Trial Outcomes & Findings for Study Evaluating 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in Children With Sickle Cell Disease (NCT NCT00918580)
NCT ID: NCT00918580
Last Updated: 2014-04-21
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 1 to 1 month after 13vPnC Dose 2 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 1 and after 13vPnC Dose 2 blood draws. Here number of participants analyzed signifies the evaluable immunogenicity population and "N" signifies participants with a determinate IgG antibody concentration for the given serotype at both 1 Month After 13vPnC Dose 1 and 1 Month After 13vPnC Dose 2 blood draws. Participants may be represented in more than 1 category.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
158 participants
Primary outcome timeframe
1 Month After 13vPnC Dose 1, 1 Month After 13vPnC Dose 2
Results posted on
2014-04-21
Participant Flow
Participant milestones
| Measure |
13vPnC
Participants previously immunized with 23-valent pneumococcal polysaccharide vaccine (23vPS) received 2 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection, 6 months apart.
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|---|---|
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Up to 6-month Follow-up(FU)
STARTED
|
158
|
|
Up to 6-month Follow-up(FU)
Vaccinated Dose 1
|
158
|
|
Up to 6-month Follow-up(FU)
Vaccinated Dose 2
|
146
|
|
Up to 6-month Follow-up(FU)
COMPLETED
|
147
|
|
Up to 6-month Follow-up(FU)
NOT COMPLETED
|
11
|
|
After 6-month FU to 1-year FU
STARTED
|
147
|
|
After 6-month FU to 1-year FU
Continued After 6-Month FU
|
89
|
|
After 6-month FU to 1-year FU
COMPLETED
|
87
|
|
After 6-month FU to 1-year FU
NOT COMPLETED
|
60
|
Reasons for withdrawal
| Measure |
13vPnC
Participants previously immunized with 23-valent pneumococcal polysaccharide vaccine (23vPS) received 2 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection, 6 months apart.
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|---|---|
|
Up to 6-month Follow-up(FU)
Adverse Event
|
1
|
|
Up to 6-month Follow-up(FU)
Lost to Follow-up
|
5
|
|
Up to 6-month Follow-up(FU)
Withdrawal by Subject
|
2
|
|
Up to 6-month Follow-up(FU)
Parent/Legal Guardian Request
|
2
|
|
Up to 6-month Follow-up(FU)
Failed to Return
|
1
|
|
After 6-month FU to 1-year FU
Did Not Continue After 6-Month FU
|
58
|
|
After 6-month FU to 1-year FU
Failed to Return
|
2
|
Baseline Characteristics
Study Evaluating 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in Children With Sickle Cell Disease
Baseline characteristics by cohort
| Measure |
13vPnC
n=158 Participants
Participants previously immunized with 23-valent pneumococcal polysaccharide vaccine (23vPS) received 2 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection, 6 months apart.
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|---|---|
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Age, Continuous
|
13.3 years
STANDARD_DEVIATION 3.08 • n=93 Participants
|
|
Sex: Female, Male
Female
|
76 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
82 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 1 Month After 13vPnC Dose 1, 1 Month After 13vPnC Dose 2Population: Evaluable immunogenicity population: eligible participants who received all study vaccinations; had valid and determinate assay result; had blood drawn within pre-specified time-frames; had no major protocol violation (including use of prohibited vaccine/medication, immunoglobulins or chronic systemic corticosteroids).
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 1 to 1 month after 13vPnC Dose 2 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 1 and after 13vPnC Dose 2 blood draws. Here number of participants analyzed signifies the evaluable immunogenicity population and "N" signifies participants with a determinate IgG antibody concentration for the given serotype at both 1 Month After 13vPnC Dose 1 and 1 Month After 13vPnC Dose 2 blood draws. Participants may be represented in more than 1 category.
Outcome measures
| Measure |
13vPnC
n=138 Participants
Participants previously immunized with 23-valent pneumococcal polysaccharide vaccine (23vPS) received 2 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection, 6 months apart.
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|---|---|
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Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From 1 Month After 13vPnC Dose 1 to 1 Month After 13vPnC Dose 2
Serotype 4 (N = 137)
|
0.75 fold rise
Interval 0.66 to 0.84
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|
Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From 1 Month After 13vPnC Dose 1 to 1 Month After 13vPnC Dose 2
Serotype 6B (N = 136)
|
0.89 fold rise
Interval 0.78 to 1.02
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|
Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From 1 Month After 13vPnC Dose 1 to 1 Month After 13vPnC Dose 2
Serotype 9V (N = 136)
|
0.82 fold rise
Interval 0.75 to 0.91
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|
Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From 1 Month After 13vPnC Dose 1 to 1 Month After 13vPnC Dose 2
Serotype 14 (N = 137)
|
0.75 fold rise
Interval 0.67 to 0.85
|
|
Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From 1 Month After 13vPnC Dose 1 to 1 Month After 13vPnC Dose 2
Serotype 18C (N = 137)
|
0.70 fold rise
Interval 0.62 to 0.8
|
|
Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From 1 Month After 13vPnC Dose 1 to 1 Month After 13vPnC Dose 2
Serotype 19F (N = 136)
|
1.05 fold rise
Interval 0.91 to 1.2
|
|
Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From 1 Month After 13vPnC Dose 1 to 1 Month After 13vPnC Dose 2
Serotype 23F (N = 135)
|
0.91 fold rise
Interval 0.77 to 1.08
|
|
Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From 1 Month After 13vPnC Dose 1 to 1 Month After 13vPnC Dose 2
Serotype 1 (N = 137)
|
0.88 fold rise
Interval 0.77 to 0.99
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|
Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From 1 Month After 13vPnC Dose 1 to 1 Month After 13vPnC Dose 2
Serotype 3 (N = 134)
|
0.82 fold rise
Interval 0.75 to 0.9
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|
Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From 1 Month After 13vPnC Dose 1 to 1 Month After 13vPnC Dose 2
Serotype 5 (N = 136)
|
0.90 fold rise
Interval 0.82 to 0.98
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|
Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From 1 Month After 13vPnC Dose 1 to 1 Month After 13vPnC Dose 2
Serotype 6A (N = 136)
|
0.95 fold rise
Interval 0.82 to 1.1
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|
Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From 1 Month After 13vPnC Dose 1 to 1 Month After 13vPnC Dose 2
Serotype 7F (N = 137)
|
0.75 fold rise
Interval 0.67 to 0.85
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|
Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From 1 Month After 13vPnC Dose 1 to 1 Month After 13vPnC Dose 2
Serotype 19A (N = 137)
|
0.83 fold rise
Interval 0.74 to 0.93
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SECONDARY outcome
Timeframe: Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1Population: Evaluable immunogenicity population: eligible participants who received all study vaccinations; had valid and determinate assay result; had blood drawn within pre-specified time-frames; had no major protocol violation (including use of prohibited vaccine/medication, immunoglobulins or chronic systemic corticosteroids).
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. 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 before 13vPnC Dose 1 and 1 month after 13vPnC Dose 1 blood draws. Here number of participants analyzed signifies the evaluable immunogenicity population and "N" signifies participants with determinate IgG antibody concentration for the given serotype at both the before 13vPnC Dose 1 and 1 month after 13vPnC Dose 1 blood draws. Participants may be represented in more than 1 category.
Outcome measures
| Measure |
13vPnC
n=138 Participants
Participants previously immunized with 23-valent pneumococcal polysaccharide vaccine (23vPS) received 2 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection, 6 months apart.
