Trial Outcomes & Findings for Study to Evaluate 13 Valent Pneumococcal Conjugate Vaccine (13vPnC) Vaccine Followed by 23-valent Pneumococcal Polysaccharide Vaccine (23vPS) Vaccine in Allogeneic Hematopoietic Stem Cell Transplant Recipients (NCT NCT00980655)
NCT ID: NCT00980655
Last Updated: 2018-12-20
Results Overview
GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from before 13vPnC Dose 1 to 1 month after 13vPnC Dose 3 were computed using the logarithmically transformed assay results. Confidence interval (CI) for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both before 13vPnC Dose 1 and after 13vPnC Dose 3 blood draws.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
251 participants
Primary outcome timeframe
Before 13vPnC Dose 1 (pre-vaccination), 1 month after 13vPnC Dose 3
Results posted on
2018-12-20
Participant Flow
Participant milestones
| Measure |
13vPnC, 23vPS (Pediatric Participants)
Pediatric participants aged 2 to 17 years received 4 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injections followed by single 0.5 mL dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
|
13vPnC, 23vPS (Adult Participants)
Adult participants aged 18 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
|
|---|---|---|
|
Overall Study
STARTED
|
61
|
190
|
|
Overall Study
Vaccinated 13vPnC Dose 1
|
59
|
188
|
|
Overall Study
Vaccinated 13vPnC Dose 2
|
55
|
176
|
|
Overall Study
Vaccinated 13vPnC Dose 3
|
54
|
167
|
|
Overall Study
Vaccinated 13vPnC Dose 4
|
46
|
146
|
|
Overall Study
Vaccinated 23vPS Dose
|
45
|
140
|
|
Overall Study
COMPLETED
|
45
|
139
|
|
Overall Study
NOT COMPLETED
|
16
|
51
|
Reasons for withdrawal
| Measure |
13vPnC, 23vPS (Pediatric Participants)
Pediatric participants aged 2 to 17 years received 4 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injections followed by single 0.5 mL dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
|
13vPnC, 23vPS (Adult Participants)
Adult participants aged 18 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
|
|---|---|---|
|
Overall Study
Adverse Event
|
13
|
31
|
|
Overall Study
Death
|
0
|
7
|
|
Overall Study
Protocol Violation
|
2
|
7
|
|
Overall Study
Withdrawal by Subject
|
0
|
4
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Parent/legal guardian request
|
1
|
0
|
|
Overall Study
Other
|
0
|
1
|
Baseline Characteristics
Study to Evaluate 13 Valent Pneumococcal Conjugate Vaccine (13vPnC) Vaccine Followed by 23-valent Pneumococcal Polysaccharide Vaccine (23vPS) Vaccine in Allogeneic Hematopoietic Stem Cell Transplant Recipients
Baseline characteristics by cohort
| Measure |
13vPnC, 23vPS (Pediatric Participants)
n=59 Participants
Pediatric participants aged 2 to 17 years received 4 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injections followed by single 0.5 mL dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
|
13vPnC, 23vPS (Adult Participants)
n=188 Participants
Adult participants aged 18 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
|
Total
n=247 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
10.3 years
STANDARD_DEVIATION 4.41 • n=5 Participants
|
47.3 years
STANDARD_DEVIATION 12.39 • n=7 Participants
|
38.4 years
STANDARD_DEVIATION 19.26 • n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
114 Participants
n=7 Participants
|
147 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Before 13vPnC Dose 1 (pre-vaccination), 1 month after 13vPnC Dose 3Population: Evaluable immunogenicity population:eligible participants who received vaccination as assigned;had blood drawn within pre-specified time-frames;had at least 1 valid, determinate assay result; had no major protocol violation. N (number of participants analyzed)=participants evaluable for this measure, n=participants evaluable for specified serotype.
GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from before 13vPnC Dose 1 to 1 month after 13vPnC Dose 3 were computed using the logarithmically transformed assay results. Confidence interval (CI) for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both before 13vPnC Dose 1 and after 13vPnC Dose 3 blood draws.
Outcome measures
| Measure |
13vPnC, 23vPS (All Participants)
n=197 Participants
All participants aged 2 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
|
13vPnC, 23vPS (Adult Participants)
Adult participants aged 18 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
|
13vPnC, 23vPS (All Participants)
All participants aged 2 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
|
|---|---|---|---|
|
Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 3 in All Participants
Serotype 1 (n=191)
|
17.96 fold rise
Interval 13.63 to 23.66
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 3 in All Participants
Serotype 3 (n=192)
|
5.07 fold rise
Interval 3.98 to 6.46
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 3 in All Participants
Serotype 4 (n=193)
|
23.85 fold rise
Interval 17.61 to 32.3
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 3 in All Participants
Serotype 5 (n=194)
|
2.99 fold rise
Interval 2.46 to 3.63
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 3 in All Participants
Serotype 6A (n=195)
|
5.35 fold rise
Interval 4.18 to 6.85
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 3 in All Participants
Serotype 6B (n=192)
|
5.18 fold rise
Interval 3.99 to 6.74
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 3 in All Participants
Serotype 7F (n=195)
|
10.28 fold rise
Interval 8.15 to 12.96
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 3 in All Participants
Serotype 9V (n=196)
|
5.76 fold rise
Interval 4.63 to 7.17
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 3 in All Participants
Serotype 14 (n=197)
|
4.95 fold rise
Interval 3.72 to 6.58
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 3 in All Participants
Serotype 18C (n=196)
|
8.22 fold rise
Interval 6.36 to 10.62
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 3 in All Participants
Serotype 19A (n=196)
|
3.90 fold rise
Interval 3.1 to 4.89
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 3 in All Participants
Serotype 19F (n=195)
|
6.73 fold rise
Interval 5.15 to 8.78
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 3 in All Participants
Serotype 23F (n=197)
|
8.01 fold rise
Interval 6.11 to 10.51
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 month after 13vPnC Dose 3Population: Evaluable immunogenicity population. Here 'N' (number of participants analyzed) signifies all participants who were evaluable for this measure and 'n' signifies all participants who were evaluable for specified serotype for each treatment arm, respectively.
Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for pediatric, adult and all participants are presented. GMC (13vPnC) and corresponding 2-sided 95 percent (%) CIs were evaluated. Geometric means were calculated using all participants with available data for 1 month after 13vPnC Dose 3 blood draw. CI for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Outcome measures
| Measure |
13vPnC, 23vPS (All Participants)
n=49 Participants
All participants aged 2 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
|
13vPnC, 23vPS (Adult Participants)
n=149 Participants
Adult participants aged 18 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
|
13vPnC, 23vPS (All Participants)
n=198 Participants
All participants aged 2 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
|
|---|---|---|---|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 in Pediatric, Adult and All Participants
Serotype 1 (n=49, 147, 196)
|
3.52 microgram per milliliter (mcg/mL)
Interval 2.38 to 5.19
|
2.05 microgram per milliliter (mcg/mL)
Interval 1.53 to 2.76
|
2.35 microgram per milliliter (mcg/mL)
Interval 1.84 to 2.99
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 in Pediatric, Adult and All Participants
Serotype 3 (n=49, 147, 196)
|
1.60 microgram per milliliter (mcg/mL)
Interval 1.13 to 2.26
|
0.62 microgram per milliliter (mcg/mL)
Interval 0.49 to 0.79
|
0.79 microgram per milliliter (mcg/mL)
Interval 0.64 to 0.97
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 in Pediatric, Adult and All Participants
Serotype 4 (n=49, 147, 196)
|
4.13 microgram per milliliter (mcg/mL)
Interval 2.68 to 6.36
|
1.78 microgram per milliliter (mcg/mL)
Interval 1.35 to 2.34
|
2.20 microgram per milliliter (mcg/mL)
Interval 1.73 to 2.78
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 in Pediatric, Adult and All Participants
Serotype 5 (n=48, 149, 197)
|
4.18 microgram per milliliter (mcg/mL)
Interval 2.95 to 5.91
|
2.00 microgram per milliliter (mcg/mL)
Interval 1.6 to 2.51
|
2.39 microgram per milliliter (mcg/mL)
Interval 1.97 to 2.91
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 in Pediatric, Adult and All Participants
Serotype 6A (n=49, 148, 197)
|
7.61 microgram per milliliter (mcg/mL)
Interval 5.16 to 11.23
|
3.31 microgram per milliliter (mcg/mL)
Interval 2.53 to 4.33
|
4.07 microgram per milliliter (mcg/mL)
Interval 3.25 to 5.11
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 in Pediatric, Adult and All Participants
Serotype 6B (n=48, 147, 195)
|
6.29 microgram per milliliter (mcg/mL)
Interval 3.88 to 10.19
|
3.00 microgram per milliliter (mcg/mL)
Interval 2.25 to 3.98
|
3.60 microgram per milliliter (mcg/mL)
Interval 2.81 to 4.61
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 in Pediatric, Adult and All Participants
Serotype 7F (n=48, 149, 197)
|
7.34 microgram per milliliter (mcg/mL)
Interval 5.12 to 10.53
|
3.92 microgram per milliliter (mcg/mL)
Interval 3.08 to 5.0
|
4.57 microgram per milliliter (mcg/mL)
Interval 3.72 to 5.61
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 in Pediatric, Adult and All Participants
Serotype 9V (n=49, 149, 198)
|
4.17 microgram per milliliter (mcg/mL)
Interval 3.01 to 5.78
|
2.44 microgram per milliliter (mcg/mL)
Interval 1.93 to 3.1
|
2.79 microgram per milliliter (mcg/mL)
Interval 2.29 to 3.4
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 in Pediatric, Adult and All Participants
Serotype 14 (n=49, 149, 198)
|
6.22 microgram per milliliter (mcg/mL)
Interval 4.03 to 9.61
|
5.99 microgram per milliliter (mcg/mL)
Interval 4.35 to 8.26
|
6.05 microgram per milliliter (mcg/mL)
Interval 4.65 to 7.86
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 in Pediatric, Adult and All Participants
Serotype 18C (n=49, 148, 197)
|
4.17 microgram per milliliter (mcg/mL)
Interval 2.9 to 5.98
|
3.04 microgram per milliliter (mcg/mL)
Interval 2.37 to 3.91
|
3.29 microgram per milliliter (mcg/mL)
Interval 2.67 to 4.05
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 in Pediatric, Adult and All Participants
Serotype 19A (n=49, 148, 197)
|
8.26 microgram per milliliter (mcg/mL)
Interval 5.86 to 11.65
|
4.77 microgram per milliliter (mcg/mL)
Interval 3.77 to 6.04
|
5.47 microgram per milliliter (mcg/mL)
Interval 4.49 to 6.67
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 in Pediatric, Adult and All Participants
Serotype 19F (n=49, 148, 197)
|
5.80 microgram per milliliter (mcg/mL)
Interval 3.8 to 8.84
|
3.48 microgram per milliliter (mcg/mL)
Interval 2.69 to 4.5
|
3.95 microgram per milliliter (mcg/mL)
Interval 3.17 to 4.93
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 in Pediatric, Adult and All Participants
Serotype 23F (n=49, 149, 198)
|
6.74 microgram per milliliter (mcg/mL)
Interval 4.12 to 11.05
|
3.87 microgram per milliliter (mcg/mL)
Interval 2.85 to 5.26
|
4.44 microgram per milliliter (mcg/mL)
Interval 3.42 to 5.77
|
SECONDARY outcome
Timeframe: 1 month after 13vPnC Dose 4Population: Evaluable immunogenicity population. Here 'N' (number of participants analyzed) signifies all participants who were evaluable for this measure and 'n' signifies all participants who were evaluable for specified serotype for each treatment arm, respectively.
Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for pediatric, adult and all participants are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data for 1 month after 13vPnC Dose 4 blood draw. CI for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Outcome measures
| Measure |
13vPnC, 23vPS (All Participants)
n=38 Participants
All participants aged 2 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
|
13vPnC, 23vPS (Adult Participants)
n=124 Participants
Adult participants aged 18 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
|
13vPnC, 23vPS (All Participants)
n=162 Participants
All participants aged 2 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
|
|---|---|---|---|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants
Serotype 14 (n=37, 124, 161)
|
16.04 mcg/mL
Interval 10.04 to 25.63
|
12.24 mcg/mL
Interval 9.09 to 16.47
|
13.02 mcg/mL
Interval 10.13 to 16.74
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants
Serotype 18C (n=38, 122, 160)
|
6.54 mcg/mL
Interval 4.04 to 10.59
|
6.69 mcg/mL
Interval 5.01 to 8.93
|
6.65 mcg/mL
Interval 5.2 to 8.51
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants
Serotype 9V (n=37, 124, 161)
|
7.78 mcg/mL
Interval 5.21 to 11.61
|
5.09 mcg/mL
Interval 3.93 to 6.59
|
5.61 mcg/mL
Interval 4.5 to 6.98
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants
Serotype 19A (n=37, 124, 161)
|
16.94 mcg/mL
Interval 11.05 to 25.98
|
12.99 mcg/mL
Interval 9.78 to 17.26
|
13.81 mcg/mL
Interval 10.88 to 17.52
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants
Serotype 19F (n=38, 123, 161)
|
19.96 mcg/mL
Interval 12.19 to 32.68
|
13.69 mcg/mL
Interval 9.93 to 18.88
|
14.96 mcg/mL
Interval 11.42 to 19.61
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants
Serotype 23F (n=38, 123, 161)
|
16.65 mcg/mL
Interval 10.73 to 25.82
|
12.68 mcg/mL
Interval 8.82 to 18.22
|
13.52 mcg/mL
Interval 10.07 to 18.15
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants
Serotype 1 (n=38, 123, 161)
|
8.75 mcg/mL
Interval 5.64 to 13.59
|
4.67 mcg/mL
Interval 3.37 to 6.47
|
5.41 mcg/mL
Interval 4.13 to 7.1
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants
Serotype 3 (n=38, 123, 161)
|
1.23 mcg/mL
Interval 0.89 to 1.7
|
0.91 mcg/mL
Interval 0.71 to 1.17
|
0.97 mcg/mL
Interval 0.79 to 1.2
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants
Serotype 4 (n=36, 124, 160)
|
8.41 mcg/mL
Interval 5.15 to 13.72
|
4.56 mcg/mL
Interval 3.31 to 6.27
|
5.23 mcg/mL
Interval 3.99 to 6.86
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants
Serotype 5 (n=38, 122, 160)
|
8.43 mcg/mL
Interval 6.07 to 11.7
|
5.57 mcg/mL
Interval 4.28 to 7.26
|
6.15 mcg/mL
Interval 4.95 to 7.64
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants
Serotype 6A (n=37, 122, 159)
|
16.33 mcg/mL
Interval 10.59 to 25.16
|
12.23 mcg/mL
Interval 8.81 to 16.98
|
13.08 mcg/mL
Interval 9.99 to 17.13
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants
Serotype 6B (n=38, 124, 162)
|
18.13 mcg/mL
Interval 11.15 to 29.47
|
12.13 mcg/mL
Interval 8.63 to 17.06
|
13.33 mcg/mL
Interval 10.04 to 17.7
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants
Serotype 7F (n=38, 124, 162)
|
10.37 mcg/mL
Interval 7.36 to 14.61
|
8.26 mcg/mL
Interval 6.33 to 10.78
|
8.71 mcg/mL
Interval 7.0 to 10.83
|
SECONDARY outcome
Timeframe: Before 13vPnC Dose 1 (pre-vaccination), 1 month after 13vPnC Dose 3Population: Evaluable immunogenicity population. Here 'N' (number of participants analyzed) signifies all participants who were evaluable for this measure and 'n' signifies all participants who were evaluable for specified serotype for each treatment arm, respectively.
GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from before 13vPnC Dose 1 to 1 month after 13vPnC Dose 3 were computed using the logarithmically transformed assay results. CI for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both before 13vPnC Dose 1 and after 13vPnC Dose 3 blood draws.
Outcome measures
| Measure |
13vPnC, 23vPS (All Participants)
n=49 Participants
All participants aged 2 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
|
13vPnC, 23vPS (Adult Participants)
n=148 Participants
Adult participants aged 18 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
|
13vPnC, 23vPS (All Participants)
All participants aged 2 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
|
|---|---|---|---|
|
Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 3 in Pediatric and Adult Participants
Serotype 1 (n=48, 143)
|
27.64 fold rise
Interval 16.75 to 45.62
|
15.54 fold rise
Interval 11.2 to 21.56
|
—
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 3 in Pediatric and Adult Participants
Serotype 3 (n=48, 144)
|
7.58 fold rise
Interval 4.74 to 12.13
|
4.43 fold rise
Interval 3.35 to 5.88
|
—
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 3 in Pediatric and Adult Participants
Serotype 4 (n=49, 144)
|
40.83 fold rise
Interval 23.84 to 69.95
|
19.86 fold rise
Interval 13.83 to 28.52
|
—
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 3 in Pediatric and Adult Participants
Serotype 5 (n=47, 147)
|
4.11 fold rise
Interval 2.86 to 5.9
|
2.70 fold rise
Interval 2.15 to 3.39
|
—
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 3 in Pediatric and Adult Participants
Serotype 6A (n=48, 147)
|
7.49 fold rise
Interval 4.79 to 11.72
|
4.79 fold rise
Interval 3.57 to 6.44
|
—
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 3 in Pediatric and Adult Participants
Serotype 6B (n=47, 145)
|
6.02 fold rise
Interval 3.79 to 9.55
|
4.94 fold rise
Interval 3.6 to 6.77
|
—
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 3 in Pediatric and Adult Participants
Serotype 7F (n=48, 147)
|
14.65 fold rise
Interval 9.63 to 22.28
|
9.15 fold rise
Interval 6.95 to 12.05
|
—
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 3 in Pediatric and Adult Participants
Serotype 9V (n=48, 148)
|
7.64 fold rise
Interval 5.4 to 10.82
|
5.26 fold rise
Interval 4.02 to 6.87
|
—
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 3 in Pediatric and Adult Participants
Serotype 14 (n=49, 148)
|
5.01 fold rise
Interval 2.83 to 8.86
|
4.92 fold rise
Interval 3.53 to 6.87
|
—
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 3 in Pediatric and Adult Participants
Serotype 18C (n=49, 147)
|
12.59 fold rise
Interval 7.84 to 20.21
|
7.13 fold rise
Interval 5.27 to 9.65
|
—
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 3 in Pediatric and Adult Participants
Serotype 19A (n=49, 147)
|
5.04 fold rise
Interval 3.38 to 7.51
|
3.58 fold rise
Interval 2.72 to 4.7
|
—
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 3 in Pediatric and Adult Participants
Serotype 19F (n=49, 146)
|
7.66 fold rise
Interval 4.67 to 12.57
|
6.44 fold rise
Interval 4.69 to 8.85
|
—
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 3 in Pediatric and Adult Participants
Serotype 23F (n=49, 148)
|
9.73 fold rise
Interval 5.79 to 16.34
|
7.52 fold rise
Interval 5.46 to 10.35
|
—
|
SECONDARY outcome
Timeframe: Before 13vPnC Dose 1 (pre-vaccination), 1 month after 13vPnC Dose 4Population: Evaluable immunogenicity population. Here 'N' (number of participants analyzed) signifies all participants who were evaluable for this measure and 'n' signifies all participants who were evaluable for specified serotype for each treatment arm, respectively.
GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from before 13vPnC Dose 1 to 1 month after 13vPnC Dose 4 were computed using the logarithmically transformed assay results. CI for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both before 13vPnC Dose 1 and after 13vPnC Dose 4 blood draws.
Outcome measures
| Measure |
13vPnC, 23vPS (All Participants)
n=38 Participants
All participants aged 2 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
|
13vPnC, 23vPS (Adult Participants)
n=123 Participants
Adult participants aged 18 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
|
13vPnC, 23vPS (All Participants)
n=161 Participants
All participants aged 2 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
|
|---|---|---|---|
|
Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants
Serotype 1 (n=37, 120, 157)
|
70.66 fold rise
Interval 39.2 to 127.36
|
35.81 fold rise
Interval 25.06 to 51.18
|
42.03 fold rise
Interval 30.94 to 57.11
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants
Serotype 3 (n=37, 120, 157)
|
5.88 fold rise
Interval 3.25 to 10.61
|
6.41 fold rise
Interval 4.74 to 8.66
|
6.28 fold rise
Interval 4.81 to 8.19
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants
Serotype 4 (n=36, 121, 157)
|
90.31 fold rise
Interval 48.05 to 169.77
|
47.47 fold rise
Interval 32.09 to 70.22
|
55.02 fold rise
Interval 39.39 to 76.85
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants
Serotype 5 (n=37, 119, 156)
|
7.76 fold rise
Interval 4.81 to 12.51
|
7.29 fold rise
Interval 5.32 to 9.99
|
7.40 fold rise
Interval 5.69 to 9.63
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants
Serotype 6A (n=36, 121, 157)
|
15.62 fold rise
Interval 9.63 to 25.34
|
17.02 fold rise
Interval 11.95 to 24.23
|
16.90 fold rise
Interval 12.47 to 22.34
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants
Serotype 6B (n=37, 122, 159)
|
16.90 fold rise
Interval 9.76 to 29.25
|
20.09 fold rise
Interval 13.94 to 28.94
|
19.29 fold rise
Interval 14.22 to 26.18
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants
Serotype 7F (n=38, 123, 161)
|
19.18 fold rise
Interval 11.75 to 31.33
|
18.69 fold rise
Interval 13.7 to 25.5
|
18.81 fold rise
Interval 14.48 to 24.43
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants
Serotype 9V (n=36, 122, 158)
|
14.90 fold rise
Interval 9.55 to 23.25
|
11.13 fold rise
Interval 8.27 to 14.99
|
11.90 fold rise
Interval 9.27 to 15.27
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants
Serotype 14 (n=37, 123, 160)
|
12.61 fold rise
Interval 6.47 to 24.56
|
9.69 fold rise
Interval 6.8 to 13.8
|
10.30 fold rise
Interval 7.55 to 14.03
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants
Serotype 18C (n=38, 121, 159)
|
21.22 fold rise
Interval 12.05 to 37.36
|
14.40 fold rise
Interval 10.17 to 20.41
|
15.80 fold rise
Interval 11.76 to 21.24
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants
Serotype 19A (n=37, 123, 160)
|
11.46 fold rise
Interval 7.22 to 18.2
|
9.52 fold rise
Interval 6.9 to 13.12
|
9.94 fold rise
Interval 7.61 to 12.98
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants
Serotype 19F (n=38, 120, 158)
|
29.31 fold rise
Interval 16.63 to 51.64
|
25.63 fold rise
Interval 17.56 to 37.43
|
26.47 fold rise
Interval 19.31 to 36.29
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants
Serotype 23F (n=38, 122, 160)
|
25.37 fold rise
Interval 14.69 to 43.83
|
23.02 fold rise
Interval 15.63 to 33.92
|
23.56 fold rise
Interval 17.11 to 32.45
|
SECONDARY outcome
Timeframe: 1 month after 13vPnC Dose 3, 1 month after 13vPnC Dose 4Population: Evaluable immunogenicity population. Here 'N' (number of participants analyzed) signifies all participants who were evaluable for this measure and 'n' signifies all participants who were evaluable for specified serotype for each treatment arm, respectively.
GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month after 13vPnC Dose 3 to 1 month after 13vPnC Dose 4 were computed using the logarithmically transformed assay results. CI for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both after 13vPnC Dose 3 and after 13vPnC Dose 4 blood draws.
Outcome measures
| Measure |
13vPnC, 23vPS (All Participants)
n=37 Participants
All participants aged 2 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
|
13vPnC, 23vPS (Adult Participants)
n=121 Participants
Adult participants aged 18 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
|
13vPnC, 23vPS (All Participants)
n=157 Participants
All participants aged 2 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
|
|---|---|---|---|
|
Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 3 to 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants
Serotype 1 (n=37, 119, 156)
|
2.80 fold rise
Interval 1.99 to 3.95
|
2.16 fold rise
Interval 1.65 to 2.82
|
2.30 fold rise
Interval 1.85 to 2.86
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 3 to 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants
Serotype 3 (n=37, 119, 156)
|
0.88 fold rise
Interval 0.64 to 1.22
|
1.32 fold rise
Interval 1.07 to 1.62
|
1.20 fold rise
Interval 1.01 to 1.43
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 3 to 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants
Serotype 4 (n=35, 121, 156)
|
2.19 fold rise
Interval 1.51 to 3.19
|
2.32 fold rise
Interval 1.88 to 2.86
|
2.29 fold rise
Interval 1.91 to 2.74
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 3 to 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants
Serotype 5 (n=37, 119, 156)
|
2.25 fold rise
Interval 1.74 to 2.93
|
2.43 fold rise
Interval 1.94 to 3.06
|
2.39 fold rise
Interval 1.99 to 2.87
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 3 to 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants
Serotype 6A (n=36, 119, 155)
|
2.36 fold rise
Interval 1.87 to 2.99
|
3.06 fold rise
Interval 2.35 to 3.98
|
2.88 fold rise
Interval 2.34 to 3.55
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 3 to 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants
Serotype 6B (n=37, 120, 157)
|
2.96 fold rise
Interval 2.09 to 4.19
|
3.10 fold rise
Interval 2.44 to 3.95
|
3.07 fold rise
Interval 2.51 to 3.75
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 3 to 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants
Serotype 7F (n=36, 121, 157)
|
1.51 fold rise
Interval 1.08 to 2.11
|
1.83 fold rise
Interval 1.47 to 2.29
|
1.75 fold rise
Interval 1.46 to 2.11
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 3 to 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants
Serotype 9V (n=36, 121, 157)
|
2.08 fold rise
Interval 1.43 to 3.03
|
1.82 fold rise
Interval 1.48 to 2.23
|
1.88 fold rise
Interval 1.57 to 2.24
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 3 to 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants
Serotype 14 (n=36, 121, 157)
|
2.50 fold rise
Interval 1.65 to 3.8
|
1.68 fold rise
Interval 1.32 to 2.13
|
1.84 fold rise
Interval 1.5 to 2.26
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 3 to 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants
Serotype 18C (n=37, 118, 155)
|
1.64 fold rise
Interval 1.24 to 2.16
|
1.87 fold rise
Interval 1.54 to 2.28
|
1.81 fold rise
Interval 1.54 to 2.13
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 3 to 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants
Serotype 23F (n=37, 120, 157)
|
2.49 fold rise
Interval 1.72 to 3.61
|
2.59 fold rise
Interval 2.04 to 3.3
|
2.57 fold rise
Interval 2.1 to 3.14
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 3 to 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants
Serotype 19A (n=36, 121, 157)
|
2.25 fold rise
Interval 1.6 to 3.17
|
2.33 fold rise
Interval 1.91 to 2.85
|
2.31 fold rise
Interval 1.95 to 2.74
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 3 to 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants
Serotype 19F (n=37, 120, 157)
|
3.50 fold rise
Interval 2.15 to 5.68
|
3.65 fold rise
Interval 2.9 to 4.59
|
3.61 fold rise
Interval 2.94 to 4.44
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Within 14 days after 13vPnC Dose 1Population: Safety population. Here 'N' (number of participants analyzed) signifies participants with known values for any local reaction and 'n' signifies participants with known values for specified local reaction. Participants may be represented in more than 1 category.
Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling were scaled as Any (redness present or swelling present); Mild (0.5 to 2.0 centimeters \[cm\] for participants aged 2 to \<12 years and 2.5 to 5.0 cm for participants aged \>= 12 years); Moderate (2.5 to 7.0 cm for participants aged 2 to \<12 years and 5.5 to 10.0 cm for participants aged \>= 12 years); Severe (greater than \[\>\] 7.0 cm for participants aged 2 to \<12 years and \>10.0 cm for participants aged \>= 12 years). Pain at injection site was scaled as Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity).
