Trial Outcomes & Findings for Safety and Immunogenicity of 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) in HIV-Infected Subjects 6 Years of Age or Older Who Are Naive to Pneumococcal Vaccine (NCT NCT00962780)
NCT ID: NCT00962780
Last Updated: 2014-11-17
Results Overview
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 2 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 1 month after 13vPnC Dose 2 and after 13vPnC Dose 3 blood draws.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
303 participants
Primary outcome timeframe
1 month after 13vPnC Dose 2, 1 month after 13vPnC Dose 3
Results posted on
2014-11-17
Participant Flow
Participant milestones
| Measure |
13vPnC, 23vPS (Pediatric Participants)
Participants older than or equal to \[\>=\] 6 to less than \[\<\] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
|
13vPnC, 23vPS (Adult Participants)
Participants \>=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
|
|---|---|---|
|
Overall Study
STARTED
|
151
|
152
|
|
Overall Study
Vaccinated 13vPnC Dose 1
|
150
|
151
|
|
Overall Study
Vaccinated 13vPnC Dose 2
|
145
|
145
|
|
Overall Study
Vaccinated 13vPnC Dose 3
|
144
|
142
|
|
Overall Study
Vaccinated 23vPS Dose
|
143
|
139
|
|
Overall Study
COMPLETED
|
141
|
138
|
|
Overall Study
NOT COMPLETED
|
10
|
14
|
Reasons for withdrawal
| Measure |
13vPnC, 23vPS (Pediatric Participants)
Participants older than or equal to \[\>=\] 6 to less than \[\<\] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
|
13vPnC, 23vPS (Adult Participants)
Participants \>=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
|
|---|---|---|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Protocol Violation
|
9
|
4
|
|
Overall Study
Withdrawal by Subject
|
1
|
8
|
|
Overall Study
Other
|
0
|
1
|
Baseline Characteristics
Safety and Immunogenicity of 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) in HIV-Infected Subjects 6 Years of Age or Older Who Are Naive to Pneumococcal Vaccine
Baseline characteristics by cohort
| Measure |
13vPnC, 23vPS (Pediatric Participants)
n=150 Participants
Participants older than or equal to \[\>=\] 6 to less than \[\<\] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
|
13vPnC, 23vPS (Adult Participants)
n=151 Participants
Participants \>=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
|
Total
n=301 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
10.3 years
STANDARD_DEVIATION 3.04 • n=5 Participants
|
41.2 years
STANDARD_DEVIATION 8.45 • n=7 Participants
|
25.8 years
STANDARD_DEVIATION 16.72 • n=5 Participants
|
|
Sex: Female, Male
Female
|
76 Participants
n=5 Participants
|
88 Participants
n=7 Participants
|
164 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
74 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
137 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 month after 13vPnC Dose 2, 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 1 month after 13vPnC Dose 2 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 1 month after 13vPnC Dose 2 and after 13vPnC Dose 3 blood draws.
Outcome measures
| Measure |
13vPnC, 23vPS (All Participants)
n=259 Participants
Participants \>=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
|
13vPnC, 23vPS (Adult Participants)
Participants \>=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
|
13vPnC, 23vPS (All Participants)
Participants \>=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
|
|---|---|---|---|
|
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in All Participants
Serotype 4 (n = 257)
|
1.09 fold rise
Interval 1.03 to 1.14
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in All Participants
Serotype 7F (n = 259)
|
1.10 fold rise
Interval 1.05 to 1.16
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in All Participants
Serotype 19A (n = 259)
|
0.99 fold rise
Interval 0.96 to 1.03
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in All Participants
Serotype 23F (n = 258)
|
1.09 fold rise
Interval 1.03 to 1.15
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in All Participants
Serotype 1 (n = 248)
|
1.03 fold rise
Interval 0.99 to 1.07
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in All Participants
Serotype 3 (n = 238)
|
1.05 fold rise
Interval 1.0 to 1.1
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in All Participants
Serotype 5 (n = 257)
|
1.01 fold rise
Interval 0.97 to 1.05
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in All Participants
Serotype 6A (n = 249)
|
1.02 fold rise
Interval 0.97 to 1.07
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in All Participants
Serotype 6B (n = 257)
|
1.04 fold rise
Interval 1.01 to 1.08
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in All Participants
Serotype 9V (n = 259)
|
1.05 fold rise
Interval 1.01 to 1.09
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in All Participants
Serotype 14 (n = 259)
|
1.04 fold rise
Interval 1.0 to 1.09
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in All Participants
Serotype 18C (n = 259)
|
0.99 fold rise
Interval 0.96 to 1.02
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in All Participants
Serotype 19F (n = 252)
|
1.06 fold rise
Interval 1.01 to 1.11
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 month after 13vPnC Dose 2, 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 both 1 month after 13vPnC Dose 2 and after 13vPnC Dose 3 blood draws. CI for GMC were 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=128 Participants
Participants \>=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
|
13vPnC, 23vPS (Adult Participants)
n=131 Participants
Participants \>=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
|
13vPnC, 23vPS (All Participants)
n=259 Participants
Participants \>=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
|
|---|---|---|---|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants
Serotype 5: 13vPnC Dose 2 (n = 126, 131, 257)
|
4.52 microgram per milliliter (mcg/mL)
Interval 3.78 to 5.39
|
5.77 microgram per milliliter (mcg/mL)
Interval 4.83 to 6.89
|
5.12 microgram per milliliter (mcg/mL)
Interval 4.51 to 5.8
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants
Serotype 23F: 13vPnC Dose 2 (n = 127, 131, 258)
|
6.45 microgram per milliliter (mcg/mL)
Interval 5.3 to 7.85
|
6.10 microgram per milliliter (mcg/mL)
Interval 4.86 to 7.66
|
6.27 microgram per milliliter (mcg/mL)
Interval 5.4 to 7.28
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants
Serotype 1: 13vPnC Dose 2 (n = 120, 128, 248)
|
3.88 microgram per milliliter (mcg/mL)
Interval 3.3 to 4.57
|
3.95 microgram per milliliter (mcg/mL)
Interval 3.23 to 4.85
|
3.92 microgram per milliliter (mcg/mL)
Interval 3.44 to 4.46
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants
Serotype 1: 13vPnC Dose 3 (n = 120, 128, 248)
|
4.14 microgram per milliliter (mcg/mL)
Interval 3.56 to 4.83
|
3.92 microgram per milliliter (mcg/mL)
Interval 3.21 to 4.79
|
4.03 microgram per milliliter (mcg/mL)
Interval 3.55 to 4.57
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants
Serotype 3: 13vPnC Dose 2 (n = 118, 120, 238)
|
1.47 microgram per milliliter (mcg/mL)
Interval 1.25 to 1.74
|
0.97 microgram per milliliter (mcg/mL)
Interval 0.81 to 1.16
|
1.19 microgram per milliliter (mcg/mL)
Interval 1.05 to 1.35
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants
Serotype 3: 13vPnC Dose 3 (n = 118, 120, 238)
|
1.49 microgram per milliliter (mcg/mL)
Interval 1.26 to 1.76
|
1.06 microgram per milliliter (mcg/mL)
Interval 0.88 to 1.27
|
1.25 microgram per milliliter (mcg/mL)
Interval 1.11 to 1.42
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants
Serotype 4: 13vPnC Dose 2 (n = 127, 130, 257)
|
3.06 microgram per milliliter (mcg/mL)
Interval 2.54 to 3.69
|
2.97 microgram per milliliter (mcg/mL)
Interval 2.4 to 3.67
|
3.01 microgram per milliliter (mcg/mL)
Interval 2.62 to 3.47
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants
Serotype 4: 13vPnC Dose 3 (n = 127, 130, 257)
|
3.36 microgram per milliliter (mcg/mL)
Interval 2.84 to 3.97
|
3.19 microgram per milliliter (mcg/mL)
Interval 2.59 to 3.91
|
3.27 microgram per milliliter (mcg/mL)
Interval 2.87 to 3.73
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants
Serotype 5: 13vPnC Dose 3 (n = 126, 131, 257)
|
4.84 microgram per milliliter (mcg/mL)
Interval 4.12 to 5.7
|
5.53 microgram per milliliter (mcg/mL)
Interval 4.63 to 6.61
|
5.18 microgram per milliliter (mcg/mL)
Interval 4.6 to 5.85
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants
Serotype 6A: 13vPnC Dose 2 (n = 119, 130, 249)
|
7.66 microgram per milliliter (mcg/mL)
Interval 6.46 to 9.08
|
7.03 microgram per milliliter (mcg/mL)
Interval 5.71 to 8.67
|
7.33 microgram per milliliter (mcg/mL)
Interval 6.4 to 8.39
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants
Serotype 6A: 13vPnC Dose 3 (n = 119, 130, 249)
|
7.97 microgram per milliliter (mcg/mL)
Interval 6.81 to 9.33
|
7.04 microgram per milliliter (mcg/mL)
Interval 5.74 to 8.64
|
7.47 microgram per milliliter (mcg/mL)
Interval 6.56 to 8.51
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants
Serotype 6B: 13vPnC Dose 2 (n = 127, 130, 257)
|
11.43 microgram per milliliter (mcg/mL)
Interval 9.45 to 13.84
|
7.93 microgram per milliliter (mcg/mL)
Interval 6.51 to 9.65
|
9.50 microgram per milliliter (mcg/mL)
Interval 8.28 to 10.91
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants
Serotype 6B: 13vPnC Dose 3 (n = 127, 130, 257)
|
11.94 microgram per milliliter (mcg/mL)
Interval 10.01 to 14.24
|
8.28 microgram per milliliter (mcg/mL)
Interval 6.78 to 10.11
|
9.92 microgram per milliliter (mcg/mL)
Interval 8.67 to 11.35
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants
Serotype 7F: 13vPnC Dose 2 (n = 128, 131, 259)
|
4.25 microgram per milliliter (mcg/mL)
Interval 3.67 to 4.92
|
5.78 microgram per milliliter (mcg/mL)
Interval 4.81 to 6.95
|
4.96 microgram per milliliter (mcg/mL)
Interval 4.41 to 5.59
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants
Serotype 7F: 13vPnC Dose 3 (n = 128, 131, 259)
|
5.05 microgram per milliliter (mcg/mL)
Interval 4.38 to 5.82
|
5.90 microgram per milliliter (mcg/mL)
Interval 4.95 to 7.04
|
5.46 microgram per milliliter (mcg/mL)
Interval 4.88 to 6.12
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants
Serotype 9V: 13vPnC Dose 2 (n = 128, 131, 259)
|
4.81 microgram per milliliter (mcg/mL)
Interval 4.18 to 5.54
|
5.14 microgram per milliliter (mcg/mL)
Interval 4.27 to 6.19
|
4.98 microgram per milliliter (mcg/mL)
Interval 4.43 to 5.59
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants
Serotype 9V: 13vPnC Dose 3 (n = 128, 131, 259)
|
4.98 microgram per milliliter (mcg/mL)
Interval 4.35 to 5.7
|
5.48 microgram per milliliter (mcg/mL)
Interval 4.59 to 6.55
|
5.23 microgram per milliliter (mcg/mL)
Interval 4.67 to 5.84
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants
Serotype 14: 13vPnC Dose 2 (n = 128, 131, 259)
|
11.60 microgram per milliliter (mcg/mL)
Interval 8.76 to 15.35
|
15.14 microgram per milliliter (mcg/mL)
Interval 11.64 to 19.71
|
13.27 microgram per milliliter (mcg/mL)
Interval 10.96 to 16.08
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants
Serotype 14: 13vPnC Dose 3 (n = 128, 131, 259)
|
12.62 microgram per milliliter (mcg/mL)
Interval 9.75 to 16.33
|
15.13 microgram per milliliter (mcg/mL)
Interval 11.8 to 19.4
|
13.83 microgram per milliliter (mcg/mL)
Interval 11.57 to 16.53
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants
Serotype 18C: 13vPnC Dose 2 (n = 128, 131, 259)
|
3.79 microgram per milliliter (mcg/mL)
Interval 3.12 to 4.6
|
5.33 microgram per milliliter (mcg/mL)
Interval 4.34 to 6.54
|
4.50 microgram per milliliter (mcg/mL)
Interval 3.91 to 5.19
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants
Serotype 18C: 13vPnC Dose 3 (n = 128, 131, 259)
|
3.83 microgram per milliliter (mcg/mL)
Interval 3.19 to 4.6
|
5.18 microgram per milliliter (mcg/mL)
Interval 4.27 to 6.28
|
4.46 microgram per milliliter (mcg/mL)
Interval 3.9 to 5.1
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants
Serotype 19A: 13vPnC Dose 2 (n = 128, 131, 259)
|
14.38 microgram per milliliter (mcg/mL)
Interval 12.2 to 16.96
|
13.19 microgram per milliliter (mcg/mL)
Interval 11.06 to 15.75
|
13.77 microgram per milliliter (mcg/mL)
Interval 12.21 to 15.53
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants
Serotype 19A: 13vPnC Dose 3 (n = 128, 131, 259)
|
14.19 microgram per milliliter (mcg/mL)
Interval 12.17 to 16.54
|
13.18 microgram per milliliter (mcg/mL)
Interval 11.11 to 15.62
|
13.67 microgram per milliliter (mcg/mL)
Interval 12.2 to 15.32
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants
Serotype 19F: 13vPnC Dose 2 (n = 124, 128, 252)
|
5.78 microgram per milliliter (mcg/mL)
Interval 4.63 to 7.21
|
5.34 microgram per milliliter (mcg/mL)
Interval 4.17 to 6.84
|
5.55 microgram per milliliter (mcg/mL)
Interval 4.71 to 6.55
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants
Serotype 19F: 13vPnC Dose 3 (n = 124, 128, 252)
|
6.09 microgram per milliliter (mcg/mL)
Interval 4.98 to 7.44
|
5.67 microgram per milliliter (mcg/mL)
Interval 4.47 to 7.18
|
5.87 microgram per milliliter (mcg/mL)
Interval 5.03 to 6.85
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants
Serotype 23F: 13vPnC Dose 3 (n = 127, 131, 258)
|
6.64 microgram per milliliter (mcg/mL)
Interval 5.55 to 7.94
|
7.06 microgram per milliliter (mcg/mL)
Interval 5.65 to 8.82
|
6.85 microgram per milliliter (mcg/mL)
Interval 5.94 to 7.9
|
SECONDARY outcome
Timeframe: 1 month after 13vPnC Dose 2, 1 month after 13vPnC Dose 3Population: Evaluable immunogenicity population. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure and "n" signifies participants with valid and determinate assay results for specified serotype at both 1 month after 13vPnC Dose 2 and after 13vPnC Dose 3 blood draws for each treatment arm, respectively.
Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of pediatric, adult and all participants using a microcolony OPA (mcOPA) assay. GMT (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data for both 1 month after 13vPnC Dose 2 and after 13vPnC Dose 3 blood draws. CI for GMT were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
Outcome measures
| Measure |
13vPnC, 23vPS (All Participants)
n=127 Participants
Participants \>=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
|
13vPnC, 23vPS (Adult Participants)
n=129 Participants
Participants \>=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
|
13vPnC, 23vPS (All Participants)
n=256 Participants
Participants \>=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
|
|---|---|---|---|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants
Serotype 6A: 13vPnC Dose 2 (n = 125, 124, 249)
|
5560 titers
Interval 4378.4 to 7060.9
|
2425 titers
Interval 1790.7 to 3284.5
|
3678 titers
Interval 3016.2 to 4485.6
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants
Serotype 23F: 13vPnC Dose 3 (n = 120, 126, 246)
|
2327 titers
Interval 1844.2 to 2935.9
|
671 titers
Interval 449.8 to 1000.3
|
1231 titers
Interval 963.0 to 1572.5
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants
Serotype 1: 13vPnC Dose 3 (n = 126, 127, 253)
|
69 titers
Interval 51.6 to 91.4
|
69 titers
Interval 51.3 to 92.0
|
69 titers
Interval 56.1 to 84.1
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants
Serotype 1: 13vPnC Dose 2 (n = 126, 127, 253)
|
51 titers
Interval 37.2 to 70.0
|
54 titers
Interval 38.7 to 74.2
|
52 titers
Interval 41.8 to 65.5
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants
Serotype 3: 13vPnC Dose 2 (n = 127, 129, 256)
|
81 titers
Interval 64.1 to 102.0
|
48 titers
Interval 37.9 to 61.5
|
62 titers
Interval 52.6 to 73.9
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants
Serotype 3: 13vPnC Dose 3 (n = 127, 129, 256)
|
114 titers
Interval 94.5 to 137.8
|
79 titers
Interval 62.1 to 99.9
|
95 titers
Interval 81.3 to 110.3
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants
Serotype 4: 13vPnC Dose 2 (n = 117, 126, 243)
|
2509 titers
Interval 1922.3 to 3274.2
|
1620 titers
Interval 1211.2 to 2167.4
|
2000 titers
Interval 1639.8 to 2439.1
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants
Serotype 4: 13vPnC Dose 3 (n = 117, 126, 243)
|
3246 titers
Interval 2697.1 to 3906.3
|
1944 titers
Interval 1465.3 to 2579.7
|
2488 titers
Interval 2092.1 to 2959.8
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants
Serotype 5: 13vPnC Dose 2 (n = 122, 124, 246)
|
159 titers
Interval 109.2 to 232.2
|
104 titers
Interval 69.1 to 156.9
|
129 titers
Interval 97.3 to 169.7
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants
Serotype 5: 13vPnC Dose 3 (n = 122, 124, 246)
|
267 titers
Interval 191.3 to 371.5
|
142 titers
Interval 97.5 to 206.7
|
194 titers
Interval 150.8 to 249.7
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants
Serotype 6A: 13vPnC Dose 3 (n = 125, 124, 249)
|
7758 titers
Interval 6314.2 to 9531.2
|
3239 titers
Interval 2488.5 to 4215.9
|
5022 titers
Interval 4216.8 to 5979.9
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants
Serotype 6B: 13vPnC Dose 2 (n = 121, 128, 249)
|
5449 titers
Interval 4365.1 to 6801.1
|
2724 titers
Interval 2004.8 to 3701.0
|
3815 titers
Interval 3140.9 to 4634.1
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants
Serotype 6B: 13vPnC Dose 3 (n = 121, 128, 249)
|
7151 titers
Interval 5828.2 to 8773.9
|
3723 titers
Interval 2771.1 to 5002.5
|
5113 titers
Interval 4250.1 to 6150.5
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants
Serotype 7F: 13vPnC Dose 2 (n = 125, 127, 252)
|
3494 titers
Interval 2772.8 to 4403.3
|
2255 titers
Interval 1739.6 to 2923.6
|
2802 titers
Interval 2352.6 to 3338.0
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants
Serotype 7F: 13vPnC Dose 3 (n = 125, 127, 252)
|
4638 titers
Interval 3889.7 to 5529.4
|
2702 titers
Interval 2130.3 to 3428.2
|
3533 titers
Interval 3037.4 to 4108.5
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants
Serotype 9V: 13vPnC Dose 2 (n = 118, 127, 245)
|
3339 titers
Interval 2461.4 to 4530.3
|
1432 titers
Interval 998.6 to 2054.9
|
2153 titers
Interval 1690.3 to 2743.3
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants
Serotype 9V: 13vPnC Dose 3 (n = 118, 127, 245)
|
4714 titers
Interval 3731.5 to 5955.4
|
2004 titers
Interval 1416.5 to 2836.1
|
3026 titers
Interval 2434.3 to 3761.4
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants
Serotype 14: 13vPnC Dose 2 (n = 117, 127, 244)
|
3704 titers
Interval 2906.5 to 4719.5
|
1342 titers
Interval 1010.1 to 1782.1
|
2183 titers
Interval 1792.2 to 2659.6
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants
Serotype 14: 13vPnC Dose 3 (n = 117, 127, 244)
|
3963 titers
Interval 3195.8 to 4914.2
|
1480 titers
Interval 1150.3 to 1903.9
|
2373 titers
Interval 1988.4 to 2832.8
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants
Serotype 18C: 13vPnC Dose 2 (n = 117, 121, 238)
|
4635 titers
Interval 3609.7 to 5951.8
|
1349 titers
Interval 947.0 to 1921.5
|
2475 titers
Interval 1965.7 to 3115.4
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants
Serotype 18C: 13vPnC Dose 3 (n = 117, 121, 238)
|
5579 titers
Interval 4423.7 to 7036.9
|
1787 titers
Interval 1272.8 to 2508.5
|
3127 titers
Interval 2515.2 to 3888.6
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants
Serotype 19A: 13vPnC Dose 2 (n = 125, 127, 252)
|
684 titers
Interval 519.2 to 902.1
|
458 titers
Interval 332.5 to 631.2
|
559 titers
Interval 452.3 to 690.9
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants
Serotype 19A: 13vPnC Dose 3 (n = 125, 127, 252)
|
1002 titers
Interval 814.5 to 1232.3
|
613 titers
Interval 465.6 to 806.4
|
782 titers
Interval 657.2 to 930.5
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants
Serotype 19F: 13vPnC Dose 2 (n = 122, 118, 240)
|
717 titers
Interval 495.6 to 1036.7
|
315 titers
Interval 196.7 to 506.0
|
479 titers
Interval 354.4 to 646.9
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants
Serotype 19F: 13vPnC Dose 3 (n = 122, 118, 240)
|
1152 titers
Interval 864.2 to 1535.0
|
597 titers
Interval 397.9 to 897.1
|
834 titers
Interval 650.1 to 1070.2
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants
Serotype 23F: 13vPnC Dose 2 (n = 120, 126, 246)
|
1477 titers
Interval 1086.2 to 2008.2
|
409 titers
Interval 271.9 to 614.0
|
765 titers
Interval 585.2 to 999.4
|
SECONDARY outcome
Timeframe: 1 month after 13vPnC Dose 2, 1 month after 13vPnC Dose 3Population: Evaluable immunogenicity population. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure and "n" signifies participants with valid and determinate assay results for specified serotype at both 1 month after 13vPnC Dose 2 and after 13vPnC Dose 3 blood draws 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 2 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 1 month after 13vPnC Dose 2 and after 13vPnC Dose 3 blood draws.
Outcome measures
| Measure |
13vPnC, 23vPS (All Participants)
n=127 Participants
Participants \>=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
|
13vPnC, 23vPS (Adult Participants)
n=129 Participants
Participants \>=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
|
13vPnC, 23vPS (All Participants)
n=256 Participants
Participants \>=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
|
|---|---|---|---|
|
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric, Adult and All Participants
Serotype 1 (n = 126, 127, 253)
|
1.3 fold rise
Interval 1.13 to 1.61
|
1.3 fold rise
Interval 1.09 to 1.51
|
1.3 fold rise
Interval 1.16 to 1.48
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric, Adult and All Participants
Serotype 7F (n = 125, 127, 252)
|
1.3 fold rise
Interval 1.15 to 1.53
|
1.2 fold rise
Interval 1.03 to 1.4
|
1.3 fold rise
Interval 1.14 to 1.4
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric, Adult and All Participants
Serotype 14 (n = 117, 127, 244)
|
1.1 fold rise
Interval 0.95 to 1.2
|
1.1 fold rise
Interval 0.98 to 1.24
|
1.1 fold rise
Interval 1.0 to 1.18
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric, Adult and All Participants
Serotype 18C (n = 117, 121, 238)
|
1.2 fold rise
Interval 1.1 to 1.32
|
1.3 fold rise
Interval 1.08 to 1.63
|
1.3 fold rise
Interval 1.13 to 1.42
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric, Adult and All Participants
Serotype 3 (n = 127, 129, 256)
|
1.4 fold rise
Interval 1.25 to 1.59
|
1.6 fold rise
Interval 1.45 to 1.83
|
1.5 fold rise
Interval 1.4 to 1.65
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric, Adult and All Participants
Serotype 4 (n = 117, 126, 243)
|
1.3 fold rise
Interval 1.1 to 1.52
|
1.2 fold rise
Interval 1.07 to 1.34
|
1.2 fold rise
Interval 1.13 to 1.37
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric, Adult and All Participants
Serotype 5 (n = 122, 124, 246)
|
1.7 fold rise
Interval 1.36 to 2.06
|
1.4 fold rise
Interval 1.17 to 1.59
|
1.5 fold rise
Interval 1.33 to 1.72
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric, Adult and All Participants
Serotype 6A (n = 125, 124, 249)
|
1.4 fold rise
Interval 1.22 to 1.6
|
1.3 fold rise
Interval 1.15 to 1.55
|
1.4 fold rise
Interval 1.23 to 1.51
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric, Adult and All Participants
Serotype 6B (n = 121, 128, 249)
|
1.3 fold rise
Interval 1.18 to 1.46
|
1.4 fold rise
Interval 1.2 to 1.56
|
1.3 fold rise
Interval 1.23 to 1.46
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric, Adult and All Participants
Serotype 9V (n = 118, 127, 245)
|
1.4 fold rise
Interval 1.16 to 1.72
|
1.4 fold rise
Interval 1.18 to 1.65
|
1.4 fold rise
Interval 1.24 to 1.6
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric, Adult and All Participants
Serotype 19A (n = 125, 127, 252)
|
1.5 fold rise
Interval 1.27 to 1.68
|
1.3 fold rise
Interval 1.18 to 1.52
|
1.4 fold rise
Interval 1.27 to 1.54
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric, Adult and All Participants
Serotype 19F (n = 122, 118, 240)
|
1.6 fold rise
Interval 1.31 to 1.97
|
1.9 fold rise
Interval 1.45 to 2.48
|
1.7 fold rise
Interval 1.48 to 2.06
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric, Adult and All Participants
Serotype 23F (n = 120, 126, 246)
|
1.6 fold rise
Interval 1.31 to 1.9
|
1.6 fold rise
Interval 1.34 to 2.02
|
1.6 fold rise
Interval 1.4 to 1.85
|
SECONDARY outcome
Timeframe: 1 month after 13vPnC Dose 2, 1 month after 13vPnC Dose 3Population: Evaluable immunogenicity population. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure and "n" signifies participants with valid and determinate assay results for specified serotype at both 1 month after 13vPnC Dose 2 and after 13vPnC Dose 3 blood draws 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 2 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 1 month after 13vPnC Dose 2 and after 13vPnC Dose 3 blood draws.