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|---|---|
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Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1
Serotype 4 (N = 136)
|
6.91 fold rise
Interval 5.27 to 9.06
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|
Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1
Serotype 6B (N = 137)
|
4.72 fold rise
Interval 3.8 to 5.85
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|
Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1
Serotype 9V (N = 138)
|
3.10 fold rise
Interval 2.6 to 3.7
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|
Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1
Serotype 14 (N = 138)
|
5.50 fold rise
Interval 4.05 to 7.46
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|
Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1
Serotype 18C (N = 137)
|
5.58 fold rise
Interval 4.47 to 6.97
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|
Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1
Serotype 19F (N = 134)
|
4.76 fold rise
Interval 3.77 to 6.03
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|
Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1
Serotype 23F (N = 137)
|
6.58 fold rise
Interval 5.12 to 8.46
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|
Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1
Serotype 1 (N = 129)
|
3.60 fold rise
Interval 2.9 to 4.46
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|
Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1
Serotype 3 (N = 133)
|
2.03 fold rise
Interval 1.78 to 2.31
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|
Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1
Serotype 5 (N = 138)
|
1.74 fold rise
Interval 1.56 to 1.94
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|
Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1
Serotype 6A (N = 132)
|
4.10 fold rise
Interval 3.32 to 5.05
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|
Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1
Serotype 7F (N = 137)
|
4.38 fold rise
Interval 3.62 to 5.3
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|
Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1
Serotype 19A (N = 138)
|
3.28 fold rise
Interval 2.73 to 3.96
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SECONDARY outcome
Timeframe: Before 13vPnC Dose 2, 1 month after 13vPnC Dose 2Population: Evaluable immunogenicity population: eligible participants who received all study vaccinations; had valid and determinate assay result; had blood drawn within pre-specified time-frames; had no major protocol violation (including use of prohibited vaccine/medication, immunoglobulins or chronic systemic corticosteroids).
GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from before 13vPnC Dose 2 to 1 month after 13vPnC Dose 2 were computed using the logarithmically transformed assay results. CI for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from before 13vPnC Dose 2 and 1 month after 13vPnC Dose 2 blood draws. Here number of participants analyzed signifies the evaluable immunogenicity population and "N" signifies participants with determinate IgG antibody concentration for the given serotype at both the before 13vPnC Dose 2 and 1 month after 13vPnC Dose 2 blood draws. Participants may be represented in more than 1 category.
Outcome measures
| Measure |
13vPnC
n=138 Participants
Participants previously immunized with 23-valent pneumococcal polysaccharide vaccine (23vPS) received 2 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection, 6 months apart.
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|---|---|
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Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From Before 13vPnC Dose 2 to 1 Month After 13vPnC Dose 2
Serotype 4 (N = 137)
|
1.86 fold rise
Interval 1.69 to 2.04
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|
Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From Before 13vPnC Dose 2 to 1 Month After 13vPnC Dose 2
Serotype 6B (N = 137)
|
1.80 fold rise
Interval 1.6 to 2.03
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|
Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From Before 13vPnC Dose 2 to 1 Month After 13vPnC Dose 2
Serotype 9V (N = 136)
|
1.48 fold rise
Interval 1.37 to 1.59
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|
Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From Before 13vPnC Dose 2 to 1 Month After 13vPnC Dose 2
Serotype 14 (N = 137)
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1.24 fold rise
Interval 1.15 to 1.35
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|
Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From Before 13vPnC Dose 2 to 1 Month After 13vPnC Dose 2
Serotype 18C (N = 137)
|
1.47 fold rise
Interval 1.34 to 1.62
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|
Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From Before 13vPnC Dose 2 to 1 Month After 13vPnC Dose 2
Serotype 19F (N = 135)
|
2.08 fold rise
Interval 1.85 to 2.34
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|
Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From Before 13vPnC Dose 2 to 1 Month After 13vPnC Dose 2
Serotype 23F (N = 135)
|
2.04 fold rise
Interval 1.75 to 2.37
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|
Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From Before 13vPnC Dose 2 to 1 Month After 13vPnC Dose 2
Serotype 1 (N = 136)
|
1.73 fold rise
Interval 1.57 to 1.92
|
|
Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From Before 13vPnC Dose 2 to 1 Month After 13vPnC Dose 2
Serotype 3 (N = 133)
|
1.36 fold rise
Interval 1.25 to 1.47
|
|
Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From Before 13vPnC Dose 2 to 1 Month After 13vPnC Dose 2
Serotype 5 (N = 135)
|
1.30 fold rise
Interval 1.22 to 1.39
|
|
Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From Before 13vPnC Dose 2 to 1 Month After 13vPnC Dose 2
Serotype 6A (N = 133)
|
1.80 fold rise
Interval 1.6 to 2.02
|
|
Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From Before 13vPnC Dose 2 to 1 Month After 13vPnC Dose 2
Serotype 7F (N = 137)
|
1.75 fold rise
Interval 1.61 to 1.9
|
|
Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From Before 13vPnC Dose 2 to 1 Month After 13vPnC Dose 2
Serotype 19A (N = 137)
|
1.48 fold rise
Interval 1.36 to 1.61
|
SECONDARY outcome
Timeframe: Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1, before 13vPnC Dose 2, 1 month after 13vPnC Dose 2Population: Evaluable immunogenicity population: eligible participants who received all study vaccinations; had valid and determinate assay result; had blood drawn within pre-specified time-frames; had no major protocol violation (including use of prohibited vaccine/medication, immunoglobulins or chronic systemic corticosteroids).
GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were computed using the logarithmically transformed assay results for Dose 1 (after Dose 1/before Dose 1) and for Dose 2 (after Dose 2/before Dose 2). CI for the ratio of GMFR (Dose 2/Dose 1) were back transformations of a CI based on the Student t distribution for the mean logarithm of the measures (Dose 2 - Dose 1). Here number of participants analyzed signifies the evaluable immunogenicity population and "N" signifies participants with determinate IgG antibody concentration for given serotype at before 13vPnC Dose 1, 1 month after 13vPnC Dose 1, before 13vPnC Dose 2 and 1 month after 13vPnC Dose 2 blood draws. Participants may be represented in more than 1 category.
Outcome measures
| Measure |
13vPnC
n=138 Participants
Participants previously immunized with 23-valent pneumococcal polysaccharide vaccine (23vPS) received 2 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection, 6 months apart.
|
|---|---|
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Ratio of Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From 13vPnC Dose 1 to 13vPnC Dose 2
Serotype 4 (N = 135)
|
0.26 ratio of GMFR
Interval 0.2 to 0.35
|
|
Ratio of Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From 13vPnC Dose 1 to 13vPnC Dose 2
Serotype 6B (N = 136)
|
0.38 ratio of GMFR
Interval 0.29 to 0.49
|
|
Ratio of Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From 13vPnC Dose 1 to 13vPnC Dose 2
Serotype 9V (N = 136)
|
0.49 ratio of GMFR
Interval 0.41 to 0.59
|
|
Ratio of Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From 13vPnC Dose 1 to 13vPnC Dose 2
Serotype 14 (N = 137)
|
0.22 ratio of GMFR
Interval 0.16 to 0.31
|
|
Ratio of Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From 13vPnC Dose 1 to 13vPnC Dose 2
Serotype 18C (N = 136)
|
0.26 ratio of GMFR
Interval 0.21 to 0.34
|
|
Ratio of Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From 13vPnC Dose 1 to 13vPnC Dose 2
Serotype 19F (N = 132)
|
0.44 ratio of GMFR
Interval 0.34 to 0.57
|
|
Ratio of Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From 13vPnC Dose 1 to 13vPnC Dose 2
Serotype 23F (N = 135)
|
0.32 ratio of GMFR
Interval 0.24 to 0.43
|
|
Ratio of Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From 13vPnC Dose 1 to 13vPnC Dose 2
Serotype 1 (N = 127)
|
0.47 ratio of GMFR
Interval 0.37 to 0.59
|
|
Ratio of Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From 13vPnC Dose 1 to 13vPnC Dose 2
Serotype 3 (N = 130)
|
0.66 ratio of GMFR
Interval 0.58 to 0.75
|
|
Ratio of Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From 13vPnC Dose 1 to 13vPnC Dose 2
Serotype 5 (N = 135)
|
0.75 ratio of GMFR
Interval 0.66 to 0.85
|
|
Ratio of Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From 13vPnC Dose 1 to 13vPnC Dose 2
Serotype 6A (N = 127)
|
0.45 ratio of GMFR
Interval 0.35 to 0.58
|
|
Ratio of Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From 13vPnC Dose 1 to 13vPnC Dose 2
Serotype 7F (N = 136)
|
0.39 ratio of GMFR
Interval 0.32 to 0.49
|
|
Ratio of Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From 13vPnC Dose 1 to 13vPnC Dose 2
Serotype 19A (N = 137)
|
0.45 ratio of GMFR
Interval 0.36 to 0.55
|
SECONDARY outcome
Timeframe: Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1, before 13vPnC Dose 2, 1 month after 13vPnC Dose 2Population: Evaluable immunogenicity population: eligible participants who received all study vaccinations; had valid and determinate assay result; had blood drawn within pre-specified time-frames; had no major protocol violation (including use of prohibited vaccine/medication, immunoglobulins or chronic systemic corticosteroids).
Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) are presented. GMC (13vPnC) and corresponding 2-sided 95 percent (%) CIs were evaluated. Geometric means were calculated using all participants with available data for the specified blood draw. CI for GMC were back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. Here number of participants analyzed signifies the evaluable immunogenicity population and "N" signifies participants with determinate IgG antibody concentration for the given serotype at specified time point. Participants may be represented in more than 1 category.
Outcome measures
| Measure |
13vPnC
n=138 Participants
Participants previously immunized with 23-valent pneumococcal polysaccharide vaccine (23vPS) received 2 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection, 6 months apart.
|
|---|---|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody
Before 13vPnC Dose 1: Serotype 4 (N = 136)
|
1.01 microgram per milliliter (mcg/mL)
Interval 0.8 to 1.27
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody
Before 13vPnC Dose 1: Serotype 6B (N = 138)
|
5.79 microgram per milliliter (mcg/mL)
Interval 4.89 to 6.87
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody
Before 13vPnC Dose 1: Serotype 9V (N = 138)
|
3.01 microgram per milliliter (mcg/mL)
Interval 2.56 to 3.53
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody
Before 13vPnC Dose 1: Serotype 14 (N = 138)
|
6.30 microgram per milliliter (mcg/mL)
Interval 4.78 to 8.3
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody
Before 13vPnC Dose 1: Serotype 18C (N = 137)
|
1.40 microgram per milliliter (mcg/mL)
Interval 1.14 to 1.73
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody
Before 13vPnC Dose 1: Serotype 19F (N = 134)
|
4.46 microgram per milliliter (mcg/mL)
Interval 3.6 to 5.53
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody
Before 13vPnC Dose 1: Serotype 23F (N = 138)
|
2.80 microgram per milliliter (mcg/mL)
Interval 2.38 to 3.3
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody
Before 13vPnC Dose 1: Serotype 1 (N = 129)
|
1.57 microgram per milliliter (mcg/mL)
Interval 1.26 to 1.95
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody
Before 13vPnC Dose 1: Serotype 3 (N = 133)
|
1.02 microgram per milliliter (mcg/mL)
Interval 0.83 to 1.25
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody
Before 13vPnC Dose 1: Serotype 5 (N = 138)
|
4.14 microgram per milliliter (mcg/mL)
Interval 3.58 to 4.78
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody
Before 13vPnC Dose 1: Serotype 6A (N = 132)
|
4.62 microgram per milliliter (mcg/mL)
Interval 3.91 to 5.46
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody
Before 13vPnC Dose 1: Serotype 7F (N = 137)
|
2.16 microgram per milliliter (mcg/mL)
Interval 1.8 to 2.59
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody
Before 13vPnC Dose 1: Serotype 19A (N = 138)
|
8.16 microgram per milliliter (mcg/mL)
Interval 7.03 to 9.48
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody
1 Month After 13vPnC Dose 1: Serotype 4 (N = 138)
|
6.85 microgram per milliliter (mcg/mL)
Interval 5.55 to 8.44
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody
1 Month After 13vPnC Dose 1: Serotype 6B (N= 137)
|
27.25 microgram per milliliter (mcg/mL)
Interval 22.09 to 33.61
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody
1 Month After 13vPnC Dose 1: Serotype 9V (N= 138)
|
9.31 microgram per milliliter (mcg/mL)
Interval 7.83 to 11.07
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody
1 Month After 13vPnC Dose 1: Serotype 14 (N = 138)
|
34.63 microgram per milliliter (mcg/mL)
Interval 27.77 to 43.18
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody
1 Month After 13vPnC Dose 1: Serotype 18C (N= 138)
|
7.83 microgram per milliliter (mcg/mL)
Interval 6.42 to 9.54
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody
1 Month After 13vPnC Dose 1: Serotype 19F (N= 138)
|
20.40 microgram per milliliter (mcg/mL)
Interval 16.03 to 25.95
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody
1 Month After 13vPnC Dose 1: Serotype 23F (N= 137)
|
18.25 microgram per milliliter (mcg/mL)
Interval 14.52 to 22.95
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody
1 Month After 13vPnC Dose 1: Serotype 1 (N = 138)
|
5.24 microgram per milliliter (mcg/mL)
Interval 4.3 to 6.39
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody
1 Month After 13vPnC Dose 1: Serotype 3 (N = 138)
|
2.04 microgram per milliliter (mcg/mL)
Interval 1.76 to 2.38
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody
1 Month After 13vPnC Dose 1: Serotype 5 (N = 138)
|
7.19 microgram per milliliter (mcg/mL)
Interval 6.19 to 8.35
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody
1 Month After 13vPnC Dose 1: Serotype 6A (N = 138)
|
17.61 microgram per milliliter (mcg/mL)
Interval 14.16 to 21.91
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody
1 Month After 13vPnC Dose 1: Serotype 7F (N = 138)
|
9.46 microgram per milliliter (mcg/mL)
Interval 8.17 to 10.94
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody
1 Month After 13vPnC Dose 1: Serotype 19A (N= 138)
|
26.82 microgram per milliliter (mcg/mL)
Interval 22.16 to 32.46
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody
Before 13vPnC Dose 2: Serotype 4 (N = 138)
|
2.77 microgram per milliliter (mcg/mL)
Interval 2.29 to 3.35
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody
Before 13vPnC Dose 2: Serotype 6B (N = 138)
|
13.67 microgram per milliliter (mcg/mL)
Interval 11.23 to 16.63
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody
Before 13vPnC Dose 2: Serotype 9V (N = 138)
|
5.19 microgram per milliliter (mcg/mL)
Interval 4.41 to 6.09
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody
Before 13vPnC Dose 2: Serotype 14 (N = 138)
|
21.07 microgram per milliliter (mcg/mL)
Interval 17.29 to 25.67
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody
Before 13vPnC Dose 2: Serotype 18C (N = 138)
|
3.73 microgram per milliliter (mcg/mL)
Interval 3.1 to 4.49
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody
Before 13vPnC Dose 2: Serotype 19F (N = 137)
|
10.34 microgram per milliliter (mcg/mL)
Interval 8.32 to 12.85
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody
Before 13vPnC Dose 2: Serotype 23F (N = 137)
|
8.07 microgram per milliliter (mcg/mL)
Interval 6.63 to 9.83
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody
Before 13vPnC Dose 2: Serotype 1 (N = 137)
|
2.65 microgram per milliliter (mcg/mL)
Interval 2.21 to 3.19
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody
Before 13vPnC Dose 2: Serotype 3 (N = 135)
|
1.27 microgram per milliliter (mcg/mL)
Interval 1.06 to 1.52
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody
Before 13vPnC Dose 2: Serotype 5 (N = 137)
|
4.91 microgram per milliliter (mcg/mL)
Interval 4.26 to 5.66
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody
Before 13vPnC Dose 2: Serotype 6A (N = 135)
|
9.05 microgram per milliliter (mcg/mL)
Interval 7.48 to 10.95
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody
Before 13vPnC Dose 2: Serotype 7F (N = 138)
|
4.09 microgram per milliliter (mcg/mL)
Interval 3.52 to 4.74
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody
Before 13vPnC Dose 2: Serotype 19A (N = 138)
|
15.13 microgram per milliliter (mcg/mL)
Interval 12.73 to 17.98
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody
1 Month After 13vPnC Dose 2: Serotype 4 (N = 137)
|
5.09 microgram per milliliter (mcg/mL)
Interval 4.28 to 6.04
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody
1 Month After 13vPnC Dose 2: Serotype 6B (N= 137)
|
24.52 microgram per milliliter (mcg/mL)
Interval 20.48 to 29.35
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody
1 Month After 13vPnC Dose 2: Serotype 9V (N= 136)
|
7.46 microgram per milliliter (mcg/mL)
Interval 6.46 to 8.61
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody
1 Month After 13vPnC Dose 2: Serotype 14 (N = 137)
|
26.19 microgram per milliliter (mcg/mL)
Interval 22.11 to 31.03
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody
1 Month After 13vPnC Dose 2: Serotype 18C (N= 137)
|
5.44 microgram per milliliter (mcg/mL)
Interval 4.64 to 6.38
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody
1 Month After 13vPnC Dose 2: Serotype 19F (N= 136)
|
20.56 microgram per milliliter (mcg/mL)
Interval 17.15 to 24.63
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody
1 Month After 13vPnC Dose 2: Serotype 23F (N= 135)
|
16.18 microgram per milliliter (mcg/mL)
Interval 13.27 to 19.73
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody
1 Month After 13vPnC Dose 2: Serotype 1 (N = 137)
|
4.51 microgram per milliliter (mcg/mL)
Interval 3.82 to 5.32
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody
1 Month After 13vPnC Dose 2: Serotype 3 (N = 134)
|
1.67 microgram per milliliter (mcg/mL)
Interval 1.42 to 1.97
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody
1 Month After 13vPnC Dose 2: Serotype 5 (N = 136)
|
6.33 microgram per milliliter (mcg/mL)
Interval 5.58 to 7.17
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody
1 Month After 13vPnC Dose 2: Serotype 6A (N = 136)
|
16.37 microgram per milliliter (mcg/mL)
Interval 13.65 to 19.64
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody
1 Month After 13vPnC Dose 2: Serotype 7F (N = 137)
|
7.06 microgram per milliliter (mcg/mL)
Interval 6.2 to 8.04
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody
1 Month After 13vPnC Dose 2: Serotype 19A (N= 137)
|
22.19 microgram per milliliter (mcg/mL)
Interval 18.94 to 25.99
|
SECONDARY outcome
Timeframe: 1 year after 13vPnC Dose 2Population: Evaluable immunogenicity population at 1-year follow-up: eligible participants who received all study vaccinations; had valid and determinate assay result; had blood drawn within pre-specified time-frames; had no major protocol violation (including use of prohibited vaccine/medication, immunoglobulins or chronic systemic corticosteroids).
Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) are presented. GMC (13vPnC) and corresponding 2-sided 95 percent (%) CIs were evaluated. Geometric means were calculated using all participants with available data for the specified blood draw. CI for GMC were back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. Here number of participants analyzed signifies the evaluable immunogenicity population at 1-year follow-up and "N" signifies participants with determinate IgG antibody concentration for the given serotype. Participants may be represented in more than 1 category.
Outcome measures
| Measure |
13vPnC
n=81 Participants
Participants previously immunized with 23-valent pneumococcal polysaccharide vaccine (23vPS) received 2 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection, 6 months apart.
|
|---|---|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Year After 13vPnC Dose 2
Serotype 3 (N = 67)
|
1.01 mcg/mL
Interval 0.77 to 1.33
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Year After 13vPnC Dose 2
Serotype 5 (N = 81)
|
4.38 mcg/mL
Interval 3.58 to 5.37
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Year After 13vPnC Dose 2
Serotype 4 (N = 81)
|
1.94 mcg/mL
Interval 1.51 to 2.48
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Year After 13vPnC Dose 2
Serotype 6B (N = 81)
|
11.77 mcg/mL
Interval 9.43 to 14.71
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Year After 13vPnC Dose 2
Serotype 9V (N = 81)
|
4.50 mcg/mL
Interval 3.61 to 5.62
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Year After 13vPnC Dose 2
Serotype 14 (N = 81)
|
15.89 mcg/mL
Interval 12.47 to 20.26
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Year After 13vPnC Dose 2
Serotype 18C (N = 81)
|
2.64 mcg/mL
Interval 2.03 to 3.42
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Year After 13vPnC Dose 2
Serotype 19F (N = 81)
|
9.87 mcg/mL
Interval 7.5 to 13.0
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Year After 13vPnC Dose 2
Serotype 23F (N = 81)
|
7.70 mcg/mL
Interval 6.15 to 9.63
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Year After 13vPnC Dose 2
Serotype 1 (N = 79)
|
2.12 mcg/mL
Interval 1.65 to 2.71
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Year After 13vPnC Dose 2
Serotype 6A (N = 81)
|
7.94 mcg/mL
Interval 6.45 to 9.77
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Year After 13vPnC Dose 2
Serotype 7F (N = 81)
|
3.47 mcg/mL
Interval 2.84 to 4.25
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Year After 13vPnC Dose 2
Serotype 19A (N = 81)
|
13.30 mcg/mL
Interval 10.62 to 16.65
|
SECONDARY outcome
Timeframe: Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1, before 13vPnC Dose 2, 1 month after 13vPnC Dose 2Population: Evaluable immunogenicity population: eligible participants who received all study vaccinations; had valid and determinate assay result; had blood drawn within pre-specified time-frames; had no major protocol violation (including use of prohibited vaccine/medication, immunoglobulins or chronic systemic corticosteroids).
Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). GMT and corresponding 2-sided 95% CIs were evaluated. CIs for the GMTs are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the titers. GMTs were calculated using all participants with available data for the specified blood draw. Here number of participants analyzed signifies the evaluable immunogenicity population and "N" signifies participants with determinate OPA antibody titer for the given serotype at specified time point. Participants may be represented in more than 1 category.
Outcome measures
| Measure |
13vPnC
n=138 Participants
Participants previously immunized with 23-valent pneumococcal polysaccharide vaccine (23vPS) received 2 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection, 6 months apart.