Outcome measures
| Measure |
13vPnC, 23vPS (All Participants)
n=52 Participants
All participants aged 2 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
|
13vPnC, 23vPS (Adult Participants)
n=171 Participants
Adult participants aged 18 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
|
13vPnC, 23vPS (All Participants)
n=223 Participants
All participants aged 2 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
|
|---|---|---|---|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 1
Redness: any (n = 38, 130, 168)
|
21.1 percentage of participants
Interval 9.6 to 37.3
|
11.5 percentage of participants
Interval 6.6 to 18.3
|
13.7 percentage of participants
Interval 8.9 to 19.8
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 1
Redness: mild (n = 38, 130, 168)
|
15.8 percentage of participants
Interval 6.0 to 31.3
|
10.8 percentage of participants
Interval 6.0 to 17.4
|
11.9 percentage of participants
Interval 7.4 to 17.8
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 1
Redness: moderate (n = 37, 128, 165)
|
10.8 percentage of participants
Interval 3.0 to 25.4
|
1.6 percentage of participants
Interval 0.2 to 5.5
|
3.6 percentage of participants
Interval 1.3 to 7.7
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 1
Swelling: any (n = 40, 130, 170)
|
25.0 percentage of participants
Interval 12.7 to 41.2
|
11.5 percentage of participants
Interval 6.6 to 18.3
|
14.7 percentage of participants
Interval 9.7 to 20.9
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 1
Swelling: mild (n = 39, 130, 169)
|
10.3 percentage of participants
Interval 2.9 to 24.2
|
10.8 percentage of participants
Interval 6.0 to 17.4
|
10.7 percentage of participants
Interval 6.4 to 16.3
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 1
Swelling: severe (n = 37, 128, 165)
|
0.0 percentage of participants
Interval 0.0 to 9.5
|
0.8 percentage of participants
Interval 0.0 to 4.3
|
0.6 percentage of participants
Interval 0.0 to 3.3
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 1
Pain: any (n = 51, 171, 222)
|
78.4 percentage of participants
Interval 64.7 to 88.7
|
73.1 percentage of participants
Interval 65.8 to 79.6
|
74.3 percentage of participants
Interval 68.1 to 79.9
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 1
Pain: moderate (n = 42, 138, 180)
|
45.2 percentage of participants
Interval 29.8 to 61.3
|
22.5 percentage of participants
Interval 15.8 to 30.3
|
27.8 percentage of participants
Interval 21.4 to 34.9
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 1
Pain: severe (n = 37, 129, 166)
|
5.4 percentage of participants
Interval 0.7 to 18.2
|
2.3 percentage of participants
Interval 0.5 to 6.6
|
3.0 percentage of participants
Interval 1.0 to 6.9
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 1
Redness: severe (n = 37, 128, 165)
|
0.0 percentage of participants
Interval 0.0 to 9.5
|
0.0 percentage of participants
Interval 0.0 to 2.8
|
0.0 percentage of participants
Interval 0.0 to 2.2
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 1
Swelling: moderate (n = 39, 128, 167)
|
20.5 percentage of participants
Interval 9.3 to 36.5
|
0.8 percentage of participants
Interval 0.0 to 4.3
|
5.4 percentage of participants
Interval 2.5 to 10.0
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 1
Pain: mild (n = 48, 169, 217)
|
68.8 percentage of participants
Interval 53.7 to 81.3
|
69.8 percentage of participants
Interval 62.3 to 76.6
|
69.6 percentage of participants
Interval 63.0 to 75.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Within 14 days after 13vPnC Dose 2Population: Safety population. Here 'N' (number of participants analyzed) signifies participants with known values for any local reaction and 'n' signifies participants with known values for specified local reaction. Participants may be represented in more than 1 category.
Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling were scaled as Any (redness present or swelling present); Mild (0.5 to 2.0 centimeters \[cm\] for participants aged 2 to \<12 years and 2.5 to 5.0 cm for participants aged \>= 12 years); Moderate (2.5 to 7.0 cm for participants aged 2 to \<12 years and 5.5 to 10.0 cm for participants aged \>= 12 years); Severe (greater than \[\>\] 7.0 cm for participants aged 2 to \<12 years and \>10.0 cm for participants aged \>= 12 years). Pain at injection site was scaled as Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity).
Outcome measures
| Measure |
13vPnC, 23vPS (All Participants)
n=41 Participants
All participants aged 2 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
|
13vPnC, 23vPS (Adult Participants)
n=157 Participants
Adult participants aged 18 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
|
13vPnC, 23vPS (All Participants)
n=198 Participants
All participants aged 2 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
|
|---|---|---|---|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 2
Redness: any (n = 28, 109, 137)
|
42.9 percentage of participants
Interval 24.5 to 62.8
|
16.5 percentage of participants
Interval 10.1 to 24.8
|
21.9 percentage of participants
Interval 15.3 to 29.8
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 2
Redness: mild (n = 26, 108, 134)
|
34.6 percentage of participants
Interval 17.2 to 55.7
|
15.7 percentage of participants
Interval 9.4 to 24.0
|
19.4 percentage of participants
Interval 13.1 to 27.1
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 2
Redness: moderate (n = 26, 103, 129)
|
26.9 percentage of participants
Interval 11.6 to 47.8
|
1.9 percentage of participants
Interval 0.2 to 6.8
|
7.0 percentage of participants
Interval 3.2 to 12.8
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 2
Redness: severe (n = 24, 103, 127)
|
4.2 percentage of participants
Interval 0.1 to 21.1
|
1.0 percentage of participants
Interval 0.0 to 5.3
|
1.6 percentage of participants
Interval 0.2 to 5.6
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 2
Swelling: any (n = 28, 105, 133)
|
35.7 percentage of participants
Interval 18.6 to 55.9
|
14.3 percentage of participants
Interval 8.2 to 22.5
|
18.8 percentage of participants
Interval 12.5 to 26.5
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 2
Swelling: mild (n = 26, 105, 131)
|
15.4 percentage of participants
Interval 4.4 to 34.9
|
14.3 percentage of participants
Interval 8.2 to 22.5
|
14.5 percentage of participants
Interval 9.0 to 21.7
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 2
Swelling: moderate (n = 26, 102, 128)
|
26.9 percentage of participants
Interval 11.6 to 47.8
|
0.0 percentage of participants
Interval 0.0 to 3.6
|
5.5 percentage of participants
Interval 2.2 to 10.9
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 2
Swelling: severe (n = 24, 102, 126)
|
0.0 percentage of participants
Interval 0.0 to 14.2
|
0.0 percentage of participants
Interval 0.0 to 3.6
|
0.0 percentage of participants
Interval 0.0 to 2.9
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 2
Pain: mild (n = 36, 148, 184)
|
66.7 percentage of participants
Interval 49.0 to 81.4
|
70.9 percentage of participants
Interval 62.9 to 78.1
|
70.1 percentage of participants
Interval 62.9 to 76.6
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 2
Pain: any (n = 40, 154, 194)
|
77.5 percentage of participants
Interval 61.5 to 89.2
|
74.7 percentage of participants
Interval 67.0 to 81.3
|
75.3 percentage of participants
Interval 68.6 to 81.2
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 2
Pain: moderate (n = 32, 116, 148)
|
53.1 percentage of participants
Interval 34.7 to 70.9
|
27.6 percentage of participants
Interval 19.7 to 36.7
|
33.1 percentage of participants
Interval 25.6 to 41.3
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 2
Pain: severe (n = 27, 104, 131)
|
14.8 percentage of participants
Interval 4.2 to 33.7
|
1.9 percentage of participants
Interval 0.2 to 6.8
|
4.6 percentage of participants
Interval 1.7 to 9.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Within 14 days after 13vPnC Dose 3Population: Safety population. Here 'N' (number of participants analyzed) signifies participants with known values for any local reaction and 'n' signifies participants with known values for specified local reaction. Participants may be represented in more than 1 category.
Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling were scaled as Any (redness present or swelling present); Mild (0.5 to 2.0 centimeters \[cm\] for participants aged 2 to \<12 years and 2.5 to 5.0 cm for participants aged \>= 12 years); Moderate (2.5 to 7.0 cm for participants aged 2 to \<12 years and 5.5 to 10.0 cm for participants aged \>= 12 years); Severe (greater than \[\>\] 7.0 cm for participants aged 2 to \<12 years and \>10.0 cm for participants aged \>= 12 years). Pain at injection site was scaled as Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity).
Outcome measures
| Measure |
13vPnC, 23vPS (All Participants)
n=37 Participants
All participants aged 2 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
|
13vPnC, 23vPS (Adult Participants)
n=138 Participants
Adult participants aged 18 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
|
13vPnC, 23vPS (All Participants)
n=175 Participants
All participants aged 2 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
|
|---|---|---|---|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 3
Pain: any (n = 37, 138, 175)
|
70.3 percentage of participants
Interval 53.0 to 84.1
|
73.2 percentage of participants
Interval 65.0 to 80.4
|
72.6 percentage of participants
Interval 65.3 to 79.0
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 3
Redness: any (n = 25, 95, 120)
|
32.0 percentage of participants
Interval 14.9 to 53.5
|
9.5 percentage of participants
Interval 4.4 to 17.2
|
14.2 percentage of participants
Interval 8.5 to 21.7
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 3
Redness: mild (n = 24, 94, 118)
|
20.8 percentage of participants
Interval 7.1 to 42.2
|
8.5 percentage of participants
Interval 3.7 to 16.1
|
11.0 percentage of participants
Interval 6.0 to 18.1
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 3
Redness: moderate (n = 24, 93, 117)
|
20.8 percentage of participants
Interval 7.1 to 42.2
|
1.1 percentage of participants
Interval 0.0 to 5.8
|
5.1 percentage of participants
Interval 1.9 to 10.8
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 3
Swelling: severe (n = 23, 92, 115)
|
4.3 percentage of participants
Interval 0.1 to 21.9
|
0.0 percentage of participants
Interval 0.0 to 3.9
|
0.9 percentage of participants
Interval 0.0 to 4.7
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 3
Pain: mild (n = 31, 132, 163)
|
64.5 percentage of participants
Interval 45.4 to 80.8
|
67.4 percentage of participants
Interval 58.7 to 75.3
|
66.9 percentage of participants
Interval 59.1 to 74.0
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 3
Redness: severe (n = 23, 93, 116)
|
4.3 percentage of participants
Interval 0.1 to 21.9
|
1.1 percentage of participants
Interval 0.0 to 5.8
|
1.7 percentage of participants
Interval 0.2 to 6.1
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 3
Swelling: any (n = 28, 93, 121)
|
35.7 percentage of participants
Interval 18.6 to 55.9
|
8.6 percentage of participants
Interval 3.8 to 16.2
|
14.9 percentage of participants
Interval 9.1 to 22.5
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 3
Swelling: mild (n = 27, 93, 120)
|
25.9 percentage of participants
Interval 11.1 to 46.3
|
8.6 percentage of participants
Interval 3.8 to 16.2
|
12.5 percentage of participants
Interval 7.2 to 19.8
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 3
Swelling: moderate (n = 25, 92, 117)
|
20.0 percentage of participants
Interval 6.8 to 40.7
|
0.0 percentage of participants
Interval 0.0 to 3.9
|
4.3 percentage of participants
Interval 1.4 to 9.7
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 3
Pain: moderate (n = 34, 107, 141)
|
38.2 percentage of participants
Interval 22.2 to 56.4
|
27.1 percentage of participants
Interval 19.0 to 36.6
|
29.8 percentage of participants
Interval 22.4 to 38.1
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 3
Pain: severe (n = 24, 93, 117)
|
8.3 percentage of participants
Interval 1.0 to 27.0
|
3.2 percentage of participants
Interval 0.7 to 9.1
|
4.3 percentage of participants
Interval 1.4 to 9.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Within 14 days after 13vPnC Dose 4Population: Safety population. Here 'N' (number of participants analyzed) signifies participants with known values for any local reaction and 'n' signifies participants with known values for specified local reaction. Participants may be represented in more than 1 category.
Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling were scaled as Any (redness present or swelling present); Mild (0.5 to 2.0 centimeters \[cm\] for participants aged 2 to \<12 years and 2.5 to 5.0 cm for participants aged \>= 12 years); Moderate (2.5 to 7.0 cm for participants aged 2 to \<12 years and 5.5 to 10.0 cm for participants aged \>= 12 years); Severe (greater than \[\>\] 7.0 cm for participants aged 2 to \<12 years and \>10.0 cm for participants aged \>= 12 years). Pain at injection site was scaled as Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity).