Outcome measures
| Measure |
13vPnC, 23vPS (All Participants)
n=128 Participants
Participants \>=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
|
13vPnC, 23vPS (Adult Participants)
n=131 Participants
Participants \>=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
|
13vPnC, 23vPS (All Participants)
Participants \>=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
|
|---|---|---|---|
|
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric and Adult Participants
Serotype 9V (n = 128, 131)
|
1.03 fold rise
Interval 0.98 to 1.09
|
1.07 fold rise
Interval 1.02 to 1.12
|
—
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric and Adult Participants
Serotype 14 (n = 128, 131)
|
1.09 fold rise
Interval 1.02 to 1.16
|
1.00 fold rise
Interval 0.95 to 1.05
|
—
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric and Adult Participants
Serotype 18C (n = 128, 131)
|
1.01 fold rise
Interval 0.96 to 1.07
|
0.97 fold rise
Interval 0.93 to 1.01
|
—
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric and Adult Participants
Serotype 1 (n = 120, 128)
|
1.07 fold rise
Interval 1.01 to 1.13
|
0.99 fold rise
Interval 0.93 to 1.06
|
—
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric and Adult Participants
Serotype 3 (n = 118, 120)
|
1.01 fold rise
Interval 0.95 to 1.08
|
1.09 fold rise
Interval 1.02 to 1.16
|
—
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric and Adult Participants
Serotype 4 (n = 127, 130)
|
1.10 fold rise
Interval 1.02 to 1.18
|
1.07 fold rise
Interval 1.0 to 1.16
|
—
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric and Adult Participants
Serotype 5 (n = 126, 131)
|
1.07 fold rise
Interval 1.01 to 1.14
|
0.96 fold rise
Interval 0.91 to 1.01
|
—
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric and Adult Participants
Serotype 6A (n = 119, 130)
|
1.04 fold rise
Interval 0.96 to 1.12
|
1.00 fold rise
Interval 0.95 to 1.06
|
—
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric and Adult Participants
Serotype 6B (n = 127, 130)
|
1.04 fold rise
Interval 0.99 to 1.1
|
1.04 fold rise
Interval 0.99 to 1.11
|
—
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric and Adult Participants
Serotype 7F (n = 128, 131)
|
1.19 fold rise
Interval 1.12 to 1.27
|
1.02 fold rise
Interval 0.95 to 1.1
|
—
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric and Adult Participants
Serotype 19A (n = 128, 131)
|
0.99 fold rise
Interval 0.93 to 1.04
|
1.00 fold rise
Interval 0.96 to 1.04
|
—
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric and Adult Participants
Serotype 19F (n = 124, 128)
|
1.05 fold rise
Interval 0.98 to 1.13
|
1.06 fold rise
Interval 0.99 to 1.14
|
—
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric and Adult Participants
Serotype 23F (n = 127, 131)
|
1.03 fold rise
Interval 0.96 to 1.11
|
1.16 fold rise
Interval 1.07 to 1.26
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1Population: Evaluable immunogenicity population. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure and "n" signifies participants with valid and determinate assay results for specified serotype at both the before and 1 month after 13vPnC Dose 1 blood draws 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 both the before and after 13vPnC Dose 1 blood draws. CI for GMC were 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=133 Participants
Participants \>=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
|
13vPnC, 23vPS (Adult Participants)
n=137 Participants
Participants \>=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
|
13vPnC, 23vPS (All Participants)
n=270 Participants
Participants \>=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
|
|---|---|---|---|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
Serotype 6A: Before 13vPnC Dose 1 (n=99,136,235)
|
6.22 mcg/mL
Interval 5.19 to 7.45
|
2.67 mcg/mL
Interval 2.24 to 3.18
|
3.81 mcg/mL
Interval 3.32 to 4.37
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
Serotype 6A: After 13vPnC Dose 1 (n=99,136,235)
|
7.31 mcg/mL
Interval 6.07 to 8.79
|
6.77 mcg/mL
Interval 5.38 to 8.51
|
6.99 mcg/mL
Interval 6.0 to 8.15
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
Serotype 9V: Before 13vPnC Dose 1 (n=129,137,266)
|
2.10 mcg/mL
Interval 1.74 to 2.54
|
1.56 mcg/mL
Interval 1.3 to 1.86
|
1.80 mcg/mL
Interval 1.58 to 2.05
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
Serotype 9V: After 13vPnC Dose 1 (n=129,137,266)
|
4.77 mcg/mL
Interval 4.08 to 5.57
|
5.16 mcg/mL
Interval 4.24 to 6.27
|
4.97 mcg/mL
Interval 4.38 to 5.63
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
Serotype 14: Before 13vPnC Dose 1 (n=113,136,249)
|
0.76 mcg/mL
Interval 0.57 to 1.03
|
2.45 mcg/mL
Interval 1.94 to 3.09
|
1.44 mcg/mL
Interval 1.18 to 1.76
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
Serotype 18C: Before 13vPnC Dose 1 (n=127,134,261)
|
0.66 mcg/mL
Interval 0.52 to 0.85
|
0.85 mcg/mL
Interval 0.69 to 1.04
|
0.75 mcg/mL
Interval 0.64 to 0.88
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
Serotype 18C: After 13vPnC Dose 1 (n=127,134,261)
|
3.92 mcg/mL
Interval 3.14 to 4.91
|
5.55 mcg/mL
Interval 4.51 to 6.84
|
4.69 mcg/mL
Interval 4.02 to 5.46
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
Serotype 19A: Before 13vPnC Dose 1 (n=133,137,270)
|
7.51 mcg/mL
Interval 6.34 to 8.9
|
4.78 mcg/mL
Interval 4.04 to 5.66
|
5.97 mcg/mL
Interval 5.29 to 6.74
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
Serotype 19A: After 13vPnC Dose 1 (n=133,137,270)
|
13.28 mcg/mL
Interval 11.11 to 15.87
|
13.03 mcg/mL
Interval 10.75 to 15.8
|
13.15 mcg/mL
Interval 11.54 to 14.99
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
Serotype 19F: Before 13vPnC Dose 1 (n=93,126,219)
|
1.36 mcg/mL
Interval 1.06 to 1.75
|
1.36 mcg/mL
Interval 1.07 to 1.73
|
1.36 mcg/mL
Interval 1.14 to 1.62
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
Serotype 19F: After 13vPnC Dose 1 (n=93,126,219)
|
4.62 mcg/mL
Interval 3.55 to 6.02
|
4.98 mcg/mL
Interval 3.74 to 6.62
|
4.82 mcg/mL
Interval 3.96 to 5.88
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
Serotype 23F: Before 13vPnC Dose 1 (n=126,137,263)
|
2.29 mcg/mL
Interval 1.83 to 2.86
|
1.61 mcg/mL
Interval 1.31 to 1.96
|
1.90 mcg/mL
Interval 1.64 to 2.21
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
Serotype 23F: After 13vPnC Dose 1 (n=126,137,263)
|
5.65 mcg/mL
Interval 4.66 to 6.86
|
5.30 mcg/mL
Interval 4.16 to 6.75
|
5.47 mcg/mL
Interval 4.68 to 6.39
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
Serotype 6B: Before 13vPnC Dose 1 (n=131,134,265)
|
5.52 mcg/mL
Interval 4.59 to 6.64
|
3.23 mcg/mL
Interval 2.69 to 3.88
|
4.21 mcg/mL
Interval 3.69 to 4.81
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
Serotype 6B: After 13vPnC Dose 1 (n=131,134,265)
|
10.26 mcg/mL
Interval 8.37 to 12.58
|
7.29 mcg/mL
Interval 5.81 to 9.15
|
8.63 mcg/mL
Interval 7.41 to 10.06
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
Serotype 7F: Before 13vPnC Dose 1 (n=111,134,245)
|
0.85 mcg/mL
Interval 0.63 to 1.14
|
1.14 mcg/mL
Interval 0.94 to 1.37
|
1.00 mcg/mL
Interval 0.84 to 1.18
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
Serotype 7F: After 13vPnC Dose 1 (n=111,134,245)
|
4.34 mcg/mL
Interval 3.68 to 5.11
|
5.57 mcg/mL
Interval 4.57 to 6.78
|
4.97 mcg/mL
Interval 4.36 to 5.67
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
Serotype 14: After 13vPnC Dose 1 (n=113,136,249)
|
12.04 mcg/mL
Interval 8.48 to 17.1
|
16.46 mcg/mL
Interval 12.38 to 21.9
|
14.28 mcg/mL
Interval 11.44 to 17.84
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
Serotype 1: Before 13vPnC Dose 1 (n=78,122,200)
|
1.03 mcg/mL
Interval 0.72 to 1.48
|
0.82 mcg/mL
Interval 0.63 to 1.06
|
0.90 mcg/mL
Interval 0.73 to 1.1
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
Serotype 1: After 13vPnC Dose 1 (n=78,122,200)
|
3.78 mcg/mL
Interval 2.97 to 4.8
|
4.00 mcg/mL
Interval 3.19 to 5.01
|
3.91 mcg/mL
Interval 3.32 to 4.61
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
Serotype 3: Before 13vPnC Dose 1 (n=99,127,226)
|
0.83 mcg/mL
Interval 0.62 to 1.11
|
0.47 mcg/mL
Interval 0.37 to 0.58
|
0.60 mcg/mL
Interval 0.5 to 0.72
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
Serotype 3: After 13vPnC Dose 1 (n=99,127,226)
|
1.25 mcg/mL
Interval 0.99 to 1.58
|
0.75 mcg/mL
Interval 0.62 to 0.92
|
0.94 mcg/mL
Interval 0.81 to 1.09
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
Serotype 4: Before 13vPnC Dose 1 (n=95,127,222)
|
0.19 mcg/mL
Interval 0.14 to 0.25
|
0.35 mcg/mL
Interval 0.28 to 0.45
|
0.27 mcg/mL
Interval 0.22 to 0.33
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
Serotype 4: After 13vPnC Dose 1 (n=95,127,222)
|
2.62 mcg/mL
Interval 1.97 to 3.5
|
2.91 mcg/mL
Interval 2.26 to 3.75
|
2.79 mcg/mL
Interval 2.31 to 3.36
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
Serotype 5: Before 13vPnC Dose 1 (n=122,137,259)
|
4.18 mcg/mL
Interval 3.42 to 5.12
|
3.38 mcg/mL
Interval 2.84 to 4.02
|
3.74 mcg/mL
Interval 3.28 to 4.27
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
Serotype 5: After 13vPnC Dose 1 (n=122,137,259)
|
4.81 mcg/mL
Interval 3.98 to 5.8
|
5.53 mcg/mL
Interval 4.63 to 6.61
|
5.18 mcg/mL
Interval 4.55 to 5.89
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1Population: Evaluable immunogenicity population. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure and "n" signifies participants with valid and determinate assay results for specified serotype at both the before and 1 month after 13vPnC Dose 1 blood draws 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 1 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 and after 13vPnC Dose 1 blood draws.
Outcome measures
| Measure |
13vPnC, 23vPS (All Participants)
n=133 Participants
Participants \>=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
|
13vPnC, 23vPS (Adult Participants)
n=137 Participants
Participants \>=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
|
13vPnC, 23vPS (All Participants)
n=270 Participants
Participants \>=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
|
|---|---|---|---|
|
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
Serotype 3 (n = 99, 127, 226)
|
1.51 fold rise
Interval 1.27 to 1.79
|
1.62 fold rise
Interval 1.43 to 1.83
|
1.57 fold rise
Interval 1.42 to 1.74
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
Serotype 4 (n = 95, 127, 222)
|
14.02 fold rise
Interval 10.55 to 18.62
|
8.29 fold rise
Interval 6.55 to 10.49
|
10.38 fold rise
Interval 8.64 to 12.47
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
Serotype 5 (n = 122, 137, 259)
|
1.15 fold rise
Interval 1.06 to 1.25
|
1.64 fold rise
Interval 1.44 to 1.85
|
1.38 fold rise
Interval 1.28 to 1.5
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
Serotype 6A (n = 99, 136, 235)
|
1.18 fold rise
Interval 1.02 to 1.35
|
2.54 fold rise
Interval 2.09 to 3.07
|
1.83 fold rise
Interval 1.6 to 2.1
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
Serotype 6B (n = 131, 134, 265)
|
1.86 fold rise
Interval 1.55 to 2.22
|
2.26 fold rise
Interval 1.87 to 2.72
|
2.05 fold rise
Interval 1.8 to 2.33
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
Serotype 7F (n = 111, 134, 245)
|
5.11 fold rise
Interval 3.92 to 6.65
|
4.90 fold rise
Interval 3.99 to 6.03
|
4.99 fold rise
Interval 4.24 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 1 in Pediatric, Adult and All Participants
Serotype 9V (n = 129, 137, 266)
|
2.27 fold rise
Interval 1.97 to 2.61
|
3.32 fold rise
Interval 2.76 to 3.99
|
2.76 fold rise
Interval 2.45 to 3.1
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
Serotype 14 (n = 113, 136, 249)
|
15.79 fold rise
Interval 11.84 to 21.05
|
6.73 fold rise
Interval 5.17 to 8.76
|
9.91 fold rise
Interval 8.11 to 12.11
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
Serotype 18C (n = 127, 134, 261)
|
5.92 fold rise
Interval 4.64 to 7.55
|
6.55 fold rise
Interval 5.23 to 8.2
|
6.23 fold rise
Interval 5.29 to 7.35
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
Serotype 19A (n = 133, 137, 270)
|
1.77 fold rise
Interval 1.55 to 2.02
|
2.73 fold rise
Interval 2.31 to 3.21
|
2.20 fold rise
Interval 1.98 to 2.45
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
Serotype 19F (n = 93, 126, 219)
|
3.39 fold rise
Interval 2.71 to 4.25
|
3.66 fold rise
Interval 2.96 to 4.52
|
3.54 fold rise
Interval 3.04 to 4.13
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
Serotype 23F (n = 126, 137, 263)
|
2.47 fold rise
Interval 2.02 to 3.02
|
3.30 fold rise
Interval 2.71 to 4.03
|
2.87 fold rise
Interval 2.49 to 3.31
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
Serotype 1 (n = 78, 122, 200)
|
3.67 fold rise
Interval 2.7 to 4.99
|
4.88 fold rise
Interval 3.87 to 6.15
|
4.37 fold rise
Interval 3.63 to 5.25
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1Population: Evaluable immunogenicity population. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure and "n" signifies participants with valid and determinate assay results for specified serotype at both the before and 1 month after 13vPnC Dose 1 blood draws for each treatment arm, respectively.
Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of pediatric, adult and all participants using a microcolony OPA (mcOPA) assay. GMT (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data for both the before and after 13vPnC Dose 1 blood draws. CI for GMT were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
Outcome measures
| Measure |
13vPnC, 23vPS (All Participants)
n=129 Participants
Participants \>=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
|
13vPnC, 23vPS (Adult Participants)
n=128 Participants
Participants \>=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
|
13vPnC, 23vPS (All Participants)
n=257 Participants
Participants \>=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
|
|---|---|---|---|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
Serotype 1: Before 13vPnC Dose 1 (n=129,127,256)
|
5 titers
Interval 4.3 to 5.8
|
5 titers
Interval 4.3 to 5.2
|
5 titers
Interval 4.4 to 5.3
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
Serotype 3: Before 13vPnC Dose 1 (n=126,128,254)
|
8 titers
Interval 6.6 to 10.8
|
5 titers
Interval 4.5 to 5.8
|
7 titers
Interval 5.7 to 7.5
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
Serotype 4: After 13vPnC Dose 1 (n=108,119,227)
|
2247 titers
Interval 1611.9 to 3131.4
|
1372 titers
Interval 958.8 to 1963.7
|
1735 titers
Interval 1356.9 to 2218.3
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
Serotype 5: After 13vPnC Dose 1 (n=125,122,247)
|
79 titers
Interval 52.5 to 118.0
|
123 titers
Interval 81.8 to 186.3
|
98 titers
Interval 73.7 to 131.1
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
Serotype 6A: Before 13vPnC Dose 1 (n=99,98,197)
|
157 titers
Interval 84.4 to 292.5
|
61 titers
Interval 35.1 to 106.8
|
98 titers
Interval 64.6 to 149.4
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
Serotype 6A: After 13vPnC Dose 1 (n=99,98,197)
|
3480 titers
Interval 2460.1 to 4921.8
|
1543 titers
Interval 984.4 to 2418.5
|
2322 titers
Interval 1743.1 to 3092.9
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
Serotype 6B: Before 13vPnC Dose 1 (n=101,120,221)
|
279 titers
Interval 155.5 to 501.1
|
231 titers
Interval 143.4 to 372.5
|
252 titers
Interval 174.1 to 364.6
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
Serotype 6B: After 13vPnC Dose 1 (n=101,120,221)
|
3852 titers
Interval 2888.3 to 5137.8
|
2099 titers
Interval 1455.6 to 3028.2
|
2771 titers
Interval 2179.2 to 3522.5
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
Serotype 7F: Before 13vPnC Dose 1 (n=110,113,223)
|
416 titers
Interval 253.5 to 682.9
|
38 titers
Interval 22.9 to 64.6
|
124 titers
Interval 84.3 to 183.8
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
Serotype 7F: After 13vPnC Dose 1 (n=110,113,223)
|
3775 titers
Interval 3019.4 to 4720.1
|
2005 titers
Interval 1443.9 to 2783.1
|
2739 titers
Interval 2237.5 to 3353.5
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
Serotype 9V: Before 13vPnC Dose 1 (n=109,117,226)
|
152 titers
Interval 87.2 to 266.2
|
69 titers
Interval 40.7 to 117.2
|
101 titers
Interval 68.8 to 148.6
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
Serotype 9V: After 13vPnC Dose 1 (n=109,117,226)
|
2533 titers
Interval 1822.7 to 3520.3
|
1231 titers
Interval 836.1 to 1812.2
|
1743 titers
Interval 1347.0 to 2256.4
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
Serotype 14: Before 13vPnC Dose 1 (n=107,126,233)
|
328 titers
Interval 201.4 to 535.5
|
123 titers
Interval 79.6 to 191.4
|
193 titers
Interval 139.0 to 269.2
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
Serotype 14: After 13vPnC Dose 1 (n=107,126,233)
|
3571 titers
Interval 2772.2 to 4600.1
|
1277 titers
Interval 944.9 to 1725.8
|
2048 titers
Interval 1660.8 to 2524.9
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
Serotype 18C: Before 13vPnC Dose 1 (n=95,120,215)
|
42 titers
Interval 21.9 to 79.0
|
25 titers
Interval 15.5 to 39.6
|
31 titers
Interval 21.2 to 45.8
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
Serotype 18C: After 13vPnC Dose 1 (n=95,120,215)
|
2821 titers
Interval 1891.1 to 4208.9
|
1031 titers
Interval 671.3 to 1584.6
|
1609 titers
Interval 1188.2 to 2178.5
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
Serotype 19A: Before 13vPnC Dose 1 (n=129,128,257)
|
28 titers
Interval 19.1 to 40.8
|
23 titers
Interval 16.7 to 32.7
|
26 titers
Interval 19.9 to 32.9
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
Serotype 19A: After 13vPnC Dose 1 (n=129,128,257)
|
506 titers
Interval 381.9 to 671.7
|
390 titers
Interval 275.2 to 552.8
|
445 titers
Interval 355.7 to 555.9
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
Serotype 19F: Before 13vPnC Dose 1 (n=123,123,246)
|
11 titers
Interval 7.6 to 15.5
|
14 titers
Interval 9.5 to 20.1
|
12 titers
Interval 9.5 to 15.8
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
Serotype 19F: After 13vPnC Dose 1 (n=123,123,246)
|
425 titers
Interval 285.3 to 632.5
|
214 titers
Interval 130.4 to 352.3
|
302 titers
Interval 219.3 to 415.2
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
Serotype 23F: Before 13vPnC Dose 1 (n=118,125,243)
|
14 titers
Interval 9.3 to 22.0
|
7 titers
Interval 5.3 to 9.0
|
10 titers
Interval 7.6 to 12.7
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
Serotype 23F: After 13vPnC Dose 1 (n=118,125,243)
|
587 titers
Interval 379.3 to 907.7
|
140 titers
Interval 86.6 to 227.6
|
281 titers
Interval 200.8 to 393.7
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
Serotype 1: After 13vPnC Dose 1 (n=129,127,256)
|
49 titers
Interval 35.3 to 68.1
|
57 titers
Interval 41.6 to 79.3
|
53 titers
Interval 42.2 to 66.7
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
Serotype 3: After 13vPnC Dose 1 (n=126,128,254)
|
41 titers
Interval 31.7 to 52.6
|
21 titers
Interval 16.3 to 27.1
|
29 titers
Interval 24.3 to 35.1
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
Serotype 4: Before 13vPnC Dose 1 (n=108,119,227)
|
25 titers
Interval 15.2 to 41.7
|
27 titers
Interval 17.0 to 42.1
|
26 titers
Interval 18.6 to 36.3
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
Serotype 5: Before 13vPnC Dose 1 (n=125,122,247)
|
5 titers
Interval 4.5 to 6.7
|
6 titers
Interval 4.8 to 6.8
|
6 titers
Interval 4.9 to 6.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1Population: Evaluable immunogenicity population. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure and "n" signifies participants with valid and determinate assay results for specified serotype at both the before and 1 month after 13vPnC Dose 1 blood draws 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 1 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 and after 13vPnC Dose 1 blood draws.
Outcome measures
| Measure |
13vPnC, 23vPS (All Participants)
n=129 Participants
Participants \>=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
|
13vPnC, 23vPS (Adult Participants)
n=128 Participants
Participants \>=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
|
13vPnC, 23vPS (All Participants)
n=257 Participants
Participants \>=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
|
|---|---|---|---|
|
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
Serotype 1 (n = 129, 127, 256)
|
9.8 fold rise
Interval 6.97 to 13.81
|
12.2 fold rise
Interval 8.84 to 16.84
|
10.9 fold rise
Interval 8.65 to 13.81
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
Serotype 3 (n = 126, 128, 254)
|
4.8 fold rise
Interval 3.72 to 6.3
|
4.1 fold rise
Interval 3.22 to 5.3
|
4.5 fold rise
Interval 3.73 to 5.35
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
Serotype 4 (n = 108, 119, 227)
|
89.4 fold rise
Interval 51.43 to 155.31
|
51.3 fold rise
Interval 31.16 to 84.59
|
66.8 fold rise
Interval 46.17 to 96.75
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
Serotype 5 (n = 125, 122, 247)
|
14.4 fold rise
Interval 9.56 to 21.67
|
21.7 fold rise
Interval 14.55 to 32.32
|
17.6 fold rise
Interval 13.25 to 23.44
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
Serotype 6A (n = 99, 98, 197)
|
22.2 fold rise
Interval 12.61 to 38.9
|
25.2 fold rise
Interval 14.51 to 43.83
|
23.6 fold rise
Interval 15.98 to 34.94
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
Serotype 6B (n = 101, 120, 221)
|
13.8 fold rise
Interval 8.12 to 23.45
|
9.1 fold rise
Interval 5.91 to 13.95
|
11.0 fold rise
Interval 7.87 to 15.37
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
Serotype 7F (n = 110, 113, 223)
|
9.1 fold rise
Interval 5.79 to 14.23
|
52.2 fold rise
Interval 31.42 to 86.57
|
22.0 fold rise
Interval 15.42 to 31.42
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
Serotype 9V (n = 109, 117, 226)
|
16.6 fold rise
Interval 9.71 to 28.47
|
17.8 fold rise
Interval 10.53 to 30.18
|
17.2 fold rise
Interval 11.87 to 25.04
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
Serotype 14 (n = 107, 126, 233)
|
10.9 fold rise
Interval 6.79 to 17.41
|
10.3 fold rise
Interval 6.82 to 15.7
|
10.6 fold rise
Interval 7.76 to 14.44
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
Serotype 18C (n = 95, 120, 215)
|
67.9 fold rise
Interval 35.25 to 130.73
|
41.6 fold rise
Interval 24.59 to 70.26
|
51.6 fold rise
Interval 34.27 to 77.78
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
Serotype 19A (n = 129, 128, 257)
|
18.1 fold rise
Interval 12.52 to 26.25
|
16.7 fold rise
Interval 11.78 to 23.61
|
17.4 fold rise
Interval 13.51 to 22.38
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
Serotype 19F (n = 123, 123, 246)
|
39.0 fold rise
Interval 24.56 to 62.05
|
15.5 fold rise
Interval 9.77 to 24.65
|
24.6 fold rise
Interval 17.69 to 34.25
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
Serotype 23F (n = 118, 125, 243)
|
41.1 fold rise
Interval 24.94 to 67.81
|
20.2 fold rise
Interval 12.78 to 32.05
|
28.6 fold rise
Interval 20.34 to 40.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 month after 13vPnC Dose 3, 1 month after 23vPS DosePopulation: Evaluable immunogenicity population. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure and "n" signifies participants with valid and determinate assay results for specified serotype at both 1 month after 13vPnC Dose 3 and after 23vPS Dose blood draws 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 both after 13vPnC Dose 3 and after 23vPS Dose blood draws. CI for GMC were 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=133 Participants
Participants \>=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
|
13vPnC, 23vPS (Adult Participants)
n=130 Participants
Participants \>=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
|
13vPnC, 23vPS (All Participants)
n=263 Participants
Participants \>=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
|
|---|---|---|---|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
Serotype 1: After 13vPnC Dose 3 (n=128,127,255)
|
4.08 mcg/mL
Interval 3.53 to 4.73
|
3.94 mcg/mL
Interval 3.22 to 4.82
|
4.01 mcg/mL
Interval 3.54 to 4.54
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
Serotype 1: After 23vPS Dose (n=128,127,255)
|
4.42 mcg/mL
Interval 3.8 to 5.14
|
4.02 mcg/mL
Interval 3.32 to 4.85
|
4.21 mcg/mL
Interval 3.74 to 4.75
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
Serotype 3: After 13vPnC Dose 3 (n=124,118,242)
|
1.49 mcg/mL
Interval 1.27 to 1.75
|
1.04 mcg/mL
Interval 0.87 to 1.26
|
1.25 mcg/mL
Interval 1.11 to 1.42
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
Serotype 3: After 23vPS Dose (n=124,118,242)
|
1.65 mcg/mL
Interval 1.42 to 1.92
|
0.98 mcg/mL
Interval 0.82 to 1.17
|
1.28 mcg/mL
Interval 1.14 to 1.44
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
Serotype 4: After 13vPnC Dose 3 (n=133,128,261)
|
3.29 mcg/mL
Interval 2.79 to 3.87
|
3.19 mcg/mL
Interval 2.59 to 3.93
|
3.24 mcg/mL
Interval 2.84 to 3.7
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
Serotype 4: After 23vPS Dose (n=133,128,261)
|
3.28 mcg/mL
Interval 2.77 to 3.88
|
3.01 mcg/mL
Interval 2.44 to 3.72
|
3.15 mcg/mL
Interval 2.75 to 3.59
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
Serotype 5: After 13vPnC Dose 3 (n=132,130,262)
|
4.73 mcg/mL
Interval 4.02 to 5.57
|
5.54 mcg/mL
Interval 4.64 to 6.63
|
5.12 mcg/mL
Interval 4.54 to 5.78
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
Serotype 5: After 23vPS Dose (n=132,130,262)
|
5.08 mcg/mL
Interval 4.33 to 5.95
|
6.20 mcg/mL
Interval 5.23 to 7.35
|
5.61 mcg/mL
Interval 4.99 to 6.3
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
Serotype 6A: After 13vPnC Dose 3 (n=122,129,251)
|
8.20 mcg/mL
Interval 6.99 to 9.61
|
7.07 mcg/mL
Interval 5.75 to 8.69
|
7.60 mcg/mL
Interval 6.67 to 8.66
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
Serotype 6A: After 23vPS Dose (n=122,129,251)
|
7.98 mcg/mL
Interval 6.85 to 9.31
|
6.71 mcg/mL
Interval 5.51 to 8.17
|
7.30 mcg/mL
Interval 6.44 to 8.27
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
Serotype 6B: After 13vPnC Dose 3 (n=133,129,262)
|
12.25 mcg/mL
Interval 10.31 to 14.55
|
8.29 mcg/mL
Interval 6.78 to 10.13
|
10.10 mcg/mL
Interval 8.84 to 11.55
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
Serotype 6B: After 23vPS Dose (n=133,129,262)
|
11.10 mcg/mL
Interval 9.39 to 13.13
|
8.25 mcg/mL
Interval 6.8 to 10.01
|
9.59 mcg/mL
Interval 8.44 to 10.9
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
Serotype 7F: After 13vPnC Dose 3 (n=133,130,263)
|
5.05 mcg/mL
Interval 4.39 to 5.81
|
5.88 mcg/mL
Interval 4.93 to 7.02
|
5.44 mcg/mL
Interval 4.87 to 6.09
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
Serotype 7F: After 23vPS Dose (n=133,130,263)
|
5.15 mcg/mL
Interval 4.5 to 5.9
|
5.93 mcg/mL