|
|---|---|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT)
1 Month After 13vPnC Dose 1: Serotype 23F (N= 106)
|
1607 titer
Interval 1227.4 to 2102.7
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT)
1 Month After 13vPnC Dose 1: Serotype 1 (N = 123)
|
56 titer
Interval 41.0 to 77.4
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT)
1 Month After 13vPnC Dose 1: Serotype 3 (N = 112)
|
115 titer
Interval 93.0 to 142.1
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT)
1 Month After 13vPnC Dose 1: Serotype 5 (N = 121)
|
277 titer
Interval 198.4 to 385.8
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT)
1 Month After 13vPnC Dose 1: Serotype 6A (N = 117)
|
7845 titer
Interval 6581.6 to 9349.9
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT)
1 Month After 13vPnC Dose 1: Serotype 7F (N = 123)
|
3348 titer
Interval 2881.9 to 3888.5
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT)
1 Month After 13vPnC Dose 1: Serotype 19A (N =118)
|
1449 titer
Interval 1164.2 to 1804.3
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT)
Before 13vPnC Dose 2: Serotype 4 (N = 104)
|
1331 titer
Interval 1013.9 to 1748.1
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT)
Before 13vPnC Dose 2: Serotype 6B (N = 108)
|
4174 titer
Interval 3513.0 to 4958.3
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT)
Before 13vPnC Dose 2: Serotype 9V (N = 99)
|
1445 titer
Interval 1051.7 to 1985.5
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT)
Before 13vPnC Dose 2: Serotype 14 (N = 106)
|
1652 titer
Interval 1347.8 to 2024.1
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT)
Before 13vPnC Dose 2: Serotype 18C (N = 101)
|
1928 titer
Interval 1281.1 to 2901.0
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT)
Before 13vPnC Dose 2: Serotype 19F (N = 92)
|
516 titer
Interval 338.8 to 785.5
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT)
Before 13vPnC Dose 2: Serotype 23F (N = 94)
|
897 titer
Interval 619.0 to 1300.4
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT)
Before 13vPnC Dose 2: Serotype 1 (N = 107)
|
23 titer
Interval 17.1 to 32.3
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT)
Before 13vPnC Dose 2: Serotype 3 (N = 120)
|
56 titer
Interval 45.5 to 69.9
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT)
Before 13vPnC Dose 2: Serotype 5 (N = 107)
|
98 titer
Interval 69.2 to 140.2
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT)
Before 13vPnC Dose 2: Serotype 6A (N = 113)
|
4005 titer
Interval 3350.6 to 4786.3
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT)
Before 13vPnC Dose 2: Serotype 7F (N = 112)
|
1791 titer
Interval 1427.0 to 2248.6
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT)
Before 13vPnC Dose 2: Serotype 19A (N = 108)
|
677 titer
Interval 544.4 to 843.1
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT)
1 Month After 13vPnC Dose 2: Serotype 4 (N = 105)
|
3051 titer
Interval 2536.7 to 3670.3
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT)
1 Month After 13vPnC Dose 2: Serotype 6B (N= 107)
|
7601 titer
Interval 6392.6 to 9038.6
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT)
1 Month After 13vPnC Dose 2: Serotype 9V (N = 96)
|
3467 titer
Interval 2784.0 to 4317.6
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT)
1 Month After 13vPnC Dose 2: Serotype 14 (N = 110)
|
2081 titer
Interval 1770.5 to 2446.0
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT)
1 Month After 13vPnC Dose 2: Serotype 18C (N= 103)
|
5271 titer
Interval 4267.8 to 6510.1
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT)
1 Month After 13vPnC Dose 2: Serotype 19F (N = 89)
|
1507 titer
Interval 1139.9 to 1992.2
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT)
1 Month After 13vPnC Dose 2: Serotype 23F (N= 105)
|
2330 titer
Interval 1880.4 to 2887.0
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT)
1 Month After 13vPnC Dose 2: Serotype 1 (N = 106)
|
78 titer
Interval 59.5 to 101.2
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT)
1 Month After 13vPnC Dose 2: Serotype 3 (N = 109)
|
105 titer
Interval 87.2 to 127.2
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT)
1 Month After 13vPnC Dose 2: Serotype 5 (N = 118)
|
273 titer
Interval 213.9 to 349.2
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT)
1 Month After 13vPnC Dose 2: Serotype 6A (N = 111)
|
7633 titer
Interval 6439.6 to 9048.6
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT)
1 Month After 13vPnC Dose 2: Serotype 7F (N = 114)
|
3723 titer
Interval 3276.2 to 4230.1
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT)
1 Month After 13vPnC Dose 2: Serotype 19A (N= 115)
|
1314 titer
Interval 1084.4 to 1592.6
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT)
Before 13vPnC Dose 1: Serotype 4 (N = 105)
|
215 titer
Interval 129.6 to 357.2
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT)
Before 13vPnC Dose 1: Serotype 6B (N = 105)
|
626 titer
Interval 377.5 to 1037.4
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT)
Before 13vPnC Dose 1: Serotype 9V (N = 109)
|
234 titer
Interval 137.6 to 398.7
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT)
Before 13vPnC Dose 1: Serotype 14 (N = 115)
|
628 titer
Interval 425.8 to 925.7
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT)
Before 13vPnC Dose 1: Serotype 18C (N = 95)
|
426 titer
Interval 235.7 to 771.4
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT)
Before 13vPnC Dose 1: Serotype 19F (N = 96)
|
94 titer
Interval 55.0 to 160.7
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT)
Before 13vPnC Dose 1: Serotype 23F (N = 106)
|
34 titer
Interval 21.5 to 54.8
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT)
Before 13vPnC Dose 1: Serotype 1 (N = 131)
|
7 titer
Interval 5.7 to 8.8
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT)
Before 13vPnC Dose 1: Serotype 3 (N = 107)
|
13 titer
Interval 10.1 to 17.5
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT)
Before 13vPnC Dose 1: Serotype 5 (N = 131)
|
10 titer
Interval 7.8 to 13.9
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT)
Before 13vPnC Dose 1: Serotype 6A (N = 116)
|
246 titer
Interval 149.0 to 404.8
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT)
Before 13vPnC Dose 1: Serotype 7F (N = 120)
|
344 titer
Interval 220.5 to 537.9
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT)
Before 13vPnC Dose 1: Serotype 19A (N = 127)
|
137 titer
Interval 100.0 to 187.4
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT)
1 Month After 13vPnC Dose 1: Serotype 4 (N = 108)
|
2670 titer
Interval 2128.1 to 3351.1
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT)
1 Month After 13vPnC Dose 1: Serotype 6B (N= 116)
|
7535 titer
Interval 6320.5 to 8983.5
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT)
1 Month After 13vPnC Dose 1: Serotype 9V (N= 103)
|
2312 titer
Interval 1684.0 to 3172.8
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT)
1 Month After 13vPnC Dose 1: Serotype 14 (N = 117)
|
2288 titer
Interval 1906.6 to 2745.0
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT)
1 Month After 13vPnC Dose 1: Serotype 18C (N= 103)
|
4326 titer
Interval 3250.3 to 5756.8
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT)
1 Month After 13vPnC Dose 1: Serotype 19F (N = 89)
|
1429 titer
Interval 1043.5 to 1957.3
|
SECONDARY outcome
Timeframe: 1 year after 13vPnC Dose 2Population: Evaluable immunogenicity population at 1-year follow-up: eligible participants who received all study vaccinations; had valid and determinate assay result; had blood drawn within pre-specified time-frames; had no major protocol violation (including use of prohibited vaccine/medication, immunoglobulins or chronic systemic corticosteroids).
Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). GMT and corresponding 2-sided 95% CIs were evaluated. CIs for the GMTs are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the titers. GMTs were calculated using all participants with available data for the specified blood draw. Here number of participants analyzed signifies the evaluable immunogenicity population at 1-year follow-up and "N" signifies participants with determinate OPA antibody titer for the given serotype. Participants may be represented in more than 1 category.
Outcome measures
| Measure |
13vPnC
n=81 Participants
Participants previously immunized with 23-valent pneumococcal polysaccharide vaccine (23vPS) received 2 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection, 6 months apart.
|
|---|---|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Year After 13vPnC Dose 2
Serotype 23F (N = 58)
|
924 titer
Interval 654.2 to 1306.1
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Year After 13vPnC Dose 2
Serotype 4 (N = 58)
|
1107 titer
Interval 764.4 to 1602.2
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Year After 13vPnC Dose 2
Serotype 6B (N = 59)
|
3412 titer
Interval 2746.4 to 4238.7
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Year After 13vPnC Dose 2
Serotype 9V (N = 66)
|
1690 titer
Interval 1157.8 to 2465.5
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Year After 13vPnC Dose 2
Serotype 14 (N = 64)
|
1595 titer
Interval 1281.6 to 1984.9
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Year After 13vPnC Dose 2
Serotype 18C (N = 59)
|
1604 titer
Interval 1107.2 to 2324.2
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Year After 13vPnC Dose 2
Serotype 19F (N = 55)
|
620 titer
Interval 376.6 to 1020.4
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Year After 13vPnC Dose 2
Serotype 1 (N = 73)
|
25 titer
Interval 17.5 to 35.4
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Year After 13vPnC Dose 2
Serotype 3 (N = 72)
|
31 titer
Interval 22.6 to 42.6
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Year After 13vPnC Dose 2
Serotype 5 (N = 71)
|
102 titer
Interval 70.5 to 148.0
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Year After 13vPnC Dose 2
Serotype 6A (N = 72)
|
2485 titer
Interval 1921.2 to 3214.3
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Year After 13vPnC Dose 2
Serotype 7F (N = 73)
|
2166 titer
Interval 1861.4 to 2519.3
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Year After 13vPnC Dose 2
Serotype 19A (N = 73)
|
589 titer
Interval 449.4 to 771.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Within 7 days after 13vPnC Dose 1Population: Safety population for Dose 1 included all participants who received Dose 1 of study vaccine and had safety data available.
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 (less than \<2.5 centimeters \[cm\] for participants aged 6 to \<12 years and 2.5 to 5.0 cm for participants aged greater than or equal to \[\>=\] 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 was scaled as: Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity). Here "Number of participants analyzed" signifies the safety population for Dose 1 and "N" signifies those participants who reported "Yes" for at least 1 day or "No" for all days for specified local reaction. Participants may be represented in more than 1 category.