Outcome measures
| Measure |
13vPnC, 23vPS (All Participants)
n=35 Participants
All participants aged 2 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
|
13vPnC, 23vPS (Adult Participants)
n=116 Participants
Adult participants aged 18 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
|
13vPnC, 23vPS (All Participants)
n=151 Participants
All participants aged 2 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
|
|---|---|---|---|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 4
Redness: mild (n = 20, 77, 97)
|
50.0 percentage of participants
Interval 27.2 to 72.8
|
15.6 percentage of participants
Interval 8.3 to 25.6
|
22.7 percentage of participants
Interval 14.8 to 32.3
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 4
Redness: severe (n = 16, 73, 89)
|
12.5 percentage of participants
Interval 1.6 to 38.3
|
4.1 percentage of participants
Interval 0.9 to 11.5
|
5.6 percentage of participants
Interval 1.8 to 12.6
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 4
Swelling: any (n = 27, 81, 108)
|
66.7 percentage of participants
Interval 46.0 to 83.5
|
28.4 percentage of participants
Interval 18.9 to 39.5
|
38.0 percentage of participants
Interval 28.8 to 47.8
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 4
Pain: any (n = 30, 113, 143)
|
86.7 percentage of participants
Interval 69.3 to 96.2
|
77.0 percentage of participants
Interval 68.1 to 84.4
|
79.0 percentage of participants
Interval 71.4 to 85.4
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 4
Pain: mild (n = 25, 105, 130)
|
76.0 percentage of participants
Interval 54.9 to 90.6
|
71.4 percentage of participants
Interval 61.8 to 79.8
|
72.3 percentage of participants
Interval 63.8 to 79.8
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 4
Pain: moderate (n = 24, 85, 109)
|
62.5 percentage of participants
Interval 40.6 to 81.2
|
31.8 percentage of participants
Interval 22.1 to 42.8
|
38.5 percentage of participants
Interval 29.4 to 48.3
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 4
Pain: severe (n = 16, 74, 90)
|
12.5 percentage of participants
Interval 1.6 to 38.3
|
5.4 percentage of participants
Interval 1.5 to 13.3
|
6.7 percentage of participants
Interval 2.5 to 13.9
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 4
Redness: any (n = 21, 79, 100)
|
71.4 percentage of participants
Interval 47.8 to 88.7
|
22.8 percentage of participants
Interval 14.1 to 33.6
|
33.0 percentage of participants
Interval 23.9 to 43.1
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 4
Redness: moderate (n = 18, 72, 90)
|
50.0 percentage of participants
Interval 26.0 to 74.0
|
9.7 percentage of participants
Interval 4.0 to 19.0
|
17.8 percentage of participants
Interval 10.5 to 27.3
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 4
Swelling: mild (n = 21, 79, 100)
|
38.1 percentage of participants
Interval 18.1 to 61.6
|
21.5 percentage of participants
Interval 13.1 to 32.2
|
25.0 percentage of participants
Interval 16.9 to 34.7
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 4
Swelling: moderate (n = 23, 72, 95)
|
52.2 percentage of participants
Interval 30.6 to 73.2
|
6.9 percentage of participants
Interval 2.3 to 15.5
|
17.9 percentage of participants
Interval 10.8 to 27.1
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 4
Swelling: severe (n = 15, 73, 88)
|
6.7 percentage of participants
Interval 0.2 to 31.9
|
4.1 percentage of participants
Interval 0.9 to 11.5
|
4.5 percentage of participants
Interval 1.3 to 11.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Within 14 days after 13vPnC Dose 1Population: Safety population. Here 'N' (number of participants analyzed) signifies participants with known values for any systemic event and 'n' signifies participants with known values for specified systemic event. Participants may be represented in more than 1 category.
Specific systemic events (fever \>=38 degrees Celsius \[C\], fatigue, headache, vomiting, diarrhea, muscle pain, joint pain and use of medication to treat pain/fever) were prompted for each day, and reported using an electronic diary. Fatigue, headache, muscle pain and joint pain were scaled as: Any (symptom present); Mild (did not interfere with activity); Moderate (some interference with activity); Severe (prevented routine daily activity). Vomiting was scaled as: Any (vomiting present); Mild (1-2 times in 24 hours); Moderate (\>2 times in 24 hours); Severe (required intravenous hydration). Diarrhea was scaled as: Any (diarrhea present); Mild (2-3 loose stools in 24 hours); Moderate (4-5 loose stools 24 hours); Severe (\>=6 loose stools in 24 hours).
Outcome measures
| Measure |
13vPnC, 23vPS (All Participants)
n=51 Participants
All participants aged 2 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
|
13vPnC, 23vPS (Adult Participants)
n=172 Participants
Adult participants aged 18 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
|
13vPnC, 23vPS (All Participants)
n=223 Participants
All participants aged 2 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
|
|---|---|---|---|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 1
Fever: >=38, <38.5 degrees C (n = 37, 130, 167)
|
5.4 percentage of participants
Interval 0.7 to 18.2
|
6.2 percentage of participants
Interval 2.7 to 11.8
|
6.0 percentage of participants
Interval 2.9 to 10.7
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 1
Fever: >=38.5, <39 degrees C (n = 37, 128, 165)
|
5.4 percentage of participants
Interval 0.7 to 18.2
|
0.0 percentage of participants
Interval 0.0 to 2.8
|
1.2 percentage of participants
Interval 0.1 to 4.3
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 1
Fever: >=39, =<40 degrees C (n = 39, 128, 167)
|
7.7 percentage of participants
Interval 1.6 to 20.9
|
0.0 percentage of participants
Interval 0.0 to 2.8
|
1.8 percentage of participants
Interval 0.4 to 5.2
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 1
Fever: >40 degrees C (n = 37, 128, 165)
|
0.0 percentage of participants
Interval 0.0 to 9.5
|
0.0 percentage of participants
Interval 0.0 to 2.8
|
0.0 percentage of participants
Interval 0.0 to 2.2
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 1
Fatigue: Severe (n = 37, 136, 173)
|
10.8 percentage of participants
Interval 3.0 to 25.4
|
11.8 percentage of participants
Interval 6.9 to 18.4
|
11.6 percentage of participants
Interval 7.2 to 17.3
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 1
Headache: Severe (n = 37, 130, 167)
|
2.7 percentage of participants
Interval 0.1 to 14.2
|
2.3 percentage of participants
Interval 0.5 to 6.6
|
2.4 percentage of participants
Interval 0.7 to 6.0
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 1
Vomiting: Moderate (n = 38, 128, 166)
|
2.6 percentage of participants
Interval 0.1 to 13.8
|
3.9 percentage of participants
Interval 1.3 to 8.9
|
3.6 percentage of participants
Interval 1.3 to 7.7
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 1
Muscle Pain: Moderate (n = 44, 139, 183)
|
36.4 percentage of participants
Interval 22.4 to 52.2
|
21.6 percentage of participants
Interval 15.1 to 29.4
|
25.1 percentage of participants
Interval 19.0 to 32.1
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 1
Joint Pain: Mild (n = 37, 139, 176)
|
18.9 percentage of participants
Interval 8.0 to 35.2
|
19.4 percentage of participants
Interval 13.2 to 27.0
|
19.3 percentage of participants
Interval 13.8 to 25.9
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 1
Joint Pain: Moderate (n = 38, 137, 175)
|
15.8 percentage of participants
Interval 6.0 to 31.3
|
14.6 percentage of participants
Interval 9.2 to 21.6
|
14.9 percentage of participants
Interval 9.9 to 21.0
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 1
Use of Medication to Treat Fever (n= 41, 133, 174)
|
24.4 percentage of participants
Interval 12.4 to 40.3
|
14.3 percentage of participants
Interval 8.8 to 21.4
|
16.7 percentage of participants
Interval 11.5 to 23.1
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 1
Vomiting: Severe (n = 37, 128, 165)
|
5.4 percentage of participants
Interval 0.7 to 18.2
|
0.0 percentage of participants
Interval 0.0 to 2.8
|
1.2 percentage of participants
Interval 0.1 to 4.3
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 1
Diarrhea: Any (n = 44, 145, 189)
|
31.8 percentage of participants
Interval 18.6 to 47.6
|
35.9 percentage of participants
Interval 28.1 to 44.2
|
34.9 percentage of participants
Interval 28.1 to 42.2
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 1
Diarrhea: Mild (n = 44, 142, 186)
|
31.8 percentage of participants
Interval 18.6 to 47.6
|
33.8 percentage of participants
Interval 26.1 to 42.2
|
33.3 percentage of participants
Interval 26.6 to 40.6
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 1
Diarrhea: Moderate (n = 38, 133, 171)
|
5.3 percentage of participants
Interval 0.6 to 17.7
|
9.0 percentage of participants
Interval 4.7 to 15.2
|
8.2 percentage of participants
Interval 4.5 to 13.4
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 1
Diarrhea: Severe (n = 37, 131, 168)
|
0.0 percentage of participants
Interval 0.0 to 9.5
|
3.8 percentage of participants
Interval 1.3 to 8.7
|
3.0 percentage of participants
Interval 1.0 to 6.8
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 1
Muscle Pain: Any (n = 47, 154, 201)
|
55.3 percentage of participants
Interval 40.1 to 69.8
|
50.0 percentage of participants
Interval 41.8 to 58.2
|
51.2 percentage of participants
Interval 44.1 to 58.3
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 1
Muscle Pain: Mild (n = 43, 148, 191)
|
46.5 percentage of participants
Interval 31.2 to 62.3
|
42.6 percentage of participants
Interval 34.5 to 51.0
|
43.5 percentage of participants
Interval 36.3 to 50.8
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 1
Muscle Pain: Severe (n = 37, 131, 168)
|
5.4 percentage of participants
Interval 0.7 to 18.2
|
5.3 percentage of participants
Interval 2.2 to 10.7
|
5.4 percentage of participants
Interval 2.5 to 9.9
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 1
Joint Pain: Any (n = 38, 143, 181)
|
26.3 percentage of participants
Interval 13.4 to 43.1
|
26.6 percentage of participants
Interval 19.5 to 34.6
|
26.5 percentage of participants
Interval 20.2 to 33.6
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 1
Joint Pain: Severe (n = 37, 130, 167)
|
2.7 percentage of participants
Interval 0.1 to 14.2
|
3.1 percentage of participants
Interval 0.8 to 7.7
|
3.0 percentage of participants
Interval 1.0 to 6.8
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 1
Use of Medication to Treat Pain (n= 40, 136, 176)
|
25.0 percentage of participants
Interval 12.7 to 41.2
|
13.2 percentage of participants
Interval 8.0 to 20.1
|
15.9 percentage of participants
Interval 10.8 to 22.2
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 1
Fever: >=38 degrees C (n = 39, 130, 169)
|
12.8 percentage of participants
Interval 4.3 to 27.4
|
6.2 percentage of participants
Interval 2.7 to 11.8
|
7.7 percentage of participants
Interval 4.2 to 12.8
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 1
Fatigue: Any (n = 45, 159, 204)
|
53.3 percentage of participants
Interval 37.9 to 68.3
|
59.7 percentage of participants
Interval 51.7 to 67.4
|
58.3 percentage of participants
Interval 51.2 to 65.2
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 1
Fatigue: Mild (n = 41, 149, 190)
|
36.6 percentage of participants
Interval 22.1 to 53.1
|
49.0 percentage of participants
Interval 40.7 to 57.3
|
46.3 percentage of participants
Interval 39.1 to 53.7
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 1
Fatigue: Moderate (n = 44, 148, 192)
|
36.4 percentage of participants
Interval 22.4 to 52.2
|
35.8 percentage of participants
Interval 28.1 to 44.1
|
35.9 percentage of participants
Interval 29.2 to 43.2
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 1
Headache: Any (n = 42, 147, 189)
|
45.2 percentage of participants
Interval 29.8 to 61.3
|
44.2 percentage of participants
Interval 36.0 to 52.6
|
44.4 percentage of participants
Interval 37.2 to 51.8
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 1
Headache: Mild (n = 41, 145, 186)
|
39.0 percentage of participants
Interval 24.2 to 55.5
|
37.9 percentage of participants
Interval 30.0 to 46.4
|
38.2 percentage of participants
Interval 31.2 to 45.6
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 1
Headache: Moderate (n = 40, 134, 174)
|
20.0 percentage of participants
Interval 9.1 to 35.6
|
17.2 percentage of participants
Interval 11.2 to 24.6
|
17.8 percentage of participants
Interval 12.4 to 24.3
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 1
Vomiting: Any (n = 39, 134, 173)
|
20.5 percentage of participants
Interval 9.3 to 36.5
|
20.9 percentage of participants
Interval 14.4 to 28.8
|
20.8 percentage of participants
Interval 15.0 to 27.6
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 1
Vomiting: Mild (n = 38, 134, 172)
|
18.4 percentage of participants
Interval 7.7 to 34.3
|
17.9 percentage of participants
Interval 11.8 to 25.5
|
18.0 percentage of participants
Interval 12.6 to 24.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Within 14 days after 13vPnC Dose 2Population: Safety population. Here 'N' (number of participants analyzed) signifies participants with known values for any systemic event and 'n' signifies participants with known values for specified systemic event. Participants may be represented in more than 1 category.
Specific systemic events (fever \>=38 degrees Celsius \[C\], fatigue, headache, vomiting, diarrhea, muscle pain, joint pain and use of medication to treat pain/fever) were prompted for each day, and reported using an electronic diary. Fatigue, headache, muscle pain and joint pain were scaled as: Any (symptom present); Mild (did not interfere with activity); Moderate (some interference with activity); Severe (prevented routine daily activity). Vomiting was scaled as: Any (vomiting present); Mild (1-2 times in 24 hours); Moderate (\>2 times in 24 hours); Severe (required intravenous hydration). Diarrhea was scaled as: Any (diarrhea present); Mild (2-3 loose stools in 24 hours); Moderate (4-5 loose stools 24 hours); Severe (\>=6 loose stools in 24 hours).