Interval 5.02 to 7.0
|
5.52 mcg/mL
Interval 4.96 to 6.14
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
Serotype 9V: After 13vPnC Dose 3 (n=133,130,263)
|
5.02 mcg/mL
Interval 4.4 to 5.72
|
5.49 mcg/mL
Interval 4.59 to 6.57
|
5.25 mcg/mL
Interval 4.7 to 5.86
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
Serotype 9V: After 23vPS Dose (n=133,130,263)
|
5.27 mcg/mL
Interval 4.62 to 6.0
|
5.83 mcg/mL
Interval 4.88 to 6.96
|
5.54 mcg/mL
Interval 4.96 to 6.18
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
Serotype 14: After 13vPnC Dose 3 (n=133,130,263)
|
13.18 mcg/mL
Interval 10.19 to 17.05
|
15.35 mcg/mL
Interval 11.97 to 19.69
|
14.21 mcg/mL
Interval 11.89 to 16.98
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
Serotype 14: After 23vPS Dose (n=133,130,263)
|
12.98 mcg/mL
Interval 10.1 to 16.67
|
16.24 mcg/mL
Interval 12.82 to 20.57
|
14.50 mcg/mL
Interval 12.21 to 17.21
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
Serotype 18C: After 13vPnC Dose 3 (n=132,130,262)
|
3.84 mcg/mL
Interval 3.21 to 4.59
|
5.17 mcg/mL
Interval 4.25 to 6.28
|
4.45 mcg/mL
Interval 3.9 to 5.08
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
Serotype 18C: After 23vPS Dose (n=132,130,262)
|
3.54 mcg/mL
Interval 2.98 to 4.2
|
4.80 mcg/mL
Interval 3.98 to 5.79
|
4.12 mcg/mL
Interval 3.62 to 4.68
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
Serotype 19A: After 13vPnC Dose 3 (n=133,130,263)
|
14.16 mcg/mL
Interval 12.21 to 16.41
|
13.21 mcg/mL
Interval 11.13 to 15.68
|
13.68 mcg/mL
Interval 12.22 to 15.31
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
Serotype 19A: After 23vPS Dose (n=133,130,263)
|
13.16 mcg/mL
Interval 11.31 to 15.33
|
13.28 mcg/mL
Interval 11.24 to 15.69
|
13.22 mcg/mL
Interval 11.82 to 14.79
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
Serotype 19F: After 13vPnC Dose 3 (n=130,127,257)
|
6.15 mcg/mL
Interval 5.09 to 7.45
|
5.67 mcg/mL
Interval 4.47 to 7.19
|
5.91 mcg/mL
Interval 5.08 to 6.87
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
Serotype 19F: After 23vPS Dose (n=130,127,257)
|
6.78 mcg/mL
Interval 5.65 to 8.14
|
5.84 mcg/mL
Interval 4.62 to 7.39
|
6.30 mcg/mL
Interval 5.44 to 7.3
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
Serotype 23F: After 13vPnC Dose 3 (n=132,129,261)
|
6.69 mcg/mL
Interval 5.6 to 7.98
|
7.30 mcg/mL
Interval 5.87 to 9.09
|
6.98 mcg/mL
Interval 6.07 to 8.03
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
Serotype 23F: After 23vPS Dose (n=132,129,261)
|
5.99 mcg/mL
Interval 5.05 to 7.11
|
7.03 mcg/mL
Interval 5.69 to 8.7
|
6.49 mcg/mL
Interval 5.66 to 7.43
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 month after 13vPnC Dose 3, 1 month after 23vPS DosePopulation: Evaluable immunogenicity population. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure and "n" signifies participants with valid and determinate assay results for specified serotype at both 1 month after 13vPnC Dose 3 and after 23vPS Dose blood draws 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 23vPS Dose 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 1 month after 13vPnC Dose 3 and 1 month after 23vPS Dose blood draws.
Outcome measures
| Measure |
13vPnC, 23vPS (All Participants)
n=133 Participants
Participants \>=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
|
13vPnC, 23vPS (Adult Participants)
n=130 Participants
Participants \>=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
|
13vPnC, 23vPS (All Participants)
n=263 Participants
Participants \>=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
|
|---|---|---|---|
|
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
Serotype 1 (n = 128, 127, 255)
|
1.08 fold rise
Interval 1.01 to 1.16
|
1.02 fold rise
Interval 0.96 to 1.08
|
1.05 fold rise
Interval 1.0 to 1.1
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
Serotype 4 (n = 133, 128, 261)
|
1.00 fold rise
Interval 0.94 to 1.05
|
0.94 fold rise
Interval 0.9 to 0.99
|
0.97 fold rise
Interval 0.94 to 1.01
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
Serotype 3 (n = 124, 118, 242)
|
1.11 fold rise
Interval 1.03 to 1.2
|
0.94 fold rise
Interval 0.88 to 1.0
|
1.02 fold rise
Interval 0.97 to 1.08
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
Serotype 5 (n = 132, 130, 262)
|
1.07 fold rise
Interval 1.02 to 1.13
|
1.12 fold rise
Interval 1.05 to 1.19
|
1.09 fold rise
Interval 1.05 to 1.14
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
Serotype 6A (n = 122, 129, 251)
|
0.97 fold rise
Interval 0.92 to 1.04
|
0.95 fold rise
Interval 0.91 to 0.99
|
0.96 fold rise
Interval 0.93 to 1.0
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
Serotype 6B (n = 133, 129, 262)
|
0.91 fold rise
Interval 0.87 to 0.95
|
1.00 fold rise
Interval 0.96 to 1.04
|
0.95 fold rise
Interval 0.92 to 0.98
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
Serotype 7F (n = 133, 130, 263)
|
1.02 fold rise
Interval 0.97 to 1.07
|
1.01 fold rise
Interval 0.95 to 1.06
|
1.01 fold rise
Interval 0.98 to 1.05
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
Serotype 9V (n = 133, 130, 263)
|
1.05 fold rise
Interval 1.0 to 1.1
|
1.06 fold rise
Interval 1.01 to 1.11
|
1.06 fold rise
Interval 1.02 to 1.09
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
Serotype 14 (n = 133, 130, 263)
|
0.98 fold rise
Interval 0.91 to 1.06
|
1.06 fold rise
Interval 0.99 to 1.13
|
1.02 fold rise
Interval 0.97 to 1.07
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
Serotype 18C (n = 132, 130, 262)
|
0.92 fold rise
Interval 0.88 to 0.96
|
0.93 fold rise
Interval 0.89 to 0.97
|
0.92 fold rise
Interval 0.9 to 0.95
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
Serotype 19A (n = 133, 130, 263)
|
0.93 fold rise
Interval 0.89 to 0.97
|
1.01 fold rise
Interval 0.96 to 1.05
|
0.97 fold rise
Interval 0.94 to 1.0
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
Serotype 19F (n = 130, 127, 257)
|
1.10 fold rise
Interval 1.04 to 1.17
|
1.03 fold rise
Interval 0.97 to 1.09
|
1.07 fold rise
Interval 1.02 to 1.11
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
Serotype 23F (n = 132, 129, 261)
|
0.90 fold rise
Interval 0.86 to 0.94
|
0.96 fold rise
Interval 0.91 to 1.02
|
0.93 fold rise
Interval 0.89 to 0.96
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 month after 13vPnC Dose 3, 1 month after 23vPS DosePopulation: Evaluable immunogenicity population. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure and "n" signifies participants with valid and determinate assay results for specified serotype at both 1 month after 13vPnC Dose 3 and after 23vPS Dose blood draws for each treatment arm, respectively.
Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of pediatric, adult and all participants using a mcOPA assay. GMT (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data for both after 13vPnC Dose 3 and after 23vPS Dose blood draws. CI for GMT were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
Outcome measures
| Measure |
13vPnC, 23vPS (All Participants)
n=132 Participants
Participants \>=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
|
13vPnC, 23vPS (Adult Participants)
n=128 Participants
Participants \>=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
|
13vPnC, 23vPS (All Participants)
n=260 Participants
Participants \>=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
|
|---|---|---|---|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
Serotype 1: After 13vPnC Dose 3 (n=131,125,256)
|
70 titers
Interval 53.4 to 93.0
|
67 titers
Interval 50.2 to 90.6
|
69 titers
Interval 56.4 to 84.3
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
Serotype 1: After 23vPS Dose (n=131,125,256)
|
100 titers
Interval 76.6 to 130.3
|
66 titers
Interval 49.0 to 90.2
|
82 titers
Interval 66.9 to 100.2
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
Serotype 3: After 13vPnC Dose 3 (n=132,128,260)
|
114 titers
Interval 94.6 to 136.7
|
78 titers
Interval 61.3 to 98.7
|
94 titers
Interval 81.1 to 109.7
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
Serotype 3: After 23vPS Dose (n=132,128,260)
|
148 titers
Interval 123.9 to 177.3
|
103 titers
Interval 81.6 to 130.9
|
124 titers
Interval 107.0 to 144.0
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
Serotype 4: After 13vPnC Dose 3 (n=127,126,253)
|
3213 titers
Interval 2698.5 to 3826.6
|
1888 titers
Interval 1427.3 to 2498.1
|
2466 titers
Interval 2087.0 to 2913.5
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
Serotype 4: After 23vPS Dose (n=127,126,253)
|
3553 titers
Interval 2984.9 to 4229.7
|
1831 titers
Interval 1366.0 to 2453.7
|
2554 titers
Interval 2146.3 to 3038.7
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
Serotype 5: After 13vPnC Dose 3 (n=129,124,253)
|
270 titers
Interval 197.0 to 370.1
|
143 titers
Interval 97.5 to 209.6
|
198 titers
Interval 154.2 to 253.5
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
Serotype 5: After 23vPS Dose (n=129,124,253)
|
378 titers
Interval 276.5 to 516.9
|
186 titers
Interval 130.9 to 264.4
|
267 titers
Interval 210.6 to 338.6
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
Serotype 6A: After 13vPnC Dose 3 (n=132,127,259)
|
8011 titers
Interval 6580.0 to 9752.1
|
2956 titers
Interval 2240.1 to 3900.3
|
4913 titers
Interval 4109.7 to 5873.6
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
Serotype 6A: After 23vPS Dose (n=132,127,259)
|
7236 titers
Interval 5936.2 to 8819.4
|
2707 titers
Interval 2060.8 to 3556.3
|
4468 titers
Interval 3743.3 to 5333.1
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
Serotype 6B: After 13vPnC Dose 3 (n=130,126,256)
|
7102 titers
Interval 5853.9 to 8615.8
|
3666 titers
Interval 2720.7 to 4940.5
|
5129 titers
Interval 4283.9 to 6141.0
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
Serotype 6B: After 23vPS Dose (n=130,126,256)
|
6652 titers
Interval 5460.8 to 8102.8
|
3324 titers
Interval 2496.6 to 4426.2
|
4728 titers
Interval 3961.1 to 5643.2
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
Serotype 7F: After 13vPnC Dose 3 (n=131,125,256)
|
4640 titers
Interval 3915.9 to 5497.9
|
2821 titers
Interval 2283.2 to 3484.4
|
3639 titers
Interval 3171.6 to 4174.8
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
Serotype 7F: After 23vPS Dose (n=131,125,256)
|
5260 titers
Interval 4470.4 to 6189.9
|
3027 titers
Interval 2455.7 to 3731.3
|
4016 titers
Interval 3508.3 to 4597.9
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
Serotype 9V: After 13vPnC Dose 3 (n=127,125,252)
|
4501 titers
Interval 3606.4 to 5618.0
|
1980 titers
Interval 1394.6 to 2811.7
|
2995 titers
Interval 2424.2 to 3700.8
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
Serotype 9V: After 23vPS Dose (n=127,125,252)
|
5114 titers
Interval 4090.6 to 6393.0
|
2037 titers
Interval 1452.6 to 2857.6
|
3240 titers
Interval 2629.5 to 3991.2
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
Serotype 14: After 13vPnC Dose 3 (n=127,126,253)
|
4023 titers
Interval 3317.5 to 4879.5
|
1431 titers
Interval 1115.7 to 1836.1
|
2405 titers
Interval 2030.8 to 2847.1
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
Serotype 14: After 23vPS Dose (n=127,126,253)
|
4718 titers
Interval 3861.6 to 5764.9
|
1620 titers
Interval 1284.5 to 2043.0
|
2771 titers
Interval 2346.9 to 3270.7
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
Serotype 18C: After 13vPnC Dose 3 (n=129,121,250)
|
5455 titers
Interval 4401.5 to 6761.4
|
1667 titers
Interval 1172.5 to 2370.8
|
3074 titers
Interval 2479.2 to 3810.5
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
Serotype 18C: After 23vPS Dose (n=129,121,250)
|
6468 titers
Interval 5341.1 to 7832.2
|
1835 titers
Interval 1328.1 to 2535.5
|
3515 titers
Interval 2878.5 to 4292.8
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
Serotype 19A: After 13vPnC Dose 3 (n=131,125,256)
|
1021 titers
Interval 837.5 to 1245.6
|
603 titers
Interval 456.7 to 796.3
|
790 titers
Interval 665.2 to 937.4
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
Serotype 19F: After 13vPnC Dose 3 (n=126,117,243)
|
1166 titers
Interval 884.3 to 1537.7
|
564 titers
Interval 375.0 to 848.1
|
822 titers
Interval 642.8 to 1051.0
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
Serotype 19F: After 23vPS Dose (n=126,117,243)
|
1696 titers
Interval 1296.5 to 2217.5
|
790 titers
Interval 547.5 to 1139.7
|
1174 titers
Interval 934.2 to 1474.8
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
Serotype 23F: After 23vPS Dose (n=128,126,254)
|
2595 titers
Interval 2143.3 to 3141.5
|
580 titers
Interval 386.1 to 871.8
|
1234 titers
Interval 970.1 to 1570.3
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
Serotype 19A: After 23vPS Dose (n=131,125,256)
|
1244 titers
Interval 1012.1 to 1529.5
|
691 titers
Interval 531.0 to 898.6
|
933 titers
Interval 788.2 to 1105.5
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
Serotype 23F: After 13vPnC Dose 3 (n=128,126,254)
|
2346 titers
Interval 1883.3 to 2922.6
|
650 titers
Interval 435.3 to 969.9
|
1241 titers
Interval 976.6 to 1576.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 month after 13vPnC Dose 3, 1 month after 23vPS DosePopulation: Evaluable immunogenicity population. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure and "n" signifies participants with valid and determinate assay results for specified serotype at both 1 month after 13vPnC Dose 3 and after 23vPS Dose blood draws 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 23vPS Dose 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 1 month after 13vPnC Dose 3 and 1 month after 23vPS Dose blood draws.