Outcome measures
| Measure |
13vPnC
n=158 Participants
Participants previously immunized with 23-valent pneumococcal polysaccharide vaccine (23vPS) received 2 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection, 6 months apart.
|
|---|---|
|
Percentage of Participants With Prespecified Local Reactions: 13vPnC Dose 1
Pain: Any (N = 144)
|
89.6 percentage of participants
|
|
Percentage of Participants With Prespecified Local Reactions: 13vPnC Dose 1
Pain: Mild (N = 132)
|
81.8 percentage of participants
|
|
Percentage of Participants With Prespecified Local Reactions: 13vPnC Dose 1
Pain: Moderate (N = 113)
|
56.6 percentage of participants
|
|
Percentage of Participants With Prespecified Local Reactions: 13vPnC Dose 1
Pain: Severe (N = 90)
|
11.1 percentage of participants
|
|
Percentage of Participants With Prespecified Local Reactions: 13vPnC Dose 1
Redness: Any (N = 93)
|
23.7 percentage of participants
|
|
Percentage of Participants With Prespecified Local Reactions: 13vPnC Dose 1
Redness: Mild (N = 93)
|
20.4 percentage of participants
|
|
Percentage of Participants With Prespecified Local Reactions: 13vPnC Dose 1
Redness: Moderate (N = 90)
|
8.9 percentage of participants
|
|
Percentage of Participants With Prespecified Local Reactions: 13vPnC Dose 1
Redness: Severe (N = 87)
|
1.1 percentage of participants
|
|
Percentage of Participants With Prespecified Local Reactions: 13vPnC Dose 1
Swelling: Any (N = 108)
|
49.1 percentage of participants
|
|
Percentage of Participants With Prespecified Local Reactions: 13vPnC Dose 1
Swelling: Mild (N = 101)
|
37.6 percentage of participants
|
|
Percentage of Participants With Prespecified Local Reactions: 13vPnC Dose 1
Swelling: Moderate (N = 100)
|
26.0 percentage of participants
|
|
Percentage of Participants With Prespecified Local Reactions: 13vPnC Dose 1
Swelling: Severe (N = 87)
|
1.1 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Within 7 days after 13vPnC Dose 2Population: Safety population for Dose 2 included all participants who received Dose 2 of study vaccine and had safety data available.
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 (\<2.5 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 was scaled as: Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity). Here number of participants analyzed signifies the safety population for Dose 2 and "N" signifies those participants who reported "Yes" for at least 1 day or "No" for all days for specified local reaction. Participants may be represented in more than 1 category.
Outcome measures
| Measure |
13vPnC
n=140 Participants
Participants previously immunized with 23-valent pneumococcal polysaccharide vaccine (23vPS) received 2 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection, 6 months apart.
|
|---|---|
|
Percentage of Participants With Prespecified Local Reactions: 13vPnC Dose 2
Pain: Any (N = 111)
|
85.6 percentage of participants
|
|
Percentage of Participants With Prespecified Local Reactions: 13vPnC Dose 2
Pain: Mild (N = 103)
|
77.7 percentage of participants
|
|
Percentage of Participants With Prespecified Local Reactions: 13vPnC Dose 2
Pain: Moderate (N = 82)
|
53.7 percentage of participants
|
|
Percentage of Participants With Prespecified Local Reactions: 13vPnC Dose 2
Pain: Severe (N = 69)
|
15.9 percentage of participants
|
|
Percentage of Participants With Prespecified Local Reactions: 13vPnC Dose 2
Redness: Any (N = 67)
|
26.9 percentage of participants
|
|
Percentage of Participants With Prespecified Local Reactions: 13vPnC Dose 2
Redness: Mild (N = 66)
|
15.2 percentage of participants
|
|
Percentage of Participants With Prespecified Local Reactions: 13vPnC Dose 2
Redness: Moderate (N = 64)
|
14.1 percentage of participants
|
|
Percentage of Participants With Prespecified Local Reactions: 13vPnC Dose 2
Redness: Severe (N = 63)
|
0.0 percentage of participants
|
|
Percentage of Participants With Prespecified Local Reactions: 13vPnC Dose 2
Swelling: Any (N = 84)
|
53.6 percentage of participants
|
|
Percentage of Participants With Prespecified Local Reactions: 13vPnC Dose 2
Swelling: Mild (N = 77)
|
37.7 percentage of participants
|
|
Percentage of Participants With Prespecified Local Reactions: 13vPnC Dose 2
Swelling: Moderate (N = 73)
|
35.6 percentage of participants
|
|
Percentage of Participants With Prespecified Local Reactions: 13vPnC Dose 2
Swelling: Severe (N = 63)
|
0.0 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Within 7 days after 13vPnC Dose 1Population: Safety population for Dose 1 included all participants who received Dose 1 of study vaccine and had safety data available.
Specific systemic events (fever \>=38 degrees Celsius\[C\], vomiting, diarrhea, headache, fatigue, muscle pain, joint pain, use of antipyretic medications) 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); 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). Here number of participants analyzed signifies the safety population for Dose 1 and "N" signifies those participants who reported "Yes" for at least 1 day or "No" for all days for specified systemic event. Participants may be represented in more than 1 category.
Outcome measures
| Measure |
13vPnC
n=158 Participants
Participants previously immunized with 23-valent pneumococcal polysaccharide vaccine (23vPS) received 2 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection, 6 months apart.
|
|---|---|
|
Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 1
Fever: >=38, =<38.4 degrees C (N = 81)
|
13.6 percentage of participants
|
|
Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 1
Fever: >38.4, =<38.9 degrees C (N = 82)
|
7.3 percentage of participants
|
|
Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 1
Fever: >38.9, =<40 degrees C (N = 79)
|
3.8 percentage of participants
|
|
Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 1
Fever: >40 degrees C (N = 79)
|
1.3 percentage of participants
|
|
Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 1
Vomiting: Any (N = 91)
|
15.4 percentage of participants
|
|
Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 1
Vomiting: Mild (N = 89)
|
11.2 percentage of participants
|
|
Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 1
Vomiting: Moderate (N = 90)
|
6.7 percentage of participants
|
|
Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 1
Vomiting: Severe (N = 87)
|
0.0 percentage of participants
|
|
Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 1
Diarrhea: Any (N = 90)
|
13.3 percentage of participants
|
|
Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 1
Diarrhea: Mild (N = 87)
|
6.9 percentage of participants
|
|
Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 1
Diarrhea: Moderate (N = 90)
|
6.7 percentage of participants
|
|
Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 1
Diarrhea: Severe (N = 87)
|
2.3 percentage of participants
|
|
Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 1
Headache: Any (N = 110)
|
53.6 percentage of participants
|
|
Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 1
Headache: Mild (N = 105)
|
42.9 percentage of participants
|
|
Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 1
Headache: Moderate (N = 101)
|
34.7 percentage of participants
|
|
Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 1
Headache: Severe (N = 92)
|
12.0 percentage of participants
|
|
Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 1
Fatigue: Any (N = 118)
|
66.1 percentage of participants
|
|
Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 1
Fatigue: Mild (N = 108)
|
48.1 percentage of participants
|
|
Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 1
Fatigue: Moderate (N = 104)
|
44.2 percentage of participants
|
|
Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 1
Fatigue: Severe (N = 90)
|
14.4 percentage of participants
|
|
Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 1
Muscle Pain: Any (N = 127)
|
74.8 percentage of participants
|
|
Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 1
Muscle Pain: Mild (N = 114)
|
58.8 percentage of participants
|
|
Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 1
Muscle Pain: Moderate (N = 108)
|
47.2 percentage of participants
|
|
Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 1
Muscle Pain: Severe (N = 89)
|
10.1 percentage of participants
|
|
Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 1
Joint Pain: Any (N = 103)
|
39.8 percentage of participants
|
|
Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 1
Joint Pain: Mild (N = 98)
|
23.5 percentage of participants
|
|
Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 1
Joint Pain: Moderate (N = 94)
|
23.4 percentage of participants
|
|
Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 1
Joint Pain: Severe (N = 89)
|
4.5 percentage of participants
|
|
Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 1
Use of Antipyretic Medications (N = 110)
|
58.2 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Within 7 days after 13vPnC Dose 2Population: Safety population for Dose 2 included all participants who received Dose 2 of study vaccine and had safety data available.