Outcome measures
| Measure |
13vPnC, 23vPS (All Participants)
n=45 Participants
All participants aged 2 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
|
13vPnC, 23vPS (Adult Participants)
n=146 Participants
Adult participants aged 18 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
|
13vPnC, 23vPS (All Participants)
n=191 Participants
All participants aged 2 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
|
|---|---|---|---|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 2
Fever: >=38 degrees C (n = 26, 105, 131)
|
23.1 percentage of participants
Interval 9.0 to 43.6
|
6.7 percentage of participants
Interval 2.7 to 13.3
|
9.9 percentage of participants
Interval 5.4 to 16.4
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 2
Fever: >=38, <38.5 degrees C (n = 26, 105, 131)
|
19.2 percentage of participants
Interval 6.6 to 39.4
|
5.7 percentage of participants
Interval 2.1 to 12.0
|
8.4 percentage of participants
Interval 4.3 to 14.5
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 2
Fever: >=38.5, <39 degrees C (n = 24, 102, 126)
|
8.3 percentage of participants
Interval 1.0 to 27.0
|
1.0 percentage of participants
Interval 0.0 to 5.3
|
2.4 percentage of participants
Interval 0.5 to 6.8
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 2
Fever: >=39, =<40 degrees C (n = 24, 102, 126)
|
8.3 percentage of participants
Interval 1.0 to 27.0
|
1.0 percentage of participants
Interval 0.0 to 5.3
|
2.4 percentage of participants
Interval 0.5 to 6.8
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 2
Fever: >40 degrees C (n = 24, 102, 126)
|
0.0 percentage of participants
Interval 0.0 to 14.2
|
0.0 percentage of participants
Interval 0.0 to 3.6
|
0.0 percentage of participants
Interval 0.0 to 2.9
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 2
Fatigue: Any (n = 38, 133, 171)
|
60.5 percentage of participants
Interval 43.4 to 76.0
|
56.4 percentage of participants
Interval 47.5 to 65.0
|
57.3 percentage of participants
Interval 49.5 to 64.8
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 2
Fatigue: Mild (n = 31, 125, 156)
|
45.2 percentage of participants
Interval 27.3 to 64.0
|
39.2 percentage of participants
Interval 30.6 to 48.3
|
40.4 percentage of participants
Interval 32.6 to 48.5
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 2
Fatigue: Moderate (n = 33, 122, 155)
|
45.5 percentage of participants
Interval 28.1 to 63.6
|
37.7 percentage of participants
Interval 29.1 to 46.9
|
39.4 percentage of participants
Interval 31.6 to 47.5
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 2
Fatigue: Severe (n = 24, 107, 131)
|
12.5 percentage of participants
Interval 2.7 to 32.4
|
9.3 percentage of participants
Interval 4.6 to 16.5
|
9.9 percentage of participants
Interval 5.4 to 16.4
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 2
Headache: Mild (n = 30, 117, 147)
|
30.0 percentage of participants
Interval 14.7 to 49.4
|
29.9 percentage of participants
Interval 21.8 to 39.1
|
29.9 percentage of participants
Interval 22.7 to 38.0
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 2
Headache: Any (n = 31, 121,152)
|
32.3 percentage of participants
Interval 16.7 to 51.4
|
35.5 percentage of participants
Interval 27.0 to 44.8
|
34.9 percentage of participants
Interval 27.3 to 43.0
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 2
Headache: Moderate (n = 26, 110, 136)
|
7.7 percentage of participants
Interval 0.9 to 25.1
|
16.4 percentage of participants
Interval 10.0 to 24.6
|
14.7 percentage of participants
Interval 9.2 to 21.8
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 2
Headache: Severe (n = 24, 104, 128)
|
0.0 percentage of participants
Interval 0.0 to 14.2
|
1.9 percentage of participants
Interval 0.2 to 6.8
|
1.6 percentage of participants
Interval 0.2 to 5.5
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 2
Vomiting: Any (n = 28, 107, 135)
|
21.4 percentage of participants
Interval 8.3 to 41.0
|
13.1 percentage of participants
Interval 7.3 to 21.0
|
14.8 percentage of participants
Interval 9.3 to 21.9
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 2
Vomiting: Mild (n = 27, 107, 134)
|
18.5 percentage of participants
Interval 6.3 to 38.1
|
10.3 percentage of participants
Interval 5.2 to 17.7
|
11.9 percentage of participants
Interval 7.0 to 18.7
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 2
Vomiting: Moderate (n = 28, 103, 131)
|
14.3 percentage of participants
Interval 4.0 to 32.7
|
4.9 percentage of participants
Interval 1.6 to 11.0
|
6.9 percentage of participants
Interval 3.2 to 12.6
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 2
Vomiting: Severe (n = 24, 102, 126)
|
0.0 percentage of participants
Interval 0.0 to 14.2
|
1.0 percentage of participants
Interval 0.0 to 5.3
|
0.8 percentage of participants
Interval 0.0 to 4.3
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 2
Diarrhea: Any (n = 29, 121, 150)
|
31.0 percentage of participants
Interval 15.3 to 50.8
|
28.9 percentage of participants
Interval 21.0 to 37.9
|
29.3 percentage of participants
Interval 22.2 to 37.3
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 2
Diarrhea: Mild (n = 29, 120, 149)
|
31.0 percentage of participants
Interval 15.3 to 50.8
|
26.7 percentage of participants
Interval 19.0 to 35.5
|
27.5 percentage of participants
Interval 20.5 to 35.4
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 2
Diarrhea: Moderate (n = 25, 109, 134)
|
8.0 percentage of participants
Interval 1.0 to 26.0
|
10.1 percentage of participants
Interval 5.1 to 17.3
|
9.7 percentage of participants
Interval 5.3 to 16.0
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 2
Diarrhea: Severe (n = 24, 103, 127)
|
0.0 percentage of participants
Interval 0.0 to 14.2
|
1.9 percentage of participants
Interval 0.2 to 6.8
|
1.6 percentage of participants
Interval 0.2 to 5.6
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 2
Muscle Pain: Any (n = 36, 124, 160)
|
44.4 percentage of participants
Interval 27.9 to 61.9
|
45.2 percentage of participants
Interval 36.2 to 54.3
|
45.0 percentage of participants
Interval 37.1 to 53.1
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 2
Muscle Pain: Mild (n = 32, 118, 150)
|
31.3 percentage of participants
Interval 16.1 to 50.0
|
37.3 percentage of participants
Interval 28.6 to 46.7
|
36.0 percentage of participants
Interval 28.3 to 44.2
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 2
Muscle Pain: Moderate (n = 32, 111, 143)
|
37.5 percentage of participants
Interval 21.1 to 56.3
|
25.2 percentage of participants
Interval 17.5 to 34.4
|
28.0 percentage of participants
Interval 20.8 to 36.1
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 2
Muscle Pain: Severe (n = 25, 106, 131)
|
8.0 percentage of participants
Interval 1.0 to 26.0
|
5.7 percentage of participants
Interval 2.1 to 11.9
|
6.1 percentage of participants
Interval 2.7 to 11.7
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 2
Joint Pain: Any (n = 31, 116, 147)
|
32.3 percentage of participants
Interval 16.7 to 51.4
|
23.3 percentage of participants
Interval 15.9 to 32.0
|
25.2 percentage of participants
Interval 18.4 to 33.0
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 2
Joint Pain: Mild (n = 27, 115, 142)
|
18.5 percentage of participants
Interval 6.3 to 38.1
|
21.7 percentage of participants
Interval 14.6 to 30.4
|
21.1 percentage of participants
Interval 14.7 to 28.8
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 2
Joint Pain: Moderate (n = 30, 106, 136)
|
30.0 percentage of participants
Interval 14.7 to 49.4
|
10.4 percentage of participants
Interval 5.3 to 17.8
|
14.7 percentage of participants
Interval 9.2 to 21.8
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 2
Joint Pain: Severe (n = 25, 104, 129)
|
4.0 percentage of participants
Interval 0.1 to 20.4
|
1.9 percentage of participants
Interval 0.2 to 6.8
|
2.3 percentage of participants
Interval 0.5 to 6.6
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 2
Use of Medication to Treat Pain (n= 28, 105, 133)
|
25.0 percentage of participants
Interval 10.7 to 44.9
|
7.6 percentage of participants
Interval 3.3 to 14.5
|
11.3 percentage of participants
Interval 6.5 to 17.9
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 2
Use of Medication to Treat Fever (n= 27, 107, 134)
|
33.3 percentage of participants
Interval 16.5 to 54.0
|
10.3 percentage of participants
Interval 5.2 to 17.7
|
14.9 percentage of participants
Interval 9.4 to 22.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Within 14 days after 13vPnC Dose 3Population: Safety population. Here 'N' (number of participants analyzed) signifies participants with known values for any systemic event and 'n' signifies participants with known values for specified systemic event. Participants may be represented in more than 1 category.
Specific systemic events (fever \>=38 degrees Celsius \[C\], fatigue, headache, vomiting, diarrhea, muscle pain, joint pain and use of medication to treat pain/fever) were prompted for each day, and reported using an electronic diary. Fatigue, headache, muscle pain and joint pain were scaled as: Any (symptom present); Mild (did not interfere with activity); Moderate (some interference with activity); Severe (prevented routine daily activity). Vomiting was scaled as: Any (vomiting present); Mild (1-2 times in 24 hours); Moderate (\>2 times in 24 hours); Severe (required intravenous hydration). Diarrhea was scaled as: Any (diarrhea present); Mild (2-3 loose stools in 24 hours); Moderate (4-5 loose stools 24 hours); Severe (\>=6 loose stools in 24 hours).
Outcome measures
| Measure |
13vPnC, 23vPS (All Participants)
n=42 Participants
All participants aged 2 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
|
13vPnC, 23vPS (Adult Participants)
n=136 Participants
Adult participants aged 18 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
|
13vPnC, 23vPS (All Participants)
n=178 Participants
All participants aged 2 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
|
|---|---|---|---|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 3
Diarrhea: Mild (n = 26, 102, 128)
|
15.4 percentage of participants
Interval 4.4 to 34.9
|
21.6 percentage of participants
Interval 14.0 to 30.8
|
20.3 percentage of participants
Interval 13.7 to 28.3
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 3
Fever: >=38 degrees C (n = 27, 93, 120)
|
14.8 percentage of participants
Interval 4.2 to 33.7
|
4.3 percentage of participants
Interval 1.2 to 10.6
|
6.7 percentage of participants
Interval 2.9 to 12.7
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 3
Fever: >=38, <38.5 degrees C (n = 26, 93, 119)
|
11.5 percentage of participants
Interval 2.4 to 30.2
|
3.2 percentage of participants
Interval 0.7 to 9.1
|
5.0 percentage of participants
Interval 1.9 to 10.7
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 3
Fever: >=38.5, <39 degrees C (n = 24, 93, 117)
|
4.2 percentage of participants
Interval 0.1 to 21.1
|
3.2 percentage of participants
Interval 0.7 to 9.1
|
3.4 percentage of participants
Interval 0.9 to 8.5
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 3
Fever: >=39, =<40 degrees C (n = 24, 92, 116)
|
4.2 percentage of participants
Interval 0.1 to 21.1
|
1.1 percentage of participants
Interval 0.0 to 5.9
|
1.7 percentage of participants
Interval 0.2 to 6.1
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 3
Fever: >40 degrees C (n = 23, 92, 115)
|
0.0 percentage of participants
Interval 0.0 to 14.8
|
0.0 percentage of participants
Interval 0.0 to 3.9
|
0.0 percentage of participants
Interval 0.0 to 3.2
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 3
Fatigue: Any (n = 35, 122, 157)
|
48.6 percentage of participants
Interval 31.4 to 66.0
|
49.2 percentage of participants
Interval 40.0 to 58.4
|
49.0 percentage of participants
Interval 41.0 to 57.1
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 3
Fatigue: Mild (n = 32, 116, 148)
|
40.6 percentage of participants
Interval 23.7 to 59.4
|
38.8 percentage of participants
Interval 29.9 to 48.3
|
39.2 percentage of participants
Interval 31.3 to 47.5
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 3
Fatigue: Moderate (n = 30, 107, 137)
|
33.3 percentage of participants
Interval 17.3 to 52.8
|
29.9 percentage of participants
Interval 21.4 to 39.5
|
30.7 percentage of participants
Interval 23.1 to 39.1
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 3
Fatigue: Severe (n = 24, 96, 120)
|
4.2 percentage of participants
Interval 0.1 to 21.1
|
7.3 percentage of participants
Interval 3.0 to 14.4
|
6.7 percentage of participants
Interval 2.9 to 12.7
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 3
Headache: Any (n = 32, 110,142)
|
37.5 percentage of participants
Interval 21.1 to 56.3
|
37.3 percentage of participants
Interval 28.2 to 47.0
|
37.3 percentage of participants
Interval 29.4 to 45.8
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 3
Headache: Mild (n = 30, 108, 138)
|
30.0 percentage of participants
Interval 14.7 to 49.4
|
32.4 percentage of participants
Interval 23.7 to 42.1
|
31.9 percentage of participants
Interval 24.2 to 40.4
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 3
Headache: Moderate (n = 27, 95, 122)
|
22.2 percentage of participants
Interval 8.6 to 42.3
|
15.8 percentage of participants
Interval 9.1 to 24.7
|
17.2 percentage of participants
Interval 11.0 to 25.1
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 3
Headache: Severe (n = 25, 94, 119)
|
8.0 percentage of participants
Interval 1.0 to 26.0
|
2.1 percentage of participants
Interval 0.3 to 7.5
|
3.4 percentage of participants
Interval 0.9 to 8.4
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 3
Vomiting: Any (n = 25, 95, 120)
|
8.0 percentage of participants
Interval 1.0 to 26.0
|
11.6 percentage of participants
Interval 5.9 to 19.8
|
10.8 percentage of participants
Interval 5.9 to 17.8
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 3
Vomiting: Mild (n = 24, 95, 119)
|
4.2 percentage of participants
Interval 0.1 to 21.1
|
5.3 percentage of participants
Interval 1.7 to 11.9
|
5.0 percentage of participants
Interval 1.9 to 10.7
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 3
Vomiting: Moderate (n = 24, 93, 117)
|
4.2 percentage of participants
Interval 0.1 to 21.1
|
7.5 percentage of participants
Interval 3.1 to 14.9
|
6.8 percentage of participants
Interval 3.0 to 13.0
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 3
Vomiting: Severe (n = 23, 92, 115)
|
0.0 percentage of participants
Interval 0.0 to 14.8
|
0.0 percentage of participants
Interval 0.0 to 3.9
|
0.0 percentage of participants
Interval 0.0 to 3.2
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 3
Diarrhea: Any (n = 26, 104, 130)
|
15.4 percentage of participants
Interval 4.4 to 34.9
|
25.0 percentage of participants
Interval 17.0 to 34.4
|
23.1 percentage of participants
Interval 16.1 to 31.3
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 3
Diarrhea: Moderate (n = 24, 95, 119)
|
4.2 percentage of participants
Interval 0.1 to 21.1
|
5.3 percentage of participants
Interval 1.7 to 11.9
|
5.0 percentage of participants
Interval 1.9 to 10.7
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 3
Diarrhea: Severe (n = 23, 94, 117)
|
0.0 percentage of participants
Interval 0.0 to 14.8
|
2.1 percentage of participants
Interval 0.3 to 7.5
|
1.7 percentage of participants
Interval 0.2 to 6.0
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 3
Muscle Pain: Any (n = 35, 117, 152)
|
45.7 percentage of participants
Interval 28.8 to 63.4
|
38.5 percentage of participants
Interval 29.6 to 47.9
|
40.1 percentage of participants
Interval 32.3 to 48.4
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 3
Muscle Pain: Mild (n = 30, 112, 142)
|
33.3 percentage of participants
Interval 17.3 to 52.8
|
33.0 percentage of participants
Interval 24.4 to 42.6
|
33.1 percentage of participants
Interval 25.4 to 41.5
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 3
Muscle Pain: Moderate (n = 31, 101, 132)
|
32.3 percentage of participants
Interval 16.7 to 51.4
|
16.8 percentage of participants
Interval 10.1 to 25.6
|
20.5 percentage of participants
Interval 13.9 to 28.3
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 3
Muscle Pain: Severe (n = 24, 94, 118)
|
4.2 percentage of participants
Interval 0.1 to 21.1
|
3.2 percentage of participants
Interval 0.7 to 9.0
|
3.4 percentage of participants
Interval 0.9 to 8.5
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 3
Joint Pain: Any (n = 28, 104, 132)
|
25.0 percentage of participants
Interval 10.7 to 44.9
|
20.2 percentage of participants
Interval 13.0 to 29.2
|
21.2 percentage of participants
Interval 14.6 to 29.2
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 3
Joint Pain: Mild (n = 26, 102, 128)
|
19.2 percentage of participants
Interval 6.6 to 39.4
|
17.6 percentage of participants
Interval 10.8 to 26.4
|
18.0 percentage of participants
Interval 11.7 to 25.7
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 3
Joint Pain: Moderate (n = 27, 95, 122)
|
18.5 percentage of participants
Interval 6.3 to 38.1
|
8.4 percentage of participants
Interval 3.7 to 15.9
|
10.7 percentage of participants
Interval 5.8 to 17.5
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 3
Joint Pain: Severe (n = 25, 94, 119)
|
8.0 percentage of participants
Interval 1.0 to 26.0
|
2.1 percentage of participants
Interval 0.3 to 7.5
|
3.4 percentage of participants
Interval 0.9 to 8.4
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 3
Use of Medication to Treat Pain (n= 28, 97, 125)
|
21.4 percentage of participants
Interval 8.3 to 41.0
|
12.4 percentage of participants
Interval 6.6 to 20.6
|
14.4 percentage of participants
Interval 8.8 to 21.8
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 3
Use of Medication to Treat Fever (n= 30, 101, 131)
|
26.7 percentage of participants
Interval 12.3 to 45.9
|
15.8 percentage of participants
Interval 9.3 to 24.4
|
18.3 percentage of participants
Interval 12.1 to 26.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Within 14 days after 13vPnC Dose 4Population: Safety population. Here 'N' (number of participants analyzed) signifies participants with known values for any systemic event and 'n' signifies participants with known values for specified systemic event. Participants may be represented in more than 1 category.