Outcome measures
| Measure |
13vPnC, 23vPS (All Participants)
n=132 Participants
Participants \>=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
|
13vPnC, 23vPS (Adult Participants)
n=128 Participants
Participants \>=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
|
13vPnC, 23vPS (All Participants)
n=260 Participants
Participants \>=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
|
|---|---|---|---|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
Serotype 3 (n = 132, 128, 260)
|
1.3 fold rise
Interval 1.15 to 1.48
|
1.3 fold rise
Interval 1.17 to 1.51
|
1.3 fold rise
Interval 1.2 to 1.44
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
Serotype 6B (n = 130, 126, 256)
|
0.9 fold rise
Interval 0.87 to 1.01
|
0.9 fold rise
Interval 0.79 to 1.04
|
0.9 fold rise
Interval 0.86 to 0.99
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
Serotype 9V (n = 127, 125, 252)
|
1.1 fold rise
Interval 1.05 to 1.23
|
1.0 fold rise
Interval 0.84 to 1.27
|
1.1 fold rise
Interval 0.97 to 1.21
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
Serotype 14 (n = 127, 126, 253)
|
1.2 fold rise
Interval 1.07 to 1.28
|
1.1 fold rise
Interval 1.03 to 1.24
|
1.2 fold rise
Interval 1.08 to 1.23
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
Serotype 18C (n = 129, 121, 250)
|
1.2 fold rise
Interval 1.04 to 1.35
|
1.1 fold rise
Interval 0.92 to 1.31
|
1.1 fold rise
Interval 1.03 to 1.27
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
Serotype 1 (n = 131, 125, 256)
|
1.4 fold rise
Interval 1.23 to 1.63
|
1.0 fold rise
Interval 0.86 to 1.13
|
1.2 fold rise
Interval 1.08 to 1.31
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
Serotype 4 (n = 127, 126, 253)
|
1.1 fold rise
Interval 1.04 to 1.18
|
1.0 fold rise
Interval 0.87 to 1.09
|
1.0 fold rise
Interval 0.97 to 1.1
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
Serotype 5 (n = 129, 124, 253)
|
1.4 fold rise
Interval 1.15 to 1.71
|
1.3 fold rise
Interval 1.13 to 1.5
|
1.4 fold rise
Interval 1.2 to 1.53
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
Serotype 6A (n = 132, 127, 259)
|
0.9 fold rise
Interval 0.85 to 0.96
|
0.9 fold rise
Interval 0.86 to 0.97
|
0.9 fold rise
Interval 0.87 to 0.95
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
Serotype 7F (n = 131, 125, 256)
|
1.1 fold rise
Interval 1.06 to 1.21
|
1.1 fold rise
Interval 0.93 to 1.23
|
1.1 fold rise
Interval 1.02 to 1.19
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
Serotype 19A (n = 131, 125, 256)
|
1.2 fold rise
Interval 1.11 to 1.34
|
1.1 fold rise
Interval 1.03 to 1.27
|
1.2 fold rise
Interval 1.1 to 1.27
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
Serotype 19F (n = 126, 117, 243)
|
1.5 fold rise
Interval 1.25 to 1.69
|
1.4 fold rise
Interval 1.14 to 1.72
|
1.4 fold rise
Interval 1.26 to 1.62
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
Serotype 23F (n = 128, 126, 254)
|
1.1 fold rise
Interval 0.96 to 1.28
|
0.9 fold rise
Interval 0.81 to 0.98
|
1.0 fold rise
Interval 0.91 to 1.09
|
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 6 to \<12 years and 2.5 to 5.0 cm for participants aged greater than (\>) 12 years); Moderate (2.5 to 7.0 cm for participants aged 6 to \<12 years and 5.1 to 10.0 cm for participants aged \>12 years); Severe (\>7 cm for participants aged 6 to \<12 years and \>10 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). Report of severe swelling was confirmed as data entry error.
Outcome measures
| Measure |
13vPnC, 23vPS (All Participants)
n=120 Participants
Participants \>=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
|
13vPnC, 23vPS (Adult Participants)
n=123 Participants
Participants \>=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
|
13vPnC, 23vPS (All Participants)
n=243 Participants
Participants \>=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
|
|---|---|---|---|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 1
Redness: Mild (n = 91, 88, 179)
|
19.8 percentage of participants
|
2.3 percentage of participants
|
11.2 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 1
Redness: Moderate (n = 85, 88, 173)
|
2.4 percentage of participants
|
0.0 percentage of participants
|
1.2 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 1
Swelling: Mild (n = 91, 93, 184)
|
17.6 percentage of participants
|
8.6 percentage of participants
|
13.0 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 1
Swelling: Moderate (n = 92, 89, 181)
|
16.3 percentage of participants
|
1.1 percentage of participants
|
8.8 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 1
Pain at Injection Site: Any (n = 117, 121, 238)
|
68.4 percentage of participants
|
62.8 percentage of participants
|
65.5 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 1
Pain at Injection Site: Moderate (n = 94, 94, 188)
|
28.7 percentage of participants
|
18.1 percentage of participants
|
23.4 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 1
Redness: Any (n = 92, 88, 180)
|
20.7 percentage of participants
|
2.3 percentage of participants
|
11.7 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 1
Redness: Severe (n = 84, 88, 172)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 1
Swelling: Any (n = 97, 94, 191)
|
29.9 percentage of participants
|
9.6 percentage of participants
|
19.9 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 1
Swelling: Severe (n = 84, 88, 172)
|
1.2 percentage of participants
|
0.0 percentage of participants
|
0.6 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 1
Pain at Injection Site: Mild (n = 112, 116, 228)
|
55.4 percentage of participants
|
56.0 percentage of participants
|
55.7 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 1
Pain at Injection Site: Severe (n = 86, 89, 175)
|
8.1 percentage of participants
|
2.2 percentage of participants
|
5.1 percentage of participants
|
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 cm for participants aged 6 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 6 to \<12 years and 5.1 to 10.0 cm for participants aged \>12 years); Severe (\>7 cm for participants aged 6 to \<12 years and \>10 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=120 Participants
Participants \>=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
|
13vPnC, 23vPS (Adult Participants)
n=119 Participants
Participants \>=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
|
13vPnC, 23vPS (All Participants)
n=239 Participants
Participants \>=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
|
|---|---|---|---|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 2
Redness: Severe (n = 93, 85, 178)
|
1.1 percentage of participants
|
0.0 percentage of participants
|
0.6 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 2
Redness: Any (n = 101, 86, 187)
|
13.9 percentage of participants
|
2.3 percentage of participants
|
8.6 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 2
Redness: Mild (n = 100, 86, 186)
|
10.0 percentage of participants
|
2.3 percentage of participants
|
6.5 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 2
Redness: Moderate (n = 95, 85, 180)
|
4.2 percentage of participants
|
0.0 percentage of participants
|
2.2 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 2
Swelling: Any (n = 103, 88, 191)
|
25.2 percentage of participants
|
8.0 percentage of participants
|
17.3 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 2
Swelling: Mild (n = 102, 88, 190)
|
18.6 percentage of participants
|
8.0 percentage of participants
|
13.7 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 2
Swelling: Moderate (n = 99, 85, 184)
|
12.1 percentage of participants
|
0.0 percentage of participants
|
6.5 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 2
Swelling: Severe (n = 93, 85, 178)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 2
Pain at Injection Site: Any (n = 117, 119, 236)
|
60.7 percentage of participants
|
79.8 percentage of participants
|
70.3 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 2
Pain at Injection Site: Mild (n = 110, 117, 227)
|
49.1 percentage of participants
|
72.6 percentage of participants
|
61.2 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 2
Pain at Injection Site: Moderate (n= 103, 96, 199)
|
24.3 percentage of participants
|
27.1 percentage of participants
|
25.6 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 2
Pain at Injection Site: Severe (n = 93, 86, 179)
|
5.4 percentage of participants
|
3.5 percentage of participants
|
4.5 percentage of participants
|
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 cm for participants aged 6 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 6 to \<12 years and 5.1 to 10.0 cm for participants aged \>12 years); Severe (\>7 cm for participants aged 6 to \<12 years and \>10 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=104 Participants
Participants \>=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
|
13vPnC, 23vPS (Adult Participants)
n=109 Participants
Participants \>=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
|
13vPnC, 23vPS (All Participants)
n=213 Participants
Participants \>=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
|
|---|---|---|---|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 3
Swelling: Any (n = 89, 71, 160)
|
18.0 percentage of participants
|
4.2 percentage of participants
|
11.9 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 3
Swelling: Moderate (n = 84, 70, 154)
|
9.5 percentage of participants
|
0.0 percentage of participants
|
5.2 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 3
Redness: Any (n = 84, 70, 154)
|
8.3 percentage of participants
|
0.0 percentage of participants
|
4.5 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 3
Redness: Mild (n = 83, 70, 153)
|
7.2 percentage of participants
|
0.0 percentage of participants
|
3.9 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 3
Redness: Moderate (n = 82, 70, 152)
|
2.4 percentage of participants
|
0.0 percentage of participants
|
1.3 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 3
Redness: Severe (n = 80, 70, 150)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 3
Swelling: Mild (n = 86, 71, 157)
|
10.5 percentage of participants
|
4.2 percentage of participants
|
7.6 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 3
Swelling: Severe (n = 80, 70, 150)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 3
Pain at Injection Site: Any (n = 104, 109, 213)
|
52.9 percentage of participants
|
69.7 percentage of participants
|
61.5 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 3
Pain at Injection Site: Mild (n = 96, 105, 201)
|
41.7 percentage of participants
|
63.8 percentage of participants
|
53.2 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 3
Pain at Injection Site: Moderate (n = 89, 78, 167)
|
19.1 percentage of participants
|
24.4 percentage of participants
|
21.6 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 3
Pain at Injection Site: Severe (n = 83, 73, 156)
|
4.8 percentage of participants
|
5.5 percentage of participants
|
5.1 percentage of participants
|
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). All reporting of fever \>40 degrees C except 2 participants and all reporting of severe vomiting, after 13vPnC Dose 1, were confirmed as data entry errors.
Outcome measures
| Measure |
13vPnC, 23vPS (All Participants)
n=128 Participants
Participants \>=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
|
13vPnC, 23vPS (Adult Participants)
n=138 Participants
Participants \>=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
|
13vPnC, 23vPS (All Participants)
n=266 Participants
Participants \>=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
|
|---|---|---|---|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1
Diarrhea: Severe (n = 85, 88, 173)
|
1.2 percentage of participants
|
1.1 percentage of participants
|
1.2 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1
Use of Medication to Treat Pain (n = 101, 96, 197)
|
33.7 percentage of participants
|
24.0 percentage of participants
|
28.9 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1
Fever: >=38 degrees C (n= 94, 95, 189)
|
19.1 percentage of participants
|
17.9 percentage of participants
|
18.5 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1
Fever: >=38, <38.5 degrees C (n = 87, 92, 179)
|
8.0 percentage of participants
|
8.7 percentage of participants
|
8.4 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1
Fever: >=38.5, <39 degrees C (n = 85, 89, 174)
|
2.4 percentage of participants
|
3.4 percentage of participants
|
2.9 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1
Fever: >=39, =<40 degrees C (n = 86, 88, 174)
|
4.7 percentage of participants
|
2.3 percentage of participants
|
3.4 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1
Fever: >40 degrees C (n = 88, 93, 181)
|
6.8 percentage of participants
|
8.6 percentage of participants
|
7.7 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1
Fatigue: Any (n = 111, 119, 230)
|
47.7 percentage of participants
|
58.8 percentage of participants
|
53.5 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1
Fatigue: Mild (n = 105, 113, 218)
|
33.3 percentage of participants
|
51.3 percentage of participants
|
42.7 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1
Fatigue: Moderate (n = 96, 99, 195)
|
26.0 percentage of participants
|
28.3 percentage of participants
|
27.2 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1
Fatigue: Severe (n = 86, 92, 178)
|
9.3 percentage of participants
|
8.7 percentage of participants
|
9.0 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1
Headache: Any (n = 107, 113, 220)
|
39.3 percentage of participants
|
61.1 percentage of participants
|
50.5 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1
Headache: Mild (n = 100, 109, 209)
|
33.0 percentage of participants
|
57.8 percentage of participants
|
45.9 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1
Headache: Moderate (n = 94, 97, 191)
|
18.1 percentage of participants
|
22.7 percentage of participants
|
20.4 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1
Headache: Severe (n = 87, 89, 176)
|
6.9 percentage of participants
|
9.0 percentage of participants
|
8.0 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1
Vomiting: Any (n = 89, 91, 180)
|
18.0 percentage of participants
|
7.7 percentage of participants
|
12.8 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1
Vomiting: Mild (n = 89, 91, 180)
|
14.6 percentage of participants
|
7.7 percentage of participants
|
11.1 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1
Vomiting: Moderate (n = 84, 88, 172)
|
2.4 percentage of participants
|
0.0 percentage of participants
|
1.2 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1
Vomiting: Severe (n = 85, 88, 173)
|
2.4 percentage of participants
|
0.0 percentage of participants
|
1.2 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1
Diarrhea: Any (n = 94, 105, 199)
|
25.5 percentage of participants
|
34.3 percentage of participants
|
30.2 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1
Diarrhea: Mild (n = 92, 104, 196)
|
19.6 percentage of participants
|
29.8 percentage of participants
|
25.0 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1
Diarrhea: Moderate (n = 86, 91, 177)
|
8.1 percentage of participants
|
7.7 percentage of participants
|
7.9 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1
Muscle Pain: Any (n = 108, 118, 226)
|
48.1 percentage of participants
|
62.7 percentage of participants
|
55.8 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1
Muscle Pain: Mild (n = 103, 110, 213)
|
36.9 percentage of participants
|
56.4 percentage of participants
|
46.9 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1
Muscle Pain: Moderate (n = 89, 98, 187)
|
19.1 percentage of participants
|
19.4 percentage of participants
|
19.3 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1
Muscle Pain: Severe (n = 86, 91, 177)
|
5.8 percentage of participants
|
5.5 percentage of participants
|
5.6 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1
Joint Pain: Any (n = 100, 105, 205)
|
34.0 percentage of participants
|
42.9 percentage of participants
|
38.5 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1
Joint Pain: Mild (n = 98, 101, 199)
|
26.5 percentage of participants
|
36.6 percentage of participants
|
31.7 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1
Joint Pain: Moderate (n = 89, 95, 184)
|
12.4 percentage of participants
|
17.9 percentage of participants
|
15.2 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1
Joint Pain: Severe (n = 84, 91, 175)
|
4.8 percentage of participants
|
4.4 percentage of participants
|
4.6 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1
Use of Medication to Treat Fever (n=112, 107, 219)
|
44.6 percentage of participants
|
39.3 percentage of participants
|
42.0 percentage of participants
|
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). All reporting of fever \>40 degrees C and all reporting of severe vomiting, after 13vPnC Dose 2, were confirmed as data entry errors.