Specific systemic events (fever \>=38 degrees C, vomiting, diarrhea, headache, fatigue, muscle pain, joint pain, and use of antipyretic medications) 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); 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). Here number of participants analyzed signifies the safety population for Dose 2 and "N" signifies those participants who reported "Yes" for at least 1 day or "No" for all days for specified systemic event. Participants may be represented in more than 1 category.
Outcome measures
| Measure |
13vPnC
n=140 Participants
Participants previously immunized with 23-valent pneumococcal polysaccharide vaccine (23vPS) received 2 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection, 6 months apart.
|
|---|---|
|
Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 2
Fever: >=38, =<38.4 degrees C (N = 63)
|
9.5 percentage of participants
|
|
Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 2
Fever: >38.4, =<38.9 degrees C (N = 59)
|
6.8 percentage of participants
|
|
Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 2
Fever: >38.9, =<40 degrees C (N = 63)
|
6.3 percentage of participants
|
|
Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 2
Fever: >40 degrees C (N = 60)
|
1.7 percentage of participants
|
|
Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 2
Vomiting: Any (N = 67)
|
13.4 percentage of participants
|
|
Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 2
Vomiting: Mild (N = 65)
|
9.2 percentage of participants
|
|
Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 2
Vomiting: Moderate (N = 64)
|
4.7 percentage of participants
|
|
Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 2
Vomiting: Severe (N = 64)
|
1.6 percentage of participants
|
|
Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 2
Diarrhea: Any (N = 68)
|
25.0 percentage of participants
|
|
Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 2
Diarrhea: Mild (N = 68)
|
19.1 percentage of participants
|
|
Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 2
Diarrhea: Moderate (N = 66)
|
12.1 percentage of participants
|
|
Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 2
Diarrhea: Severe (N = 63)
|
3.2 percentage of participants
|
|
Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 2
Headache: Any (N = 86)
|
59.3 percentage of participants
|
|
Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 2
Headache: Mild (N = 74)
|
41.9 percentage of participants
|
|
Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 2
Headache: Moderate (N = 76)
|
36.8 percentage of participants
|
|
Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 2
Headache: Severe (N = 66)
|
10.6 percentage of participants
|
|
Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 2
Fatigue: Any (N = 96)
|
62.5 percentage of participants
|
|
Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 2
Fatigue: Mild (N = 84)
|
48.8 percentage of participants
|
|
Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 2
Fatigue: Moderate (N = 83)
|
41.0 percentage of participants
|
|
Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 2
Fatigue: Severe (N = 67)
|
13.4 percentage of participants
|
|
Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 2
Muscle Pain: Any (N = 98)
|
75.5 percentage of participants
|
|
Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 2
Muscle Pain: Mild (N = 87)
|
60.9 percentage of participants
|
|
Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 2
Muscle Pain: Moderate (N = 84)
|
45.2 percentage of participants
|
|
Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 2
Muscle Pain: Severe (N = 67)
|
16.4 percentage of participants
|
|
Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 2
Joint Pain: Any (N = 78)
|
44.9 percentage of participants
|
|
Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 2
Joint Pain: Mild (N = 72)
|
34.7 percentage of participants
|
|
Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 2
Joint Pain: Moderate (N = 70)
|
21.4 percentage of participants
|
|
Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 2
Joint Pain: Severe (N = 65)
|
6.2 percentage of participants
|
|
Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 2
Use of Antipyretic Medications (N = 78)
|
43.6 percentage of participants
|
Adverse Events
13vPnC Dose 1
Serious events: 40 serious events
Other events: 133 other events
Deaths: 0 deaths
13vPnC Dose 2
Serious events: 11 serious events
Other events: 100 other events
Deaths: 0 deaths
6-Month Follow-up
Serious events: 28 serious events
Other events: 1 other events
Deaths: 0 deaths
1-Year Follow-up
Serious events: 16 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
13vPnC Dose 1
n=158 participants at risk
Participants previously immunized with 23vPS who received a single 0.5 mL dose of 13vPnC intramuscular injection on Day 1 (13vPnC Dose 1), assessed between 13vPnC Dose 1 and before 13vPnC Dose2.
|
13vPnC Dose 2
n=140 participants at risk
Participants previously immunized with 23vPS who received Dose 2 of 0.5 mL 13vPnC intramuscular injection, assessed between 13vPnC Dose 2 and before 13vPnC Dose 2 blood draw.
|
6-Month Follow-up
n=147 participants at risk
Participants previously immunized with 23vPS who received at least 1 of the 2 single 0.5 mL doses of 13vPnC intramuscular injection, 6 months apart, assessed from last 13vPnC Dose (Dose 1 or Dose 2) blood draw to the 6-month follow-up telephone contact.
|
1-Year Follow-up
n=87 participants at risk
Participants previously immunized with 23vPS who received 2 single 0.5 mL doses of 13vPnC intramuscular injection, 6 months apart, assessed from the 6-month follow-up telephone contact after 13vPnC Dose 2 to the 1-year follow-up after 13vPnC Dose 2.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.63%
1/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.63%
1/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.00%
0/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.68%
1/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Blood and lymphatic system disorders
Hypersplenism
|
0.00%
0/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.68%
1/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Congenital, familial and genetic disorders
Sickle cell anaemia with crisis
|
13.9%
22/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
3.6%
5/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
11.6%
17/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
12.6%
11/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Eye disorders
Visual impairment
|
0.63%
1/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.63%
1/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Gastrointestinal disorders
Constipation
|
0.63%
1/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Gastrointestinal disorders
Gastritis
|
0.63%
1/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Gastrointestinal disorders
Gingivitis
|
0.63%
1/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.63%
1/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Gastrointestinal disorders
Nausea
|
0.63%
1/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Gastrointestinal disorders
Oesophagitis
|
0.63%
1/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
General disorders
Pyrexia
|
3.2%
5/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
1.4%
2/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
3.4%
3/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
General disorders
Fatigue
|
0.63%
1/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
General disorders
Pain
|
0.63%
1/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
1.4%
2/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
1.1%
1/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
General disorders
Chest pain
|
0.00%
0/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.68%
1/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
General disorders
Oedema peripheral
|
0.00%
0/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
1.1%
1/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Hepatobiliary disorders
Cholecystitis
|
0.63%
1/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.63%
1/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
1.1%
1/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.63%
1/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Upper respiratory tract infection
|
1.3%
2/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Bacteraemia
|
0.63%
1/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Bronchitis
|
0.63%
1/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.68%
1/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
1.1%
1/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Device related infection
|
0.63%
1/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Osteomyelitis
|
0.63%
1/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
1.1%
1/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Pharyngitis
|
0.63%
1/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Pharyngotonsillitis
|
0.63%
1/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Pneumonia
|
0.63%
1/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
1.4%
2/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
4.6%
4/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Pyelonephritis
|
0.63%
1/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Tonsillitis
|
0.63%
1/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Urinary tract infection
|
0.63%
1/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
1.1%
1/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.68%
1/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
1.1%
1/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Groin abscess
|
0.00%
0/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.68%
1/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Hepatitis A
|
0.00%
0/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.68%
1/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Sinusitis
|
0.00%
0/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.68%
1/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.68%
1/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Bone abscess
|
0.00%
0/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
1.1%
1/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.63%
1/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.68%
1/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.68%
1/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.3%
2/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.68%
1/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.63%
1/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
1.4%
2/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.63%
1/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.71%
1/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.68%
1/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.68%
1/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.68%
1/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.68%
1/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Nervous system disorders
Headache
|
0.63%
1/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.68%
1/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Nervous system disorders
Lethargy
|
0.63%
1/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Nervous system disorders
Migraine
|
0.63%
1/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.68%
1/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.68%
1/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Nervous system disorders
Unresponsive to stimuli
|
0.00%
0/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.68%
1/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
1.1%
1/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.00%
0/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
1.4%
2/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Psychiatric disorders
Mental status changes
|
0.63%
1/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Renal and urinary disorders
Dysuria
|
0.63%
1/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.68%
1/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
1.1%
1/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.68%
1/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Renal and urinary disorders
Renal failure chronic
|
0.00%
0/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.68%
1/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Reproductive system and breast disorders
Priapism
|
0.63%
1/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Respiratory, thoracic and mediastinal disorders
Acute chest syndrome
|
1.9%
3/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
1.4%
2/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
1.1%
1/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.63%
1/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.68%
1/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
1.1%
1/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.00%
0/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.68%
1/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.68%
1/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Vascular disorders
Vascular occlusion
|
1.9%
3/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
1.4%
2/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
Other adverse events
| Measure |
13vPnC Dose 1
n=158 participants at risk
Participants previously immunized with 23vPS who received a single 0.5 mL dose of 13vPnC intramuscular injection on Day 1 (13vPnC Dose 1), assessed between 13vPnC Dose 1 and before 13vPnC Dose2.
|
13vPnC Dose 2
n=140 participants at risk
Participants previously immunized with 23vPS who received Dose 2 of 0.5 mL 13vPnC intramuscular injection, assessed between 13vPnC Dose 2 and before 13vPnC Dose 2 blood draw.
|
6-Month Follow-up
n=147 participants at risk
Participants previously immunized with 23vPS who received at least 1 of the 2 single 0.5 mL doses of 13vPnC intramuscular injection, 6 months apart, assessed from last 13vPnC Dose (Dose 1 or Dose 2) blood draw to the 6-month follow-up telephone contact.
|
1-Year Follow-up
n=87 participants at risk
Participants previously immunized with 23vPS who received 2 single 0.5 mL doses of 13vPnC intramuscular injection, 6 months apart, assessed from the 6-month follow-up telephone contact after 13vPnC Dose 2 to the 1-year follow-up after 13vPnC Dose 2.
|
|---|---|---|---|---|
|
Congenital, familial and genetic disorders
Sickle cell anaemia with crisis
|
2.5%
4/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.71%
1/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.71%
1/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Eye disorders
Conjunctivitis allergic
|
0.63%
1/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Eye disorders
Periorbital oedema
|
0.63%
1/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.71%
1/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Eye disorders
Ocular icterus
|
0.00%
0/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.71%
1/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Gastrointestinal disorders
Diarrhoea
|
1.3%
2/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Gastrointestinal disorders
Vomiting
|
1.3%
2/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.63%
1/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Gastrointestinal disorders
Constipation
|
0.63%
1/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Gastrointestinal disorders
Nausea
|
0.63%
1/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Gastrointestinal disorders
Pancreatic calcification
|
0.63%
1/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.71%
1/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.71%
1/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.71%
1/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
1.1%
1/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
General disorders
Pyrexia
|
3.2%
5/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.71%
1/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
General disorders
Chest pain
|
1.3%
2/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
General disorders
Injection site pain
|
0.63%
1/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
General disorders
Asthenia
|
0.63%
1/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
General disorders
Injection site erythema
|
0.63%
1/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
General disorders
Injection site movement impairment
|
0.63%
1/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
General disorders
Oedema peripheral
|
0.63%
1/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
General disorders
Swelling
|
0.63%
1/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Rhinitis
|
0.63%
1/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
General disorders
Injection site swelling
|
0.00%
0/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.71%
1/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
General disorders
Pain
|
0.00%
0/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.71%
1/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.3%
2/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Nasopharyngitis
|
1.3%
2/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Infection
|
0.63%
1/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Pharyngitis
|
0.63%
1/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.71%
1/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.63%
1/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
0.63%
1/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.63%
1/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.3%
2/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
1.4%
2/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.63%
1/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.71%
1/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.71%
1/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.71%
1/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
General disorders
Vomiting (Severe)
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
1.6%
1/64 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Nervous system disorders
Headache
|
2.5%
4/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.71%
1/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Nervous system disorders
Convulsion
|
0.63%
1/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Nervous system disorders
Hypoaesthesia
|
0.63%
1/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Nervous system disorders
Moyamoya disease
|
0.63%
1/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Psychiatric disorders
Depression
|
0.63%
1/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Psychiatric disorders
Insomnia
|
0.63%
1/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Psychiatric disorders
Listless
|
0.00%
0/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.71%
1/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Renal and urinary disorders
Renal failure chronic
|
0.63%
1/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.3%
2/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.3%
2/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.63%
1/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.63%
1/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.63%
1/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Reproductive system and breast disorders
Nasal congestion
|
0.63%
1/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.71%
1/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.68%
1/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.63%
1/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Vascular disorders
Vascular occlusion
|
2.5%
4/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Vascular disorders
Hypertension
|
0.63%
1/158 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/140 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/147 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Pain (Any)
|
89.6%
129/144 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
85.6%
95/111 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Pain (Mild)
|
81.8%
108/132 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
77.7%
80/103 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Pain (Moderate)
|
56.6%
64/113 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
53.7%
44/82 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Pain (Severe)
|
11.1%
10/90 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
15.9%
11/69 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Redness (Any)
|
23.7%
22/93 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
26.9%
18/67 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Redness (Mild)
|
20.4%
19/93 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
15.2%
10/66 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Redness (Moderate)
|
8.9%
8/90 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
14.1%
9/64 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Redness (Severe)
|
1.1%
1/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/63 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Swelling (Any)
|
49.1%
53/108 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
53.6%
45/84 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Swelling (Mild)
|
37.6%
38/101 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
37.7%
29/77 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Swelling (Moderate)
|
26.0%
26/100 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
35.6%
26/73 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Swelling (Severe)
|
1.1%
1/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
0.00%
0/63 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
General disorders
Fever >=38°C but =<38.4°C
|
13.6%
11/81 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
9.5%
6/63 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
General disorders
Fever >38.4°C but =<38.9°C
|
7.3%
6/82 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
6.8%
4/59 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
General disorders
Fever >38.9°C but =<40.0°C
|
3.8%
3/79 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
6.3%
4/63 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
General disorders
Fever >40.0°C
|
1.3%
1/79 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
1.7%
1/60 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
General disorders
Vomiting (Any)
|
15.4%
14/91 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
13.4%
9/67 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
General disorders
Vomiting (Mild)
|
11.2%
10/89 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
9.2%
6/65 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
General disorders
Vomiting (Moderate)
|
6.7%
6/90 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
4.7%
3/64 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
General disorders
Diarrhea (Any)
|
13.3%
12/90 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
25.0%
17/68 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
General disorders
Diarrhea (Mild)
|
6.9%
6/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
19.1%
13/68 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
General disorders
Diarrhea (Moderate)
|
6.7%
6/90 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
12.1%
8/66 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
General disorders
Diarrhea (Severe)
|
2.3%
2/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
3.2%
2/63 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
General disorders
Headache (Any)
|
53.6%
59/110 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
59.3%
51/86 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
General disorders
Headache (Mild)
|
42.9%
45/105 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
41.9%
31/74 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
General disorders
Headache (Moderate)
|
34.7%
35/101 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
36.8%
28/76 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
General disorders
Headache (Severe)
|
12.0%
11/92 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
10.6%
7/66 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
General disorders
Fatigue (Any)
|
66.1%
78/118 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
62.5%
60/96 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
General disorders
Fatigue (Mild)
|
48.1%
52/108 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
48.8%
41/84 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
General disorders
Fatigue (Moderate)
|
44.2%
46/104 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
41.0%
34/83 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
General disorders
Fatigue (Severe)
|
14.4%
13/90 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
13.4%
9/67 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
General disorders
Muscle pain (Any)
|
74.8%
95/127 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
75.5%
74/98 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
General disorders
Muscle pain (Mild)
|
58.8%
67/114 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
60.9%
53/87 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
General disorders
Muscle pain (Moderate)
|
47.2%
51/108 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
45.2%
38/84 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
General disorders
Muscle pain (Severe)
|
10.1%
9/89 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
16.4%
11/67 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
General disorders
Joint pain (Any)
|
39.8%
41/103 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
44.9%
35/78 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
General disorders
Joint pain (Mild)
|
23.5%
23/98 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
34.7%
25/72 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
General disorders
Joint pain (Moderate)
|
23.4%
22/94 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
21.4%
15/70 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
|
General disorders
Joint pain (Severe)
|
4.5%
4/89 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
6.2%
4/65 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
|
—
0/0 • SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic 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