Specific systemic events (fever \>=38 degrees Celsius \[C\], fatigue, headache, vomiting, diarrhea, muscle pain, joint pain and use of medication to treat pain/fever) were prompted for each day, and reported using an electronic diary. Fatigue, headache, muscle pain and joint pain were scaled as: Any (symptom present); Mild (did not interfere with activity); Moderate (some interference with activity); Severe (prevented routine daily activity). Vomiting was scaled as: Any (vomiting present); Mild (1-2 times in 24 hours); Moderate (\>2 times in 24 hours); Severe (required intravenous hydration). Diarrhea was scaled as: Any (diarrhea present); Mild (2-3 loose stools in 24 hours); Moderate (4-5 loose stools 24 hours); Severe (\>=6 loose stools in 24 hours).
Outcome measures
| Measure |
13vPnC, 23vPS (All Participants)
n=32 Participants
All participants aged 2 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
|
13vPnC, 23vPS (Adult Participants)
n=116 Participants
Adult participants aged 18 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
|
13vPnC, 23vPS (All Participants)
n=148 Participants
All participants aged 2 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
|
|---|---|---|---|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4
Fever: >=38 degrees C (n= 18, 78, 96)
|
27.8 percentage of participants
Interval 9.7 to 53.5
|
15.4 percentage of participants
Interval 8.2 to 25.3
|
17.7 percentage of participants
Interval 10.7 to 26.8
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4
Fever: >=38, <38.5 degrees C (n = 16, 76, 92)
|
12.5 percentage of participants
Interval 1.6 to 38.3
|
13.2 percentage of participants
Interval 6.5 to 22.9
|
13.0 percentage of participants
Interval 6.9 to 21.7
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4
Fever: >=38.5, <39 degrees C (n = 17, 73, 90)
|
17.6 percentage of participants
Interval 3.8 to 43.4
|
2.7 percentage of participants
Interval 0.3 to 9.5
|
5.6 percentage of participants
Interval 1.8 to 12.5
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4
Fever: >=39, =<40 degrees C (n = 15, 72, 87)
|
0.0 percentage of participants
Interval 0.0 to 21.8
|
2.8 percentage of participants
Interval 0.3 to 9.7
|
2.3 percentage of participants
Interval 0.3 to 8.1
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4
Fever: >40 degrees C (n = 15, 71, 86)
|
0.0 percentage of participants
Interval 0.0 to 21.8
|
0.0 percentage of participants
Interval 0.0 to 5.1
|
0.0 percentage of participants
Interval 0.0 to 4.2
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4
Fatigue: Any (n = 28, 100, 128)
|
67.9 percentage of participants
Interval 47.6 to 84.1
|
67.0 percentage of participants
Interval 56.9 to 76.1
|
67.2 percentage of participants
Interval 58.3 to 75.2
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4
Fatigue: Mild (n = 26, 95, 121)
|
61.5 percentage of participants
Interval 40.6 to 79.8
|
54.7 percentage of participants
Interval 44.2 to 65.0
|
56.2 percentage of participants
Interval 46.9 to 65.2
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4
Fatigue: Moderate (n = 20, 86, 106)
|
45.0 percentage of participants
Interval 23.1 to 68.5
|
45.3 percentage of participants
Interval 34.6 to 56.5
|
45.3 percentage of participants
Interval 35.6 to 55.2
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4
Fatigue: Severe (n = 16, 77, 93)
|
12.5 percentage of participants
Interval 1.6 to 38.3
|
13.0 percentage of participants
Interval 6.4 to 22.6
|
12.9 percentage of participants
Interval 6.8 to 21.5
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4
Headache: Any (n = 21, 93, 114)
|
52.4 percentage of participants
Interval 29.8 to 74.3
|
45.2 percentage of participants
Interval 34.8 to 55.8
|
46.5 percentage of participants
Interval 37.1 to 56.1
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4
Headache: Mild (n = 21, 88, 109)
|
47.6 percentage of participants
Interval 25.7 to 70.2
|
38.6 percentage of participants
Interval 28.4 to 49.6
|
40.4 percentage of participants
Interval 31.1 to 50.2
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4
Headache: Moderate (n = 16, 82, 98)
|
18.8 percentage of participants
Interval 4.0 to 45.6
|
28.0 percentage of participants
Interval 18.7 to 39.1
|
26.5 percentage of participants
Interval 18.1 to 36.4
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4
Headache: Severe (n = 16, 74, 90)
|
12.5 percentage of participants
Interval 1.6 to 38.3
|
5.4 percentage of participants
Interval 1.5 to 13.3
|
6.7 percentage of participants
Interval 2.5 to 13.9
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4
Vomiting: Any (n = 16, 73, 89)
|
6.3 percentage of participants
Interval 0.2 to 30.2
|
5.5 percentage of participants
Interval 1.5 to 13.4
|
5.6 percentage of participants
Interval 1.8 to 12.6
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4
Vomiting: Mild (n = 16, 73, 89)
|
6.3 percentage of participants
Interval 0.2 to 30.2
|
5.5 percentage of participants
Interval 1.5 to 13.4
|
5.6 percentage of participants
Interval 1.8 to 12.6
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4
Vomiting: Moderate (n = 15, 71, 86)
|
0.0 percentage of participants
Interval 0.0 to 21.8
|
0.0 percentage of participants
Interval 0.0 to 5.1
|
0.0 percentage of participants
Interval 0.0 to 4.2
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4
Vomiting: Severe (n = 15, 71, 86)
|
0.0 percentage of participants
Interval 0.0 to 21.8
|
0.0 percentage of participants
Interval 0.0 to 5.1
|
0.0 percentage of participants
Interval 0.0 to 4.2
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4
Diarrhea: Any (n = 18, 83, 101)
|
22.2 percentage of participants
Interval 6.4 to 47.6
|
30.1 percentage of participants
Interval 20.5 to 41.2
|
28.7 percentage of participants
Interval 20.1 to 38.6
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4
Diarrhea: Mild (n = 18, 82, 100)
|
22.2 percentage of participants
Interval 6.4 to 47.6
|
29.3 percentage of participants
Interval 19.7 to 40.4
|
28.0 percentage of participants
Interval 19.5 to 37.9
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4
Diarrhea: Moderate (n = 15, 72, 87)
|
0.0 percentage of participants
Interval 0.0 to 21.8
|
4.2 percentage of participants
Interval 0.9 to 11.7
|
3.4 percentage of participants
Interval 0.7 to 9.7
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4
Diarrhea: Severe (n = 15, 72, 87)
|
0.0 percentage of participants
Interval 0.0 to 21.8
|
1.4 percentage of participants
Interval 0.0 to 7.5
|
1.1 percentage of participants
Interval 0.0 to 6.2
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4
Muscle Pain: Any (n = 24, 99, 123)
|
58.3 percentage of participants
Interval 36.6 to 77.9
|
60.6 percentage of participants
Interval 50.3 to 70.3
|
60.2 percentage of participants
Interval 50.9 to 68.9
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4
Muscle Pain: Mild (n = 22, 92, 114)
|
50.0 percentage of participants
Interval 28.2 to 71.8
|
50.0 percentage of participants
Interval 39.4 to 60.6
|
50.0 percentage of participants
Interval 40.5 to 59.5
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4
Muscle Pain: Moderate (n = 19, 80, 99)
|
36.8 percentage of participants
Interval 16.3 to 61.6
|
30.0 percentage of participants
Interval 20.3 to 41.3
|
31.3 percentage of participants
Interval 22.4 to 41.4
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4
Muscle Pain: Severe (n = 16, 75, 91)
|
12.5 percentage of participants
Interval 1.6 to 38.3
|
6.7 percentage of participants
Interval 2.2 to 14.9
|
7.7 percentage of participants
Interval 3.1 to 15.2
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4
Joint Pain: Any (n = 16, 83, 99)
|
25.0 percentage of participants
Interval 7.3 to 52.4
|
32.5 percentage of participants
Interval 22.6 to 43.7
|
31.3 percentage of participants
Interval 22.4 to 41.4
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4
Joint Pain: Mild (n = 15, 78, 93)
|
13.3 percentage of participants
Interval 1.7 to 40.5
|
24.4 percentage of participants
Interval 15.3 to 35.4
|
22.6 percentage of participants
Interval 14.6 to 32.4
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4
Joint Pain: Moderate (n = 16, 75, 91)
|
12.5 percentage of participants
Interval 1.6 to 38.3
|
17.3 percentage of participants
Interval 9.6 to 27.8
|
16.5 percentage of participants
Interval 9.5 to 25.7
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4
Joint Pain: Severe (n = 16, 74, 90)
|
6.3 percentage of participants
Interval 0.2 to 30.2
|
4.1 percentage of participants
Interval 0.8 to 11.4
|
4.4 percentage of participants
Interval 1.2 to 11.0
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4
Use of Medication to Treat Pain (n= 16, 77, 93)
|
18.8 percentage of participants
Interval 4.0 to 45.6
|
16.9 percentage of participants
Interval 9.3 to 27.1
|
17.2 percentage of participants
Interval 10.2 to 26.4
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4
Use of Medication to Treat Fever (n= 17, 77, 94)
|
23.5 percentage of participants
Interval 6.8 to 49.9
|
15.6 percentage of participants
Interval 8.3 to 25.6
|
17.0 percentage of participants
Interval 10.1 to 26.2
|
Adverse Events
13vPnC Dose 1 to 13vPnC Dose 3 Blood Draw
Serious events: 58 serious events
Other events: 203 other events
Deaths: 0 deaths
13vPnC Dose 3 Blood Draw to 13vPnC Dose 4
Serious events: 42 serious events
Other events: 89 other events
Deaths: 0 deaths
13vPnC Dose 4
Serious events: 11 serious events
Other events: 127 other events
Deaths: 0 deaths
23vPS Dose
Serious events: 11 serious events
Other events: 93 other events
Deaths: 0 deaths
Follow-up
Serious events: 28 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
13vPnC Dose 1 to 13vPnC Dose 3 Blood Draw
n=247 participants at risk
All participants aged 2 years and above who received 3 single 0.5 mL doses of 13vPnC intramuscular injections at 1-month intervals, were assessed from 13vPnC Dose 1 to the blood draw 1 month after 13vPnC Dose 3.
|
13vPnC Dose 3 Blood Draw to 13vPnC Dose 4
n=221 participants at risk
All participants aged 2 years and above who received 4 single 0.5 mL doses of 13vPnC intramuscular injections, 13vPnC Doses 1 to 3 at 1-month intervals and 13vPnC Dose 4 at 6 months after 13vPnC Dose 3, were assessed from blood draw 1 month after 13vPnC Dose 3 to prior to administration of 13vPnC Dose 4.
|
13vPnC Dose 4
n=192 participants at risk
All participants aged 2 years and above who received 4 single 0.5 mL doses of 13vPnC intramuscular injections, 13vPnC Doses 1 to 3 at 1-month intervals and 13vPnC Dose 4 at 6 months after 13vPnC Dose 3, were assessed from 13vPnC Dose 4 to the blood draw 1 month after 13vPnC Dose 4.
|
23vPS Dose
n=184 participants at risk
All participants aged 2 years and above who received 4 single 0.5 mL doses of 13vPnC intramuscular injections, 13vPnC Doses 1 to 3 at 1-month intervals and 13vPnC Dose 4 at 6 months after 13vPnC Dose 3, followed by single 0.5 mL dose of 23vPS intramuscular injection at 1 month after 13vPnC Dose 4, were assessed from 23vPS Dose to the blood draw 1 month after 23vPS Dose.
|
Follow-up
n=247 participants at risk
All participants aged 2 years and above who received 4 single 0.5 mL doses of 13vPnC intramuscular injections, 13vPnC Doses 1 to 3 at 1-month intervals and 13vPnC Dose 4 at 6 months after 13vPnC Dose 3, followed by single 0.5 mL dose of 23vPS intramuscular injection at 1 month after 13vPnC Dose 4, were assessed from blood draw 1 month after 23vPS Dose to 6-month follow-up.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.81%
2/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.81%
2/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Blood and lymphatic system disorders
Anaemia haemolytic autoimmune
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.81%
2/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Blood and lymphatic system disorders
Warm type haemolytic anaemia
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Cardiac disorders
Pericarditis
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Gastrointestinal disorders
Hernial eventration
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.52%
1/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
General disorders
Pyrexia
|
2.4%
6/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.8%
4/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.6%
4/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
General disorders
Injection site erythema
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
General disorders
Oedema peripheral
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
General disorders
General physical health deterioration
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
General disorders
Death
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.52%
1/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Hepatobiliary disorders
Hepatocellular injury
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Immune system disorders
Graft versus host disease
|
2.0%
5/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.81%
2/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Immune system disorders
Graft versus host disease in intestine
|
0.81%
2/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Immune system disorders
Chronic graft versus host disease
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Immune system disorders
Graft versus host disease in liver
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.1%
2/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Immune system disorders
Graft versus host disease in skin
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.90%
2/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Escherichia sepsis
|
0.81%
2/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.90%
2/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Herpes zoster
|
0.81%
2/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.8%
4/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.52%
1/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.54%
1/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.81%
2/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Pneumonia
|
0.81%
2/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.90%
2/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.52%
1/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.6%
4/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Respiratory tract infection
|
0.81%
2/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.52%
1/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Septic shock
|
0.81%
2/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Appendicitis
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Bacterial sepsis
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.90%
2/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Cerebral toxoplasmosis
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Ear infection
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Enterocolitis viral
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Gastroenteritis
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Gingivitis
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Infection
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.54%
1/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Influenza
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.52%
1/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Klebsiella sepsis
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Molluscum contagiosum
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Pneumonia haemophilus
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Post procedural infection
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Sepsis
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Sinusitis
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.52%
1/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Staphylococcal infection
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.54%
1/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Cytomegalovirus infection
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Haemophilus sepsis
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Hepatic candidiasis
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Hepatitis B
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Herpes virus infection
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Herpes zoster disseminated
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Meningitis
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Pneumonia pseudomonas aeruginosa
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
H1N1 influenza
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.52%
1/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.52%
1/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Streptococcal sepsis
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.52%
1/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Device related infection
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.54%
1/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Thrombophlebitis septic
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.54%
1/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Varicella
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.54%
1/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Pseudomonal sepsis
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Investigations
Cytomegalovirus test positive
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Investigations
False positive investigation result
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.52%
1/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
2.4%
6/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.90%
2/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia recurrent
|
2.4%
6/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.8%
4/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.52%
1/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.2%
3/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia recurrent
|
0.81%
2/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma recurrent
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasmacytoma
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Post transplant lymphoproliferative disorder
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute lymphocytic leukaemia
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
General disorders
Uncoded
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute lymphocytic leukaemia recurrent
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ependymoma
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mantle cell lymphoma
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Refractory anaemia with an excess of blasts
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic myeloid leukaemia
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Nervous system disorders
Guillain-Barre syndrome
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.54%
1/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Juvenile chronic myelomonocytic leukaemia
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Nervous system disorders
Headache
|
0.81%
2/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Nervous system disorders
VIIth nerve paralysis
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.54%
1/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Psychiatric disorders
Alcohol abuse
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Renal and urinary disorders
Renal failure
|
0.81%
2/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Renal and urinary disorders
Renal failure acute
|
0.81%
2/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.90%
2/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.90%
2/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Reproductive system and breast disorders
Epididymitis
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.54%
1/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Vascular disorders
Hypovolaemic shock
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Vascular disorders
Hypotension
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Injury, poisoning and procedural complications
Sternal fracture
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
Other adverse events
| Measure |
13vPnC Dose 1 to 13vPnC Dose 3 Blood Draw
n=247 participants at risk
All participants aged 2 years and above who received 3 single 0.5 mL doses of 13vPnC intramuscular injections at 1-month intervals, were assessed from 13vPnC Dose 1 to the blood draw 1 month after 13vPnC Dose 3.
|
13vPnC Dose 3 Blood Draw to 13vPnC Dose 4
n=221 participants at risk
All participants aged 2 years and above who received 4 single 0.5 mL doses of 13vPnC intramuscular injections, 13vPnC Doses 1 to 3 at 1-month intervals and 13vPnC Dose 4 at 6 months after 13vPnC Dose 3, were assessed from blood draw 1 month after 13vPnC Dose 3 to prior to administration of 13vPnC Dose 4.
|
13vPnC Dose 4
n=192 participants at risk
All participants aged 2 years and above who received 4 single 0.5 mL doses of 13vPnC intramuscular injections, 13vPnC Doses 1 to 3 at 1-month intervals and 13vPnC Dose 4 at 6 months after 13vPnC Dose 3, were assessed from 13vPnC Dose 4 to the blood draw 1 month after 13vPnC Dose 4.
|
23vPS Dose
n=184 participants at risk
All participants aged 2 years and above who received 4 single 0.5 mL doses of 13vPnC intramuscular injections, 13vPnC Doses 1 to 3 at 1-month intervals and 13vPnC Dose 4 at 6 months after 13vPnC Dose 3, followed by single 0.5 mL dose of 23vPS intramuscular injection at 1 month after 13vPnC Dose 4, were assessed from 23vPS Dose to the blood draw 1 month after 23vPS Dose.
|
Follow-up
n=247 participants at risk
All participants aged 2 years and above who received 4 single 0.5 mL doses of 13vPnC intramuscular injections, 13vPnC Doses 1 to 3 at 1-month intervals and 13vPnC Dose 4 at 6 months after 13vPnC Dose 3, followed by single 0.5 mL dose of 23vPS intramuscular injection at 1 month after 13vPnC Dose 4, were assessed from blood draw 1 month after 23vPS Dose to 6-month follow-up.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.0%
5/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.90%
2/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.54%
1/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
1.2%
3/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.81%
2/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Blood and lymphatic system disorders
Aplasia pure red cell
|
0.81%
2/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Blood and lymphatic system disorders
Anaemia macrocytic
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Blood and lymphatic system disorders
Aplastic anaemia
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Blood and lymphatic system disorders
Histiocytosis haematophagic
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.52%
1/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.81%
2/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Blood and lymphatic system disorders
Normochromic normocytic anaemia
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Blood and lymphatic system disorders
Haemolytic uraemic syndrome
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Blood and lymphatic system disorders
Idiopathic thrombocytopenic purpura
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Blood and lymphatic system disorders
Hypergammaglobulinaemia
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.52%
1/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Cardiac disorders
Palpitations
|
0.81%
2/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Cardiac disorders
Arrhythmia
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Cardiac disorders
Atrial thrombosis
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Cardiac disorders
Dilatation ventricular
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Cardiac disorders
Myocardial infarction
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Congenital, familial and genetic disorders
Myotonic dystrophy
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Congenital, familial and genetic disorders
Ichthyosis
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.54%
1/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Ear and labyrinth disorders
Ear pain
|
1.2%
3/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.90%
2/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.1%
2/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Ear and labyrinth disorders
Vertigo
|
1.2%
3/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Ear and labyrinth disorders
Middle ear effusion
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Ear and labyrinth disorders
Tympanic membrane disorder
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Ear and labyrinth disorders
Deafness neurosensory
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Ear and labyrinth disorders
Deafness unilateral
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.54%
1/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Ear and labyrinth disorders
Ear pruritus
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.54%
1/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Endocrine disorders
Cushingoid
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Endocrine disorders
Hyperthyroidism
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Endocrine disorders
Cushing's syndrome
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.52%
1/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Endocrine disorders
Oestrogen deficiency
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.54%
1/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Eye disorders
Conjunctivitis
|
2.4%
6/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.54%
1/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Eye disorders
Dry eye
|
2.0%
5/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.4%
3/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.52%
1/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.1%
2/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Eye disorders
Allergic keratitis
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Eye disorders
Conjunctival hyperaemia
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Eye disorders
Diabetic retinopathy
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Eye disorders
Eye haemorrhage
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Eye disorders
Eye irritation
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Eye disorders
Foreign body sensation in eyes
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Eye disorders
Keratitis
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Eye disorders
Orbital oedema
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Eye disorders
Vision blurred
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Eye disorders
Visual acuity reduced
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.81%
2/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.4%
3/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.52%
1/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Eye disorders
Visual impairment
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.54%
1/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Eye disorders
Vitreous detachment
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.90%
2/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Eye disorders
Blindness
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Eye disorders
Cataract
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.54%
1/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Eye disorders
Periorbital oedema
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Eye disorders
Eye inflammation
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.52%
1/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Eye disorders
Retinal detachment
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.52%
1/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Eye disorders
Xerophthalmia
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.52%
1/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.54%
1/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Gastrointestinal disorders
Diarrhoea
|
9.7%
24/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.90%
2/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.6%
3/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.6%
3/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Gastrointestinal disorders
Vomiting
|
6.1%
15/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.81%
2/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
General disorders
Asthenia
|
4.0%
10/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.90%
2/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.52%
1/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.6%
3/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Gastrointestinal disorders
Nausea
|
3.2%
8/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.54%
1/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.81%
2/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.2%
8/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.0%
2/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.0%
5/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Gastrointestinal disorders
Stomatitis
|
2.0%
5/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.90%
2/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.52%
1/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Gastrointestinal disorders
Constipation
|
1.6%
4/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.90%
2/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.52%
1/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.54%
1/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Gastrointestinal disorders
Dry mouth
|
1.2%
3/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Gastrointestinal disorders
Dysphagia
|
1.2%
3/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.2%
3/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.54%
1/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.81%
2/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.52%
1/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.81%
2/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Gastrointestinal disorders
Aptyalism
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Gastrointestinal disorders
Ascites
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Gastrointestinal disorders
Eructation
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.54%
1/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Gastrointestinal disorders
Faecaloma
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Gastrointestinal disorders
Glossodynia
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Gastrointestinal disorders
Hyperchlorhydria
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Gastrointestinal disorders
Lip swelling
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Gastrointestinal disorders
Oral disorder
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Gastrointestinal disorders
Oral mucosal discolouration
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Gastrointestinal disorders
Oral pain
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.54%
1/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Gastrointestinal disorders
Tongue coated
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Gastrointestinal disorders
Tongue discolouration
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.90%
2/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Gastrointestinal disorders
Oral lichen planus
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.90%
2/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.54%
1/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Gastrointestinal disorders
Sensitivity of teeth
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.52%
1/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.54%
1/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.54%
1/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
General disorders
Fatigue
|
6.1%
15/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.4%
3/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.6%
3/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
2.7%
5/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
General disorders
Pyrexia
|
6.5%
16/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
2.3%
5/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.6%
3/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
4.3%
8/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
General disorders
Oedema peripheral
|
4.9%
12/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
2.7%
6/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.1%
2/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
General disorders
Injection site swelling
|
1.6%
4/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.6%
3/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
4.3%
8/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
General disorders
Injection site erythema
|
1.2%
3/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
2.1%
4/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
2.7%
5/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
General disorders
Oedema
|
1.2%
3/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
General disorders
Chest pain
|
0.81%
2/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.52%
1/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
General disorders
Catheter site rash
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
General disorders
Chest discomfort
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.54%
1/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
General disorders
Complication of device removal
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
General disorders
Feeling cold
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.52%
1/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
General disorders
Feeling hot
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
General disorders
Gait disturbance
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
General disorders
Influenza like illness
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.52%
1/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
General disorders
Injection site movement impairment
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
General disorders
Injection site pain
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
2.6%
5/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
4.3%
8/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
General disorders
Medical device complication
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
General disorders
Pain
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
General disorders
Vaccination site haematoma
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.52%
1/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
General disorders
Vaccination site pain
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
3.3%
6/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
General disorders
Vaccination site reaction
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
2.2%
4/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
General disorders
Inflammation
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
General disorders
Spinal pain
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
General disorders
Chills
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.52%
1/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.54%
1/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
General disorders
Injection site pruritus
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.52%
1/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
General disorders
Injection site reaction
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.52%
1/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.54%
1/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.52%
1/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
General disorders
Vaccination site erythema
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
2.7%
5/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
General disorders
Vaccination site swelling
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
2.2%
4/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
General disorders
Injection site induration
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.54%
1/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
General disorders
Injection site inflammation
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.54%
1/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
General disorders
Vaccination site oedema
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.54%
1/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
General disorders
Vaccination site rash
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.54%
1/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
General disorders
Hernia
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
1.2%
3/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Hepatobiliary disorders
Hepatocellular injury
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.54%
1/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Immune system disorders
Graft versus host disease
|
8.5%
21/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
3.6%
8/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.0%
2/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
2.2%
4/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Immune system disorders
Chronic graft versus host disease
|
4.9%
12/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.4%
3/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.6%
3/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Immune system disorders
Graft versus host disease in liver
|
2.0%
5/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.54%
1/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Immune system disorders
Graft versus host disease in skin
|
1.6%
4/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
2.7%
6/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Immune system disorders
Food allergy
|
0.81%
2/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.52%
1/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Immune system disorders
Hypogammaglobulinaemia
|
0.81%
2/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Immune system disorders
Acute graft versus host disease
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Immune system disorders
Chronic graft versus host disease in liver
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Immune system disorders
Graft versus host disease in intestine
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.90%
2/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Nasopharyngitis
|
11.3%
28/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
2.7%
6/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
5.7%
11/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
4.9%
9/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Cytomegalovirus infection
|
4.0%
10/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.4%
3/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.52%
1/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Upper respiratory tract infection
|
4.0%
10/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
2.7%
6/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.6%
3/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.6%
3/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Herpes zoster
|
3.2%
8/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
2.3%
5/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.54%
1/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.81%
2/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Bronchitis
|
2.4%
6/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.4%
3/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.52%
1/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.1%
2/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Sinusitis
|
2.0%
5/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.1%
2/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Tonsillitis
|
2.0%
5/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.52%
1/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Urinary tract infection
|
1.6%
4/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.90%
2/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Oral fungal infection
|
1.6%
4/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Rhinitis
|
1.6%
4/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.4%
3/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.1%
2/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Escherichia infection
|
0.81%
2/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Gastroenteritis
|
0.81%
2/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Oral candidiasis
|
0.81%
2/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.6%
3/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Oral herpes
|
1.2%
3/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.8%
4/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.52%
1/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.54%
1/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Candidiasis
|
0.81%
2/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Enterobacter sepsis
|
0.81%
2/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Escherichia sepsis
|
0.81%
2/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Eye infection
|
0.81%
2/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Otitis media
|
0.81%
2/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.1%
2/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Pharyngitis
|
0.81%
2/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.52%
1/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.1%
2/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.81%
2/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Respiratory tract infection
|
0.81%
2/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.54%
1/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Viral infection
|
0.81%
2/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Adenovirus infection
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Aspergillosis
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Bacterial infection
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Catheter site infection
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Conjunctivitis viral
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.52%
1/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Enterobacter infection
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Enterococcal sepsis
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Epstein-Barr virus infection
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.52%
1/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Febrile infection
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Folliculitis
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Fungal infection
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.52%
1/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Gastroenteritis viral
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.54%
1/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Genital infection fungal
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Herpes simplex
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.52%
1/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Infection
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.52%
1/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Influenza
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.4%
3/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.54%
1/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Laryngitis
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Mycoplasma infection
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Pseudomonas infection
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Respiratory moniliasis
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Systemic candida
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.90%
2/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Bronchitis viral
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Hepatitis B
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Herpes zoster oticus
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Oesophageal candidiasis
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Periorbital cellulitis
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Sepsis
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Streptococcal urinary tract infection
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Viral pharyngitis
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.0%
2/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Herpes virus infection
|
4.0%
10/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.52%
1/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Infected dermal cyst
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.52%
1/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Lung infection
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.52%
1/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.54%
1/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Pharyngotonsillitis
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.52%
1/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Toxoplasmosis
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.52%
1/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Viral rhinitis
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.52%
1/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Ear infection
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.54%
1/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.54%
1/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Injection site cellulitis
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.54%
1/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Trichosporon infection
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
0.81%
2/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.81%
2/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.81%
2/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.54%
1/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Injury, poisoning and procedural complications
Eye injury
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Injury, poisoning and procedural complications
Fall
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Injury, poisoning and procedural complications
Febrile nonhaemolytic transfusion reaction
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Injury, poisoning and procedural complications
Conjunctival scar
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Injury, poisoning and procedural complications
Drug administration error
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.52%
1/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.54%
1/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Investigations
Blood testosterone decreased
|
0.81%
2/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Investigations
Liver function test abnormal
|
0.81%
2/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.52%
1/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Investigations
Neutrophil count decreased
|
0.81%
2/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Investigations
Weight decreased
|
0.81%
2/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.52%
1/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.6%
3/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Investigations
Alanine aminotransferase increased
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Investigations
Blood potassium decreased
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Investigations
C-reactive protein increased
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Investigations
Human herpes virus 6 serology positive
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Investigations
Intraocular pressure increased
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Investigations
Thyroxine decreased
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Investigations
Serum ferritin increased
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.90%
2/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.52%
1/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Investigations
Cystogram
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Investigations
Ejection fraction abnormal
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.54%
1/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.54%
1/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Investigations
Body temperature increased
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.54%
1/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Investigations
Transaminases increased
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.54%
1/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.8%
7/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.54%
1/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Metabolism and nutrition disorders
Fluid retention
|
1.2%
3/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
1.2%
3/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.6%
3/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.81%
2/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.81%
2/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.81%
2/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Metabolism and nutrition disorders
Folate deficiency
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Metabolism and nutrition disorders
Hypercreatininaemia
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.52%
1/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Metabolism and nutrition disorders
Vitamin K deficiency
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Metabolism and nutrition disorders
Haemochromatosis
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.52%
1/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.52%
1/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.54%
1/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.54%
1/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.5%
11/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
2.7%
6/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
2.1%
4/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.6%
3/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.81%
2/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.8%
7/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.90%
2/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.0%
2/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.54%
1/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.8%
7/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.1%
2/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.0%
5/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.52%
1/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.6%
3/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.6%
4/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.90%
2/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.2%
3/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.52%
1/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.1%
2/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.52%
1/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.4%
3/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.90%
2/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Musculoskeletal and connective tissue disorders
Sjogren's syndrome
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.52%
1/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasmacytoma
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Precursor B-lymphoblastic lymphoma
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute leukaemia
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia recurrent
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Kaposi's sarcoma
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anogenital warts
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.52%
1/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Nervous system disorders
Headache
|
5.3%
13/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.4%
3/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
2.1%
4/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.6%
3/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Nervous system disorders
Dysgeusia
|
1.2%
3/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Nervous system disorders
Balance disorder
|
0.81%
2/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Nervous system disorders
Dizziness
|
0.81%
2/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.54%
1/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Nervous system disorders
Paraesthesia
|
0.81%
2/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.90%
2/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Nervous system disorders
Coordination abnormal
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Nervous system disorders
Hyperaesthesia
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Nervous system disorders
Myoclonus
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Nervous system disorders
Nervous system disorder
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Nervous system disorders
Polyneuropathy
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.52%
1/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Nervous system disorders
Post herpetic neuralgia
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.54%
1/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Nervous system disorders
Sciatica
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Nervous system disorders
Sinus headache
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Nervous system disorders
Migraine with aura
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Nervous system disorders
Syncope
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.52%
1/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Nervous system disorders
Cranial nerve palsies multiple
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.54%
1/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.54%
1/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.54%
1/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Psychiatric disorders
Anxiety
|
2.0%
5/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Psychiatric disorders
Insomnia
|
1.6%
4/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.52%
1/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Psychiatric disorders
Sleep disorder
|
0.81%
2/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.52%
1/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Psychiatric disorders
Confusional state
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Psychiatric disorders
Nervousness
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Psychiatric disorders
Stress
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Psychiatric disorders
Depression
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.1%
2/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Renal and urinary disorders
Polyuria
|
0.81%
2/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Renal and urinary disorders
Renal failure
|
1.2%
3/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Renal and urinary disorders
Dysuria
|
0.81%
2/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Renal and urinary disorders
Nocturia
|
0.81%
2/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Renal and urinary disorders
Pollakiuria
|
0.81%
2/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Renal and urinary disorders
Haematuria
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.52%
1/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Renal and urinary disorders
Incontinence
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Renal and urinary disorders
Renal impairment
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Renal and urinary disorders
Urethral pain
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Renal and urinary disorders
Urinary retention
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Renal and urinary disorders
Urinary tract disorder
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.54%
1/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Renal and urinary disorders
Urine abnormality
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.54%
1/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.54%
1/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Reproductive system and breast disorders
Vulvovaginal discomfort
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Reproductive system and breast disorders
Vulvovaginal dryness
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.54%
1/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Reproductive system and breast disorders
Genital discharge
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Reproductive system and breast disorders
Amenorrhoea
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.52%
1/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.7%
24/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.90%
2/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
2.1%
4/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
3.8%
7/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.81%
2/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
1.6%
4/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.52%
1/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
1.6%
4/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.0%
2/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.6%
3/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal plaque
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.90%
2/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Respiratory, thoracic and mediastinal disorders
Rhonchi
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Respiratory, thoracic and mediastinal disorders
Sputum discoloured
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.54%
1/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Vascular disorders
Hypertension
|
2.8%
7/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.81%
2/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal oedema
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.7%
14/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.0%
2/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.1%
2/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.5%
11/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.90%
2/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.52%
1/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.54%
1/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
2.0%
5/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.54%
1/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
1.6%
4/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.54%
1/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
1.2%
3/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.54%
1/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
1.2%
3/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.81%
2/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.81%
2/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.81%
2/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Skin and subcutaneous tissue disorders
Dermatosis
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Skin and subcutaneous tissue disorders
Generalised erythema
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Skin and subcutaneous tissue disorders
Lichenification
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.52%
1/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Skin and subcutaneous tissue disorders
Perivascular dermatitis
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Skin and subcutaneous tissue disorders
Acute febrile neutrophilic dermatosis
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.54%
1/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Skin and subcutaneous tissue disorders
Pityriasis rubra pilaris
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.52%
1/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.52%
1/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.54%
1/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Skin and subcutaneous tissue disorders
Intertrigo
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.54%
1/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.54%
1/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.54%
1/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Vascular disorders
Hypotension
|
0.81%
2/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.52%
1/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Vascular disorders
Orthostatic hypotension
|
0.81%
2/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Vascular disorders
Thrombophlebitis
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Vascular disorders
Flushing
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Vascular disorders
Hypovolaemic shock
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Vascular disorders
Vasodilatation
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Vascular disorders
Venous insufficiency
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Vascular disorders
Venous thrombosis
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Vascular disorders
Hot flush
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Vascular disorders
Haematoma
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.54%
1/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Vascular disorders
Vena cava thrombosis
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Skin and subcutaneous tissue disorders
Redness (Any)
|
14.2%
17/120 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Skin and subcutaneous tissue disorders
Redness (Mild)
|
11.0%
13/118 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Skin and subcutaneous tissue disorders
Redness (Moderate)
|
5.1%
6/117 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Skin and subcutaneous tissue disorders
Redness (Severe)
|
1.7%
2/116 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Skin and subcutaneous tissue disorders
Swelling (Any)
|
14.9%
18/121 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Skin and subcutaneous tissue disorders
Swelling (Mild)
|
12.5%
15/120 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Skin and subcutaneous tissue disorders
Swelling (Moderate)
|
4.3%
5/117 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Skin and subcutaneous tissue disorders
Swelling (Severe)
|
0.00%
0/126 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Skin and subcutaneous tissue disorders
Pain (Severe)
|
4.3%
5/117 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Skin and subcutaneous tissue disorders
Pain (Any)
|
72.6%
127/175 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Skin and subcutaneous tissue disorders
Pain (Mild)
|
66.9%
109/163 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Skin and subcutaneous tissue disorders
Pain (Moderate)
|
29.8%
42/141 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
General disorders
Fever >=38 degrees C
|
6.7%
8/120 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
General disorders
Fever >=38, <38.5 degrees C
|
5.0%
6/119 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
General disorders
Fever >=38.5, <39 degrees C
|
3.4%
4/117 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
General disorders
Fever >=39, =<40 degrees C
|
1.7%
2/116 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
General disorders
Fatigue (Any)
|
49.0%
77/157 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
General disorders
Fatigue (Mild)
|
40.4%
63/156 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
General disorders
Fatigue (Moderate)
|
30.7%
42/137 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
General disorders
Fatigue (Severe)
|
6.7%
8/120 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
General disorders
Headache (Any)
|
37.3%
53/142 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
General disorders
Headache (Mild)
|
31.9%
44/138 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
General disorders
Headache (Moderate)
|
17.2%
21/122 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
General disorders
Headache (Severe)
|
3.4%
4/119 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
General disorders
Vomiting (Any)
|
10.8%
13/120 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
General disorders
Vomiting (Mild)
|
5.0%
6/119 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
General disorders
Vomiting (Moderate)
|
6.8%
8/117 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
General disorders
Vomiting (Severe)
|
0.00%
0/115 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
General disorders
Diarrhea (Any)
|
23.1%
30/130 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
General disorders
Diarrhea (Mild)
|
20.3%
26/128 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
General disorders
Diarrhea (Moderate)
|
5.0%
6/119 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
General disorders
Diarrhea (Severe)
|
1.7%
2/117 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
General disorders
Muscle pain (Any)
|
40.1%
61/152 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
General disorders
Muscle pain (Mild)
|
33.1%
47/142 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
General disorders
Muscle pain (Moderate)
|
20.5%
27/132 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
General disorders
Muscle pain (Severe)
|
3.4%
4/118 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
General disorders
Joint pain (Any)
|
21.2%
28/132 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
General disorders
Joint pain (Mild)
|
18.0%
23/128 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
General disorders
Joint pain (Moderate)
|
10.7%
13/122 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
General disorders
Joint pain (Severe)
|
3.4%
4/119 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Skin and subcutaneous tissue disorders
Fatigue (Mild)
|
39.2%
58/148 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
General disorders
Fever >40 degrees C
|
0.00%
0/115 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Hepatobiliary disorders
Cholestasis
|
2.0%
5/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Rash pustular
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.40%
1/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.45%
1/221 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/192 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/184 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/247 • AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
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