Outcome measures
| Measure |
13vPnC, 23vPS (All Participants)
n=123 Participants
Participants \>=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
|
13vPnC, 23vPS (Adult Participants)
n=120 Participants
Participants \>=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
|
13vPnC, 23vPS (All Participants)
n=243 Participants
Participants \>=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
|
|---|---|---|---|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2
Fever: >=39, =<40 degrees C (n = 97, 87, 184)
|
7.2 percentage of participants
|
3.4 percentage of participants
|
5.4 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2
Vomiting: Severe (n = 94, 85, 179)
|
3.2 percentage of participants
|
0.0 percentage of participants
|
1.7 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2
Fever: >=38 degrees C (n= 102, 88, 190)
|
16.7 percentage of participants
|
11.4 percentage of participants
|
14.2 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2
Fever: >=38, <38.5 degrees C (n = 96, 87, 183)
|
7.3 percentage of participants
|
9.2 percentage of participants
|
8.2 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2
Fever: >=38.5, <39 degrees C (n = 98, 85, 183)
|
6.1 percentage of participants
|
1.2 percentage of participants
|
3.8 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2
Fever: >40 degrees C (n = 95, 85, 180)
|
1.1 percentage of participants
|
1.2 percentage of participants
|
1.1 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2
Fatigue: Any (n = 106, 105, 211)
|
33.0 percentage of participants
|
48.6 percentage of participants
|
40.8 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2
Fatigue: Mild (n = 104, 103, 207)
|
24.0 percentage of participants
|
42.7 percentage of participants
|
33.3 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2
Diarrhea: Moderate (n = 93, 87, 180)
|
3.2 percentage of participants
|
8.0 percentage of participants
|
5.6 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2
Fatigue: Moderate (n = 96, 88, 184)
|
10.4 percentage of participants
|
21.6 percentage of participants
|
15.8 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2
Fatigue: Severe (n = 95, 88, 183)
|
7.4 percentage of participants
|
5.7 percentage of participants
|
6.6 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2
Headache: Any (n = 101, 106, 207)
|
28.7 percentage of participants
|
49.1 percentage of participants
|
39.1 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2
Headache: Mild (n = 97, 102, 199)
|
18.6 percentage of participants
|
40.2 percentage of participants
|
29.6 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2
Headache: Moderate (n = 97, 93, 190)
|
13.4 percentage of participants
|
28.0 percentage of participants
|
20.5 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2
Headache: Severe (n = 94, 88, 182)
|
2.1 percentage of participants
|
3.4 percentage of participants
|
2.7 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2
Vomiting: Any (n = 96, 89, 185)
|
10.4 percentage of participants
|
10.1 percentage of participants
|
10.3 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2
Vomiting: Mild (n = 94, 89, 183)
|
6.4 percentage of participants
|
9.0 percentage of participants
|
7.7 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2
Vomiting: Moderate (n = 94, 85, 179)
|
3.2 percentage of participants
|
1.2 percentage of participants
|
2.2 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2
Diarrhea: Any (n = 95, 95, 190)
|
10.5 percentage of participants
|
26.3 percentage of participants
|
18.4 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2
Diarrhea: Mild (n = 94, 93, 187)
|
7.4 percentage of participants
|
24.7 percentage of participants
|
16.0 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2
Diarrhea: Severe (n = 94, 85, 179)
|
4.3 percentage of participants
|
1.2 percentage of participants
|
2.8 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2
Muscle Pain: Any (n = 112, 104, 216)
|
37.5 percentage of participants
|
52.9 percentage of participants
|
44.9 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2
Muscle Pain: Mild (n = 105, 103, 208)
|
25.7 percentage of participants
|
46.6 percentage of participants
|
36.1 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2
Muscle Pain: Moderate (n = 100, 91, 191)
|
15.0 percentage of participants
|
20.9 percentage of participants
|
17.8 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2
Muscle Pain: Severe (n = 95, 85, 180)
|
5.3 percentage of participants
|
2.4 percentage of participants
|
3.9 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2
Joint Pain: Any (n = 106, 95, 201)
|
26.4 percentage of participants
|
34.7 percentage of participants
|
30.3 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2
Joint Pain: Mild (n = 100, 93, 193)
|
16.0 percentage of participants
|
29.0 percentage of participants
|
22.3 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2
Joint Pain: Moderate (n = 99, 89, 188)
|
11.1 percentage of participants
|
12.4 percentage of participants
|
11.7 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2
Joint Pain: Severe (n = 94, 85, 179)
|
4.3 percentage of participants
|
2.4 percentage of participants
|
3.4 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2
Use of Medication to Treat Pain (n = 100, 91, 191)
|
20.0 percentage of participants
|
17.6 percentage of participants
|
18.8 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2
Use of Medication to Treat Fever (n=102, 96, 198)
|
28.4 percentage of participants
|
26.0 percentage of participants
|
27.3 percentage of participants
|
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). All reporting of fever \>40 degrees C except 1 participant and all reporting of severe vomiting, after 13vPnC Dose 3, were confirmed as data entry errors.
Outcome measures
| Measure |
13vPnC, 23vPS (All Participants)
n=106 Participants
Participants \>=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
|
13vPnC, 23vPS (Adult Participants)
n=113 Participants
Participants \>=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
|
13vPnC, 23vPS (All Participants)
n=219 Participants
Participants \>=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
|
|---|---|---|---|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3
Vomiting: Moderate (n = 82, 73, 155)
|
2.4 percentage of participants
|
5.5 percentage of participants
|
3.9 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3
Diarrhea: Moderate (n = 80, 73, 153)
|
1.3 percentage of participants
|
6.8 percentage of participants
|
3.9 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3
Joint Pain: Mild (n = 88, 82, 170)
|
15.9 percentage of participants
|
28.0 percentage of participants
|
21.8 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3
Use of Medication to Treat Pain (n = 90, 79, 169)
|
17.8 percentage of participants
|
21.5 percentage of participants
|
19.5 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3
Fatigue: Mild (n = 89, 88, 177)
|
20.2 percentage of participants
|
39.8 percentage of participants
|
29.9 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3
Fatigue: Moderate (n = 83, 80, 163)
|
6.0 percentage of participants
|
25.0 percentage of participants
|
15.3 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3
Fatigue: Severe (n = 83, 73, 156)
|
4.8 percentage of participants
|
8.2 percentage of participants
|
6.4 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3
Headache: Any (n = 88, 89, 177)
|
18.2 percentage of participants
|
46.1 percentage of participants
|
32.2 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3
Headache: Mild (n = 84, 87, 171)
|
10.7 percentage of participants
|
41.4 percentage of participants
|
26.3 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3
Headache: Moderate (n = 83, 77, 160)
|
8.4 percentage of participants
|
19.5 percentage of participants
|
13.8 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3
Headache: Severe (n = 82, 72, 154)
|
3.7 percentage of participants
|
6.9 percentage of participants
|
5.2 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3
Vomiting: Any (n = 85, 74, 159)
|
8.2 percentage of participants
|
9.5 percentage of participants
|
8.8 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3
Vomiting: Mild (n = 84, 72, 156)
|
7.1 percentage of participants
|
5.6 percentage of participants
|
6.4 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3
Vomiting: Severe (n = 81, 72, 153)
|
1.2 percentage of participants
|
2.8 percentage of participants
|
2.0 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3
Diarrhea: Any (n = 81, 81, 162)
|
4.9 percentage of participants
|
28.4 percentage of participants
|
16.7 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3
Diarrhea: Mild (n = 81, 79, 160)
|
4.9 percentage of participants
|
25.3 percentage of participants
|
15.0 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3
Diarrhea: Severe (n = 81, 73, 154)
|
1.2 percentage of participants
|
4.1 percentage of participants
|
2.6 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3
Muscle Pain: Any (n = 99, 92, 191)
|
37.4 percentage of participants
|
47.8 percentage of participants
|
42.4 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3
Muscle Pain: Mild (n = 93, 89, 182)
|
25.8 percentage of participants
|
37.1 percentage of participants
|
31.3 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3
Muscle Pain: Moderate (n = 85, 78, 163)
|
12.9 percentage of participants
|
24.4 percentage of participants
|
18.4 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3
Muscle Pain: Severe (n = 84, 72, 156)
|
8.3 percentage of participants
|
5.6 percentage of participants
|
7.1 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3
Joint Pain: Any (n = 91, 83, 174)
|
24.2 percentage of participants
|
32.5 percentage of participants
|
28.2 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3
Joint Pain: Moderate (n = 82, 77, 159)
|
7.3 percentage of participants
|
15.6 percentage of participants
|
11.3 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3
Joint Pain: Severe (n = 81, 71, 152)
|
2.5 percentage of participants
|
2.8 percentage of participants
|
2.6 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3
Use of Medication to Treat Fever (n = 89, 75, 164)
|
20.2 percentage of participants
|
20.0 percentage of participants
|
20.1 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3
Fever: >=38 degrees C (n= 85, 73, 158)
|
10.6 percentage of participants
|
11.0 percentage of participants
|
10.8 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3
Fever: >=38, <38.5 degrees C (n = 82, 73, 155)
|
6.1 percentage of participants
|
5.5 percentage of participants
|
5.8 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3
Fever: >=38.5, <39 degrees C (n = 81, 72, 153)
|
2.5 percentage of participants
|
5.6 percentage of participants
|
3.9 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3
Fever: >=39, =<40 degrees C (n = 82, 70, 152)
|
2.4 percentage of participants
|
2.9 percentage of participants
|
2.6 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3
Fever: >40 degrees C (n = 83, 70, 153)
|
3.6 percentage of participants
|
1.4 percentage of participants
|
2.6 percentage of participants
|
|
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3
Fatigue: Any (n = 92, 91, 183)
|
25.0 percentage of participants
|
47.3 percentage of participants
|
36.1 percentage of participants
|
Adverse Events
Prior 13vPnC Dose 1
Serious events: 1 serious events
Other events: 16 other events
Deaths: 0 deaths
13vPnC Dose 1
Serious events: 1 serious events
Other events: 216 other events
Deaths: 0 deaths
13vPnC Dose 2
Serious events: 4 serious events
Other events: 171 other events
Deaths: 0 deaths
13vPnC Dose 3
Serious events: 1 serious events
Other events: 137 other events
Deaths: 0 deaths
23vPS Dose
Serious events: 0 serious events
Other events: 31 other events
Deaths: 0 deaths
Follow-up
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Prior 13vPnC Dose 1
n=301 participants at risk
Participants \>=6 years of age (all participants) who received at least 1 of 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose), assessed between signing of informed consent form and before 13vPnC Dose 1.
|
13vPnC Dose 1
n=301 participants at risk
Participants \>=6 years of age (all participants) who received a single dose of 0.5 mL of 13vPnC intramuscularly on Day 1 (13vPnC Dose 1), assessed between 13vPnC Dose 1 and before 13vPnC Dose 2.
|
13vPnC Dose 2
n=290 participants at risk
Participants \>=6 years of age (all participants) who received a single dose of 0.5 mL of 13vPnC intramuscularly 1 month after 13vPnC Dose 1 (13vPnC Dose 2), assessed between 13vPnC Dose 2 and before 13vPnC Dose 3.
|
13vPnC Dose 3
n=286 participants at risk
Participants \>=6 years of age (all participants) who received a single dose of 0.5 mL of 13vPnC intramuscularly 1 month after 13vPnC Dose 2 (13vPnC Dose 3), assessed between 13vPnC Dose 3 and before 23vPS Dose.
|
23vPS Dose
n=282 participants at risk
Participants \>=6 years of age (all participants) who received a single dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose), assessed between 23vPS Dose and before 23vPS Dose blood draw 1 month after 23vPS Dose.
|
Follow-up
n=282 participants at risk
Participants \>=6 years of age (all participants) who received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose), assessed from 23vPS blood draw to the 6-month follow-up telephone contact after 13vPnC Dose 3.
|
|---|---|---|---|---|---|---|
|
Nervous system disorders
Convulsion
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.33%
1/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/290 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/286 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/282 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/282 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.34%
1/290 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/286 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/282 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/282 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.34%
1/290 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/286 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/282 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/282 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Infections and infestations
Pharyngitis bacterial
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.34%
1/290 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/286 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/282 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.35%
1/282 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.34%
1/290 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/286 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/282 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/282 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/290 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.35%
1/286 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/282 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/282 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.33%
1/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/290 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/286 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/282 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/282 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Infections and infestations
Croup infectious
|
0.33%
1/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/290 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/286 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/282 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/282 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
Other adverse events
| Measure |
Prior 13vPnC Dose 1
n=301 participants at risk
Participants \>=6 years of age (all participants) who received at least 1 of 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose), assessed between signing of informed consent form and before 13vPnC Dose 1.
|
13vPnC Dose 1
n=301 participants at risk
Participants \>=6 years of age (all participants) who received a single dose of 0.5 mL of 13vPnC intramuscularly on Day 1 (13vPnC Dose 1), assessed between 13vPnC Dose 1 and before 13vPnC Dose 2.
|
13vPnC Dose 2
n=290 participants at risk
Participants \>=6 years of age (all participants) who received a single dose of 0.5 mL of 13vPnC intramuscularly 1 month after 13vPnC Dose 1 (13vPnC Dose 2), assessed between 13vPnC Dose 2 and before 13vPnC Dose 3.
|
13vPnC Dose 3
n=286 participants at risk
Participants \>=6 years of age (all participants) who received a single dose of 0.5 mL of 13vPnC intramuscularly 1 month after 13vPnC Dose 2 (13vPnC Dose 3), assessed between 13vPnC Dose 3 and before 23vPS Dose.
|
23vPS Dose
n=282 participants at risk
Participants \>=6 years of age (all participants) who received a single dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose), assessed between 23vPS Dose and before 23vPS Dose blood draw 1 month after 23vPS Dose.
|
Follow-up
n=282 participants at risk
Participants \>=6 years of age (all participants) who received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose), assessed from 23vPS blood draw to the 6-month follow-up telephone contact after 13vPnC Dose 3.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Gastroduodenitis
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/290 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/186 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/282 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.55%
1/182 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
General disorders
Fatigue
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
1.00%
3/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/290 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/186 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/282 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/182 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Eye disorders
Conjunctivitis
|
0.33%
1/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.33%
1/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/290 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/186 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.35%
1/282 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/182 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.33%
1/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/290 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/186 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/282 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/182 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Gastrointestinal disorders
Salivary gland enlargement
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.33%
1/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/290 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/186 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/282 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/182 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.33%
1/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/290 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/186 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/282 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/182 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/290 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.54%
1/186 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/282 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/182 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/290 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.54%
1/186 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/282 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/182 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/290 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.54%
1/186 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/282 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/182 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/290 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/186 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.35%
1/282 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/182 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/290 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/186 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.35%
1/282 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/182 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
General disorders
Pyrexia
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.66%
2/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.69%
2/290 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/186 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.35%
1/282 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/182 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
General disorders
Influenza like illness
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.34%
1/290 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/186 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/282 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/182 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
General disorders
Injection site pain
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/290 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.54%
1/186 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
2.1%
6/282 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/182 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
General disorders
Injection site reaction
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/290 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/186 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.71%
2/282 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/182 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
General disorders
Injection site swelling
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/290 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/186 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.71%
2/282 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/182 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
General disorders
Vaccination site swelling
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/290 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/186 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.71%
2/282 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/182 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Infections and infestations
Influenza
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
1.7%
5/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.34%
1/290 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
4.3%
8/186 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
1.1%
3/282 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.55%
1/182 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
1.00%
3/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/290 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/186 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/282 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/182 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.0%
6/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
1.00%
3/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
1.4%
4/290 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.54%
1/186 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/282 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/182 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.66%
2/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.34%
1/290 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.54%
1/186 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.35%
1/282 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.55%
1/182 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Infections and infestations
Cystitis
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.33%
1/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/290 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/186 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/282 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/182 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Infections and infestations
Herpes virus infection
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.33%
1/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/290 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/186 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/282 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/182 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.33%
1/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.34%
1/290 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/186 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/282 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/182 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Infections and infestations
Otitis media
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.33%
1/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/290 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.54%
1/186 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/282 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/182 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.33%
1/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/290 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.54%
1/186 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/282 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/182 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Infections and infestations
Rhinitis
|
0.33%
1/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.33%
1/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.69%
2/290 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
2.2%
4/186 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.71%
2/282 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/182 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.33%
1/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/290 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/186 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/282 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/182 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Infections and infestations
Viraemia
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.33%
1/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/290 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/186 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/282 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/182 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Infections and infestations
Tinea capitis
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.33%
1/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/290 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/186 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/282 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/182 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Infections and infestations
Tonsillitis
|
0.33%
1/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.33%
1/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/290 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
1.1%
2/186 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/282 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/182 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.33%
1/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/290 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/186 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/282 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/182 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Infections and infestations
Body tinea
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.34%
1/290 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/186 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/282 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/182 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.34%
1/290 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/186 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/282 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/182 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.34%
1/290 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.54%
1/186 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.35%
1/282 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.55%
1/182 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Infections and infestations
Pharyngitis bacterial
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.34%
1/290 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.54%
1/186 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/282 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/182 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/290 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.54%
1/186 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/282 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/182 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Infections and infestations
Varicella
|
1.00%
3/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/290 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.54%
1/186 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/282 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/182 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Infections and infestations
Impetigo
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/290 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/186 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.35%
1/282 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/182 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/290 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/186 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.35%
1/282 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/182 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/290 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/186 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.35%
1/282 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/182 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/290 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/186 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/282 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.55%
1/182 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/290 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/186 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/282 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.55%
1/182 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.33%
1/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/290 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/186 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/282 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/182 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Injury, poisoning and procedural complications
Lip injury
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.34%
1/290 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/186 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/282 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/182 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.34%
1/290 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/186 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/282 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/182 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.33%
1/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/290 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
1.1%
2/186 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.35%
1/282 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/182 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.34%
1/290 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/186 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/282 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/182 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/290 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.54%
1/186 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.35%
1/282 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/182 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/290 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/186 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.35%
1/282 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/182 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/290 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/186 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.35%
1/282 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/182 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/290 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/186 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/282 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.55%
1/182 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/290 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.54%
1/186 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/282 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/182 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Nervous system disorders
Headache
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
1.00%
3/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.34%
1/290 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.54%
1/186 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.71%
2/282 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/182 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Nervous system disorders
Intercostal neuralgia
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/290 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.54%
1/186 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/282 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/182 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/290 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/186 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.35%
1/282 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/182 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.3%
4/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
1.3%
4/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
1.0%
3/290 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.54%
1/186 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
1.4%
4/282 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/182 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.33%
1/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/290 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
1.1%
2/186 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/282 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/182 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.33%
1/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.34%
1/290 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/186 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/282 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/182 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.34%
1/290 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/186 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/282 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/182 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.34%
1/290 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/186 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/282 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/182 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal disorder
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/290 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.54%
1/186 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/282 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/182 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.34%
1/290 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/186 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/282 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/182 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.33%
1/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/290 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/186 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/282 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/182 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Skin and subcutaneous tissue disorders
Exfoliative rash
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.33%
1/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/290 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/186 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/282 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/182 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/290 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
1.1%
2/186 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/282 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/182 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/290 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/186 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.35%
1/282 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/182 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/290 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/186 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.35%
1/282 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/182 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Vascular disorders
Hypertension
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.34%
1/290 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/186 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/282 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/182 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Skin and subcutaneous tissue disorders
Redness (Any)
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
11.7%
21/180 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
8.6%
16/187 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
4.5%
7/154 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Skin and subcutaneous tissue disorders
Redness (Mild)
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
11.2%
20/179 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
6.5%
12/186 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
3.9%
6/153 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Skin and subcutaneous tissue disorders
Redness (Moderate)
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
1.2%
2/173 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
2.2%
4/180 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
1.3%
2/152 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Skin and subcutaneous tissue disorders
Redness (Severe)
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/172 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.56%
1/178 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/150 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Skin and subcutaneous tissue disorders
Swelling (Any)
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
19.9%
38/191 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
17.3%
33/191 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
11.9%
19/160 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Skin and subcutaneous tissue disorders
Swelling (Mild)
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
13.0%
24/184 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
13.7%
26/190 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
7.6%
12/157 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Skin and subcutaneous tissue disorders
Swelling (Moderate)
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
8.8%
16/181 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
6.5%
12/184 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
5.2%
8/154 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Skin and subcutaneous tissue disorders
Swelling (Severe)
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.58%
1/172 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/178 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/150 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Skin and subcutaneous tissue disorders
Pain at injection site (Any)
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
65.5%
156/238 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
70.3%
166/236 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
61.5%
131/213 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Skin and subcutaneous tissue disorders
Pain at injection site (Mild)
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
55.7%
127/228 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
61.2%
139/227 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
53.2%
107/201 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Skin and subcutaneous tissue disorders
Pain at injection site (Moderate)
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
23.4%
44/188 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
25.6%
51/199 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
21.6%
36/167 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Skin and subcutaneous tissue disorders
Pain at injection site (Severe)
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
5.1%
9/175 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
4.5%
8/179 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
5.1%
8/156 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
General disorders
Fever (≥38°C)
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
18.5%
35/189 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
14.2%
27/190 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
10.8%
17/158 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
General disorders
Fever (≥38°C but <38.5°C)
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
8.4%
15/179 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
8.2%
15/183 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
5.8%
9/155 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
General disorders
Fever (≥38.5°C but <39°C)
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
2.9%
5/174 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
3.8%
7/183 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
3.9%
6/153 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
General disorders
Fever (≥39°C but ≤40°C)
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
3.4%
6/174 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
5.4%
10/184 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
2.6%
4/152 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
General disorders
Fever (>40°C)
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
7.7%
14/181 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
1.1%
2/180 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
2.6%
4/153 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
General disorders
Fatigue (Any)
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
53.5%
123/230 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
40.8%
86/211 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
36.1%
66/183 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
General disorders
Fatigue (Mild)
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
42.7%
93/218 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
33.3%
69/207 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
29.9%
53/177 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
General disorders
Fatigue (Moderate)
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
27.2%
53/195 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
15.8%
29/184 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
15.3%
25/163 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
General disorders
Fatigue (Severe)
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
9.0%
16/178 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
6.6%
12/183 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
6.4%
10/156 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
General disorders
Headache (Any)
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
50.5%
111/220 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
39.1%
81/207 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
32.2%
57/177 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
General disorders
Headache (Mild)
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
45.9%
96/209 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
29.6%
59/199 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
26.3%
45/171 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
General disorders
Headache (Moderate)
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
20.4%
39/191 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
20.5%
39/190 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
13.8%
22/160 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
General disorders
Headache (Severe)
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
8.0%
14/176 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
2.7%
5/182 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
5.2%
8/154 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
General disorders
Vomiting (Any)
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
12.8%
23/180 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
10.3%
19/185 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
8.8%
14/159 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
General disorders
Vomiting (Mild)
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
11.1%
20/180 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
7.7%
14/183 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
6.4%
10/156 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
General disorders
Vomiting (Moderate)
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
1.2%
2/172 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
2.2%
4/179 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
3.9%
6/155 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
General disorders
Vomiting (Severe)
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
1.2%
2/173 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
1.7%
3/179 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
2.0%
3/153 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
General disorders
Diarrhea (Any)
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
30.2%
60/199 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
18.4%
35/190 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
16.7%
27/162 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
General disorders
Diarrhea (Mild)
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
25.0%
49/196 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
16.0%
30/187 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
15.0%
24/160 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
General disorders
Diarrhea (Moderate)
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
7.9%
14/177 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
5.6%
10/180 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
3.9%
6/153 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
General disorders
Diarrhea (Severe)
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
1.2%
2/173 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
2.8%
5/179 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
2.6%
4/154 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
General disorders
Muscle pain (Any)
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
55.8%
126/226 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
44.9%
97/216 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
42.4%
81/191 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
General disorders
Muscle pain (Mild)
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
46.9%
100/213 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
36.1%
75/208 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
31.3%
57/182 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
General disorders
Muscle pain (Moderate)
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
19.3%
36/187 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
17.8%
34/191 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
18.4%
30/163 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
General disorders
Muscle pain (Severe)
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
5.6%
10/177 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
3.9%
7/180 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
7.1%
11/156 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
General disorders
Joint pain (Any)
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
38.5%
79/205 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
30.3%
61/201 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
28.2%
49/174 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
General disorders
Joint pain (Mild)
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
31.7%
63/199 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
22.3%
43/193 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
21.8%
37/170 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
General disorders
Joint pain (Moderate)
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
15.2%
28/184 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
11.7%
22/188 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
11.3%
18/159 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
General disorders
Joint pain (Severe)
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
4.6%
8/175 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
3.4%
6/179 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
2.6%
4/152 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Nervous system disorders
Dizziness
|
0.33%
1/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/290 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/286 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/282 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/282 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Psychiatric disorders
Abnormal dreams
|
0.33%
1/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/290 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/286 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/282 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/282 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Psychiatric disorders
Agitation
|
0.33%
1/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/290 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/286 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/282 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/282 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Psychiatric disorders
Depression
|
0.33%
1/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/290 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/286 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/282 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/282 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.33%
1/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/290 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/286 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/282 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/282 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Infections and infestations
Parotitis
|
0.33%
1/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/301 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/290 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/286 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/282 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/282 • Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
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