastrointestinal bacterial infection
|
0.49%
1/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
0.49%
1/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.0%
4/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
3.0%
6/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.0%
4/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Herpangina
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.51%
1/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.50%
1/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Impetigo
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.0%
2/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.50%
1/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Infected bite
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.50%
1/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Influenza
|
0.49%
1/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.0%
4/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.00%
2/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Laryngitis
|
0.49%
1/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.51%
1/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.50%
1/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.00%
2/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.49%
1/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.51%
1/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.00%
2/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Measles
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.50%
1/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Nasopharyngitis
|
4.4%
9/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.6%
17/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.5%
11/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
7.5%
15/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.50%
1/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Otitis media
|
1.5%
3/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.1%
8/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.0%
4/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.5%
11/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.50%
1/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Otosalpingitis
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.51%
1/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Periodontitis
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.51%
1/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Periorbital cellulitis
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.50%
1/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Pharyngitis
|
1.5%
3/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.5%
3/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.00%
2/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.00%
2/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Pharyngotonsillitis
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.50%
1/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Pneumonia
|
0.49%
1/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.00%
2/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.50%
1/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.49%
1/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Respiratory tract infection
|
0.49%
1/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.51%
1/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Rhinitis
|
2.0%
4/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.5%
5/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.5%
3/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.0%
4/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Roseola
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.00%
2/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Sinusitis
|
0.49%
1/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Skin bacterial infection
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.50%
1/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.51%
1/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Tinea infection
|
0.49%
1/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Tinea versicolour
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.50%
1/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Tonsillitis
|
0.99%
2/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.5%
5/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.50%
1/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.00%
2/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.9%
12/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.2%
28/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
7.5%
15/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
11.9%
24/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Urinary tract infection
|
0.49%
1/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Varicella
|
0.99%
2/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.0%
4/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.50%
1/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.00%
2/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Viral infection
|
3.0%
6/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.1%
12/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.0%
4/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
3.5%
7/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Viral rash
|
0.49%
1/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.0%
2/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.50%
1/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.50%
1/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
1.5%
3/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.0%
4/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.50%
1/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.50%
1/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.50%
1/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.50%
1/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.0%
2/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.0%
2/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.51%
1/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.51%
1/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.49%
1/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.51%
1/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.50%
1/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.51%
1/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.49%
1/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.50%
1/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.51%
1/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.50%
1/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Body temperature
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.51%
1/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Body temperature increased
|
0.49%
1/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.51%
1/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.00%
2/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.5%
3/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.0%
4/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.50%
1/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.50%
1/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Polydipsia
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.51%
1/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.50%
1/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.50%
1/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Febrile convulsion
|
1.5%
3/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.51%
1/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.50%
1/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Poor quality sleep
|
0.49%
1/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Seizure
|
0.49%
1/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.50%
1/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.50%
1/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Psychiatric disorders
Autism spectrum disorder
|
0.49%
1/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Psychiatric disorders
Fear
|
0.49%
1/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Psychiatric disorders
Initial insomnia
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.50%
1/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Psychiatric disorders
Insomnia
|
0.49%
1/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
3.0%
6/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.5%
5/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.5%
3/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.5%
3/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Reproductive system and breast disorders
Balanoposthitis
|
0.49%
1/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Reproductive system and breast disorders
Genital labial adhesions
|
0.49%
1/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.51%
1/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Reproductive system and breast disorders
Genital rash
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.50%
1/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Reproductive system and breast disorders
Vulvovaginal adhesion
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.50%
1/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.50%
1/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.99%
2/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.0%
2/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.50%
1/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Catarrh
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.50%
1/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.4%
13/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
10.7%
21/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.0%
8/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.0%
12/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.50%
1/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.0%
4/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.00%
2/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
3.0%
6/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal disorder
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.51%
1/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal mucosal discolouration
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.50%
1/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.51%
1/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.00%
2/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.51%
1/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory symptom
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.50%
1/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
3.0%
6/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
3.6%
7/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
3.0%
6/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
3.5%
7/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.00%
2/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.51%
1/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.00%
2/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.00%
2/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.5%
5/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.5%
5/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.49%
1/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.0%
4/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.5%
5/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Intertrigo
|
0.49%
1/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.51%
1/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.50%
1/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.5%
5/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.6%
9/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.5%
5/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.0%
4/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.51%
1/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.00%
2/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.49%
1/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.00%
2/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.51%
1/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Rash morbilliform
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.50%
1/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.50%
1/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/203 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.50%
1/201 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Pain
|
26.1%
52/199 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
46.4%
91/196 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
47.7%
94/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
46.2%
91/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Redness
|
34.2%
68/199 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
44.9%
88/196 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
47.7%
94/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
54.8%
108/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Swelling
|
17.6%
35/199 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
29.1%
57/196 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
38.1%
75/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
37.1%
73/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Drowsiness
|
31.2%
62/199 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
50.5%
99/196 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
43.1%
85/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
45.2%
89/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Irritability/Fussiness
|
44.7%
89/199 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
59.2%
116/196 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
54.3%
107/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
54.8%
108/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Loss Of Appetite
|
28.1%
56/199 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
39.8%
78/196 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
27.4%
54/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
42.1%
83/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Temperature/(Rectal) (°C)
|
13.1%
26/199 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
23.5%
46/196 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
17.3%
34/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
32.0%
63/197 • AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER