Trial Outcomes & Findings for Study Evaluating a 13-valent Pneumococcal Conjugate Vaccine in Preterm Compared to Term Infants. (NCT NCT01193335)
NCT ID: NCT01193335
Last Updated: 2017-05-11
Results Overview
Percentage of participants achieving predefined antibody threshold \>=0.35 mcg/mL along with the corresponding 95 percent (%) confidence interval (CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. Exact 2-sided CI based on the observed proportion of participants. Here 'n' signifies participants with a determinate IgG concentration to the given serotype for each arm, respectively.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
200 participants
Primary outcome timeframe
1 month after the infant series
Results posted on
2017-05-11
Participant Flow
Participant milestones
| Measure |
13vPnC Group 1 (Preterm Infant)
Preterm infant participants (gestational age \[GA\] less than \[\<\] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to \[\>=\] 32 weeks and \<37 weeks), Group 1B (GA \>=29 weeks and \<32 weeks) and Group 1C (GA \<29 weeks).
|
13vPnC Group 2 (Term Infant)
Term infant participants (GA \>=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
|
|---|---|---|
|
Infant Series
STARTED
|
100
|
100
|
|
Infant Series
COMPLETED
|
100
|
100
|
|
Infant Series
NOT COMPLETED
|
0
|
0
|
|
After Infant Series
STARTED
|
100
|
100
|
|
After Infant Series
COMPLETED
|
99
|
97
|
|
After Infant Series
NOT COMPLETED
|
1
|
3
|
|
Toddler Dose
STARTED
|
99
|
97
|
|
Toddler Dose
COMPLETED
|
99
|
97
|
|
Toddler Dose
NOT COMPLETED
|
0
|
0
|
|
1-Year Follow-up
STARTED
|
99
|
97
|
|
1-Year Follow-up
COMPLETED
|
88
|
88
|
|
1-Year Follow-up
NOT COMPLETED
|
11
|
9
|
|
2-Year Follow-up
STARTED
|
88
|
88
|
|
2-Year Follow-up
COMPLETED
|
81
|
80
|
|
2-Year Follow-up
NOT COMPLETED
|
7
|
8
|
Reasons for withdrawal
| Measure |
13vPnC Group 1 (Preterm Infant)
Preterm infant participants (gestational age \[GA\] less than \[\<\] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to \[\>=\] 32 weeks and \<37 weeks), Group 1B (GA \>=29 weeks and \<32 weeks) and Group 1C (GA \<29 weeks).
|
13vPnC Group 2 (Term Infant)
Term infant participants (GA \>=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
|
|---|---|---|
|
After Infant Series
Lost to Follow-up
|
1
|
2
|
|
After Infant Series
No Longer Met Eligibility Criteria
|
0
|
1
|
|
1-Year Follow-up
No Longer Willing to Participate
|
7
|
9
|
|
1-Year Follow-up
Lost to Follow-up
|
4
|
0
|
|
2-Year Follow-up
No Longer Willing to Participate
|
5
|
6
|
|
2-Year Follow-up
No Longer Met Eligibility Criteria
|
2
|
2
|
Baseline Characteristics
Study Evaluating a 13-valent Pneumococcal Conjugate Vaccine in Preterm Compared to Term Infants.
Baseline characteristics by cohort
| Measure |
13vPnC Group 1 (Preterm Infant)
n=100 Participants
Preterm infant participants (gestational age \[GA\] less than \[\<\] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to \[\>=\] 32 weeks and \<37 weeks), Group 1B (GA \>=29 weeks and \<32 weeks) and Group 1C (GA \<29 weeks).
|
13vPnC Group 2 (Term Infant)
n=100 Participants
Term infant participants (GA \>=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
|
Total
n=200 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
1.8 months
STANDARD_DEVIATION 0.6 • n=93 Participants
|
1.5 months
STANDARD_DEVIATION 0.5 • n=4 Participants
|
1.7 months
STANDARD_DEVIATION 0.6 • n=27 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=93 Participants
|
55 Participants
n=4 Participants
|
103 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=93 Participants
|
45 Participants
n=4 Participants
|
97 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 1 month after the infant seriesPopulation: Evaluable infant immunogenicity population included eligible participants who received all the assigned vaccinations (Infant Dose 1, 2 and 3), had blood drawn within required time frames, had at least 1 valid and determinate assay result for the proposed analysis, received no prohibited vaccines, and had no major protocol violations.
Percentage of participants achieving predefined antibody threshold \>=0.35 mcg/mL along with the corresponding 95 percent (%) confidence interval (CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. Exact 2-sided CI based on the observed proportion of participants. Here 'n' signifies participants with a determinate IgG concentration to the given serotype for each arm, respectively.
Outcome measures
| Measure |
13vPnC Group 1 (Preterm Infant)
n=99 Participants
Preterm infant participants (gestational age \[GA\] less than \[\<\] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to \[\>=\] 32 weeks and \<37 weeks), Group 1B (GA \>=29 weeks and \<32 weeks) and Group 1C (GA \<29 weeks).
|
13vPnC Group 2 (Term Infant)
n=98 Participants
Term infant participants (GA \>=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
|
13vPnC Group 1C
Preterm participants with GA \<29 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
|
|---|---|---|---|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After Infant Series
9V (n=99, 97)
|
96.97 percentage of participants
Interval 91.4 to 99.37
|
96.91 percentage of participants
Interval 91.23 to 99.36
|
—
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After Infant Series
19F (n=99, 97)
|
98.99 percentage of participants
Interval 94.5 to 99.97
|
98.97 percentage of participants
Interval 94.39 to 99.97
|
—
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After Infant Series
3 (n=99, 97)
|
85.86 percentage of participants
Interval 77.41 to 92.05
|
90.72 percentage of participants
Interval 83.12 to 95.67
|
—
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After Infant Series
19A (n=99, 97)
|
98.99 percentage of participants
Interval 94.5 to 99.97
|
98.97 percentage of participants
Interval 94.39 to 99.97
|
—
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After Infant Series
4 (n=99, 97)
|
96.97 percentage of participants
Interval 91.4 to 99.37
|
98.97 percentage of participants
Interval 94.39 to 99.97
|
—
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After Infant Series
6B (n=99, 97)
|
72.73 percentage of participants
Interval 62.85 to 81.2
|
87.63 percentage of participants
Interval 79.39 to 93.44
|
—
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After Infant Series
14 (n=99, 97)
|
100.00 percentage of participants
Interval 96.34 to 100.0
|
97.94 percentage of participants
Interval 92.75 to 99.75
|
—
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After Infant Series
18C (n=99, 97)
|
96.97 percentage of participants
Interval 91.4 to 99.37
|
94.85 percentage of participants
Interval 88.38 to 98.31
|
—
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After Infant Series
23F (n=99, 97 )
|
85.86 percentage of participants
Interval 77.41 to 92.05
|
92.78 percentage of participants
Interval 85.7 to 97.05
|
—
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After Infant Series
1 (n=99, 97)
|
93.94 percentage of participants
Interval 87.27 to 97.74
|
95.88 percentage of participants
Interval 89.78 to 98.87
|
—
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After Infant Series
5 (n=99, 97)
|
71.72 percentage of participants
Interval 61.78 to 80.31
|
90.72 percentage of participants
Interval 83.12 to 95.67
|
—
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After Infant Series
6A (n=98, 97)
|
82.65 percentage of participants
Interval 73.69 to 89.56
|
94.85 percentage of participants
Interval 88.38 to 98.31
|
—
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After Infant Series
7F (n=99, 97)
|
98.99 percentage of participants
Interval 94.5 to 99.97
|
98.97 percentage of participants
Interval 94.39 to 99.97
|
—
|
PRIMARY outcome
Timeframe: 1 month after the infant seriesPopulation: Evaluable infant immunogenicity population. Here 'n' signifies participants with a determinate IgG concentration to the given serotype for each arm, respectively.
Antibody geometric mean concentration (GMC) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMCs were calculated using all participants with available data for the specified blood draw. CIs for GMC were back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Outcome measures
| Measure |
13vPnC Group 1 (Preterm Infant)
n=99 Participants
Preterm infant participants (gestational age \[GA\] less than \[\<\] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to \[\>=\] 32 weeks and \<37 weeks), Group 1B (GA \>=29 weeks and \<32 weeks) and Group 1C (GA \<29 weeks).
|
13vPnC Group 2 (Term Infant)
n=98 Participants
Term infant participants (GA \>=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
|
13vPnC Group 1C
Preterm participants with GA \<29 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
|
|---|---|---|---|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series
9V (n=99, 97)
|
1.26 mcg/mL
Interval 1.08 to 1.47
|
1.70 mcg/mL
Interval 1.45 to 2.0
|
—
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series
14 (n=99, 97)
|
7.48 mcg/mL
Interval 6.23 to 8.99
|
6.08 mcg/mL
Interval 4.82 to 7.67
|
—
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series
7F (n=99, 97)
|
2.14 mcg/mL
Interval 1.81 to 2.53
|
3.02 mcg/mL
Interval 2.63 to 3.48
|
—
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series
5 (n=99, 97)
|
0.56 mcg/mL
Interval 0.44 to 0.7
|
1.03 mcg/mL
Interval 0.87 to 1.22
|
—
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series
6A (n=98, 97)
|
1.22 mcg/mL
Interval 0.98 to 1.53
|
2.01 mcg/mL
Interval 1.65 to 2.46
|
—
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series
4 (n=99, 97)
|
1.96 mcg/mL
Interval 1.67 to 2.31
|
2.46 mcg/mL
Interval 2.04 to 2.97
|
—
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series
6B (n=99, 97)
|
0.73 mcg/mL
Interval 0.55 to 0.97
|
1.30 mcg/mL
Interval 1.0 to 1.67
|
—
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series
18C (n=99, 97)
|
1.93 mcg/mL
Interval 1.66 to 2.24
|
1.93 mcg/mL
Interval 1.62 to 2.29
|
—
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series
19F (n=99, 97)
|
2.21 mcg/mL
Interval 1.89 to 2.58
|
3.05 mcg/mL
Interval 2.62 to 3.55
|
—
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series
23F (n=99, 97)
|
0.86 mcg/mL
Interval 0.69 to 1.07
|
1.36 mcg/mL
Interval 1.1 to 1.68
|
—
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series
1 (n=99, 97)
|
1.26 mcg/mL
Interval 1.06 to 1.48
|
1.79 mcg/mL
Interval 1.5 to 2.13
|
—
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series
3 (n=99, 97)
|
0.83 mcg/mL
Interval 0.7 to 0.98
|
0.86 mcg/mL
Interval 0.75 to 1.0
|
—
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series
19A (n=99, 97)
|
2.85 mcg/mL
Interval 2.44 to 3.33
|
3.35 mcg/mL
Interval 2.85 to 3.94
|
—
|
PRIMARY outcome
Timeframe: Within 7 days after Dose 1 of the infant seriesPopulation: Safety population for Dose 1 infant series: all participants who received13vPnC Dose 1. Here 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction.'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Mild (hurts if gently touched with no crying); Moderate (hurts if gently touched with crying); Severe (causes limitation of limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters \[cm\] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (\>7.0 cm). Participants may be represented in more than 1 category.
Outcome measures
| Measure |
13vPnC Group 1 (Preterm Infant)
n=98 Participants
Preterm infant participants (gestational age \[GA\] less than \[\<\] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to \[\>=\] 32 weeks and \<37 weeks), Group 1B (GA \>=29 weeks and \<32 weeks) and Group 1C (GA \<29 weeks).
|
13vPnC Group 2 (Term Infant)
n=92 Participants
Term infant participants (GA \>=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
|
13vPnC Group 1C
Preterm participants with GA \<29 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
|
|---|---|---|---|
|
Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 1 Infant Series
Tenderness- Moderate (n=90, 85)
|
17.8 percentage of participants
|
16.5 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 1 Infant Series
Swelling- Any (n=94, 89)
|
39.4 percentage of participants
|
29.2 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 1 Infant Series
Tenderness- Any (n=94, 88)
|
48.9 percentage of participants
|
42.0 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 1 Infant Series
Tenderness- Mild (n=93, 88)
|
46.2 percentage of participants
|
31.8 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 1 Infant Series
Tenderness- Severe (n=86, 85)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 1 Infant Series
Swelling- Mild (n=91, 89)
|
37.4 percentage of participants
|
28.1 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 1 Infant Series
Swelling- Moderate (n=91, 85)
|
8.8 percentage of participants
|
8.2 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 1 Infant Series
Swelling- Severe (n=86, 85)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 1 Infant Series
Redness- Any (n=92, 87)
|
33.7 percentage of participants
|
29.9 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 1 Infant Series
Redness- Mild (n=90, 87)
|
32.2 percentage of participants
|
28.7 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 1 Infant Series
Redness- Moderate (n=88, 85)
|
3.4 percentage of participants
|
4.7 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 1 Infant Series
Redness- Severe (n=86, 85)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
—
|
PRIMARY outcome
Timeframe: Within 7 days after Dose 2 of the infant seriesPopulation: Safety population for Dose 2 infant series: all participants who received 13vPnC Dose 2.Here 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction.'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Mild (hurts if gently touched with no crying); Moderate (hurts if gently touched with crying); Severe (causes limitation of limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters \[cm\] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (\>7.0 cm). Participants may be represented in more than 1 category.
Outcome measures
| Measure |
13vPnC Group 1 (Preterm Infant)
n=89 Participants
Preterm infant participants (gestational age \[GA\] less than \[\<\] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to \[\>=\] 32 weeks and \<37 weeks), Group 1B (GA \>=29 weeks and \<32 weeks) and Group 1C (GA \<29 weeks).
|
13vPnC Group 2 (Term Infant)
n=89 Participants
Term infant participants (GA \>=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
|
13vPnC Group 1C
Preterm participants with GA \<29 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
|
|---|---|---|---|
|
Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 2 Infant Series
Swelling- Any (n=84, 82)
|
35.7 percentage of participants
|
42.7 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 2 Infant Series
Redness- Mild (n=82, 82)
|
28.0 percentage of participants
|
37.8 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 2 Infant Series
Tenderness- Any (n=85, 88 )
|
48.2 percentage of participants
|
38.6 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 2 Infant Series
Tenderness- Mild (n=85, 84)
|
43.5 percentage of participants
|
31.0 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 2 Infant Series
Tenderness- Moderate (n=77, 83)
|
14.3 percentage of participants
|
15.7 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 2 Infant Series
Tenderness- Severe (n=73, 77)
|
0.0 percentage of participants
|
1.3 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 2 Infant Series
Swelling- Mild (n=83, 82)
|
33.7 percentage of participants
|
42.7 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 2 Infant Series
Swelling- Moderate (n=75, 76)
|
8.0 percentage of participants
|
2.6 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 2 Infant Series
Swelling- Severe (n=73, 76)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 2 Infant Series
Redness- Any (n=82, 82)
|
28.0 percentage of participants
|
40.2 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 2 Infant Series
Redness- Moderate (n=73, 76)
|
2.7 percentage of participants
|
2.6 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 2 Infant Series
Redness- Severe (n=73, 76)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
—
|
PRIMARY outcome
Timeframe: Within 7 days after Dose 3 of the infant seriesPopulation: Safety population for Dose 3 infant series: all participants who received 13vPnC Dose 3.Here 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction.'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Mild (hurts if gently touched with no crying); Moderate (hurts if gently touched with crying); Severe (causes limitation of limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters \[cm\] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (\>7.0 cm). Participants may be represented in more than 1 category.
Outcome measures
| Measure |
13vPnC Group 1 (Preterm Infant)
n=87 Participants
Preterm infant participants (gestational age \[GA\] less than \[\<\] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to \[\>=\] 32 weeks and \<37 weeks), Group 1B (GA \>=29 weeks and \<32 weeks) and Group 1C (GA \<29 weeks).
|
13vPnC Group 2 (Term Infant)
n=90 Participants
Term infant participants (GA \>=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
|
13vPnC Group 1C
Preterm participants with GA \<29 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
|
|---|---|---|---|
|
Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 3 Infant Series
Swelling- Any (n=83, 85)
|
30.1 percentage of participants
|
41.2 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 3 Infant Series
Swelling- Mild (n=82, 85)
|
26.8 percentage of participants
|
41.2 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 3 Infant Series
Redness- Any (n=82, 87)
|
32.9 percentage of participants
|
46.0 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 3 Infant Series
Redness- Mild (n=82, 87)
|
32.9 percentage of participants
|
46.0 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 3 Infant Series
Tenderness- Any (n=82, 84)
|
39.0 percentage of participants
|
28.6 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 3 Infant Series
Tenderness- Mild (n=81, 84)
|
35.8 percentage of participants
|
26.2 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 3 Infant Series
Tenderness- Moderate (n=75, 78)
|
9.3 percentage of participants
|
5.1 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 3 Infant Series
Tenderness- Severe (n=73, 77)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 3 Infant Series
Swelling- Moderate (n=75, 79)
|
5.3 percentage of participants
|
5.1 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 3 Infant Series
Swelling- Severe (n=73, 77)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 3 Infant Series
Redness- Moderate (n=74, 79)
|
1.4 percentage of participants
|
3.8 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 3 Infant Series
Redness- Severe (n=73, 77)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
—
|
PRIMARY outcome
Timeframe: Within 7 days after the toddler dosePopulation: Safety population for Toddler Dose: all participants who received 13vPnC Toddler Dose. Here 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction.'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Mild (hurts if gently touched with no crying); Moderate (hurts if gently touched with crying); Severe (causes limitation of limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters \[cm\] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (\>7.0 cm). Participants may be represented in more than 1 category.
Outcome measures
| Measure |
13vPnC Group 1 (Preterm Infant)
n=89 Participants
Preterm infant participants (gestational age \[GA\] less than \[\<\] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to \[\>=\] 32 weeks and \<37 weeks), Group 1B (GA \>=29 weeks and \<32 weeks) and Group 1C (GA \<29 weeks).
|
13vPnC Group 2 (Term Infant)
n=88 Participants
Term infant participants (GA \>=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
|
13vPnC Group 1C
Preterm participants with GA \<29 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
|
|---|---|---|---|
|
Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Toddler Dose
Tenderness- Any (n=86, 85)
|
69.8 percentage of participants
|
55.3 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Toddler Dose
Tenderness- Mild (n=86, 85)
|
66.3 percentage of participants
|
51.8 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Toddler Dose
Tenderness- Moderate (n=77, 70)
|
20.8 percentage of participants
|
11.4 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Toddler Dose
Tenderness- Severe (n=74, 69)
|
2.7 percentage of participants
|
0.0 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Toddler Dose
Swelling- Any (n=81, 80)
|
43.2 percentage of participants
|
35.0 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Toddler Dose
Swelling- Mild (n=80, 79)
|
38.8 percentage of participants
|
32.9 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Toddler Dose
Swelling- Moderate (n=76, 74)
|
13.2 percentage of participants
|
9.5 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Toddler Dose
Swelling- Severe (n=74, 69)
|
1.4 percentage of participants
|
0.0 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Toddler Dose
Redness- Any (n=85, 83)
|
51.8 percentage of participants
|
49.4 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Toddler Dose
Redness- Mild (n=85, 83)
|
51.8 percentage of participants
|
48.2 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Toddler Dose
Redness- Moderate (n=75, 75)
|
6.7 percentage of participants
|
10.7 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Toddler Dose
Redness- Severe (n=74, 69)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
—
|
PRIMARY outcome
Timeframe: Within 7 days after Dose 1 of the infant seriesPopulation: Safety population for Dose 1 infant series: all participants who received 13vPnC Dose 1. Here 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any event and 'n'=participants reporting yes for at least 1 day or no for all days for specified event for each group, respectively.
Systemic events (fever \>=38 degrees Celsius \[C\], decreased appetite, increased sleep, and irritability or decreased sleep) and use of antipyretic medication were reported using an electronic diary. Decreased appetite was scaled as Any; Mild (loss of appetite but no decreased oral intake); Moderate (decreased oral intake); Severe (refusal to feed). Increased sleep was scaled as Any; Mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (disabling not interested in usual daily activity). Irritability or decreased sleep was scaled as Any; Mild (easily consolable); Moderate (requiring increased attention); Severe (inconsolable; crying that cannot be comforted). Participants may be represented in more than 1 category.
Outcome measures
| Measure |
13vPnC Group 1 (Preterm Infant)
n=98 Participants
Preterm infant participants (gestational age \[GA\] less than \[\<\] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to \[\>=\] 32 weeks and \<37 weeks), Group 1B (GA \>=29 weeks and \<32 weeks) and Group 1C (GA \<29 weeks).
|
13vPnC Group 2 (Term Infant)
n=99 Participants
Term infant participants (GA \>=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
|
13vPnC Group 1C
Preterm participants with GA \<29 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
|
|---|---|---|---|
|
Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 1 Infant Series
Irritability or Decreased Sleep- Mild (n=93, 95)
|
77.4 percentage of participants
|
69.5 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 1 Infant Series
Fever >=38 degrees C (n=86, 88)
|
11.6 percentage of participants
|
13.6 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 1 Infant Series
Fever >=38 degrees C, =<39 degrees C (n=86, 88)
|
10.5 percentage of participants
|
13.6 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 1 Infant Series
Fever >=39 degrees C, =<40 degrees C (n=86, 85)
|
1.2 percentage of participants
|
0.0 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 1 Infant Series
Fever >40 degrees C (n=86, 85)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 1 Infant Series
Decreased Appetite- Any (n=92, 89)
|
60.9 percentage of participants
|
41.6 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 1 Infant Series
Decreased Appetite- Mild (n=91, 88)
|
54.9 percentage of participants
|
35.2 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 1 Infant Series
Decreased Appetite- Moderate (n=88, 87)
|
20.5 percentage of participants
|
17.2 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 1 Infant Series
Decreased Appetite- Severe (n=86, 85)
|
1.2 percentage of participants
|
0.0 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 1 Infant Series
Increased Sleep- Any (n=96, 95)
|
67.7 percentage of participants
|
69.5 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 1 Infant Series
Increased Sleep- Mild (n=96, 93)
|
60.4 percentage of participants
|
61.3 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 1 Infant Series
Increased Sleep- Moderate (n=87, 88)
|
29.9 percentage of participants
|
30.7 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 1 Infant Series
Increased Sleep- Severe (n=86, 85)
|
2.3 percentage of participants
|
2.4 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 1 Infant Series
Irritability or Decreased Sleep- Any (n=95, 97)
|
84.2 percentage of participants
|
82.5 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 1 Infant Series
Irritability or Decreased Sleep-Moderate (n=92, 91
|
43.5 percentage of participants
|
47.3 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 1 Infant Series
Irritability or Decreased Sleep- Severe (n=86, 85)
|
8.1 percentage of participants
|
5.9 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 1 Infant Series
Use of Antipyretic Medication (n=90, 90)
|
24.4 percentage of participants
|
24.4 percentage of participants
|
—
|
PRIMARY outcome
Timeframe: Within 7 days after Dose 2 of the infant seriesPopulation: Safety population for Dose 2 infant series: all participants who received 13vPnC Dose 2. Here 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any event and 'n'=participants reporting yes for at least 1 day or no for all days for specified event for each group, respectively.
Systemic events (fever \>=38 degrees Celsius \[C\], decreased appetite, increased sleep, and irritability or decreased sleep) and use of antipyretic medication were reported using an electronic diary. Decreased appetite was scaled as Any; Mild (loss of appetite but no decreased oral intake); Moderate (decreased oral intake); Severe (refusal to feed). Increased sleep was scaled as Any; Mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (disabling not interested in usual daily activity). Irritability or decreased sleep was scaled as Any; Mild (easily consolable); Moderate (requiring increased attention); Severe (inconsolable; crying that cannot be comforted). Participants may be represented in more than 1 category.
Outcome measures
| Measure |
13vPnC Group 1 (Preterm Infant)
n=97 Participants
Preterm infant participants (gestational age \[GA\] less than \[\<\] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to \[\>=\] 32 weeks and \<37 weeks), Group 1B (GA \>=29 weeks and \<32 weeks) and Group 1C (GA \<29 weeks).
|
13vPnC Group 2 (Term Infant)
n=96 Participants
Term infant participants (GA \>=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
|
13vPnC Group 1C
Preterm participants with GA \<29 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
|
|---|---|---|---|
|
Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 2 Infant Series
Fever >=38 degrees C (n=79, 79)
|
27.8 percentage of participants
|
31.6 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 2 Infant Series
Fever >=38 degrees C, =<39 degrees C (n=79, 79)
|
27.8 percentage of participants
|
30.4 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 2 Infant Series
Fever >=39 degrees C, =<40 degrees C (n=73, 76)
|
0.0 percentage of participants
|
1.3 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 2 Infant Series
Fever >40 degrees C (n=73, 76)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 2 Infant Series
Decreased Appetite- Any (n=89, 84)
|
61.8 percentage of participants
|
46.4 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 2 Infant Series
Decreased Appetite- Mild (n=88, 84)
|
55.7 percentage of participants
|
41.7 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 2 Infant Series
Decreased Appetite- Moderate (n=79, 78)
|
25.3 percentage of participants
|
19.2 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 2 Infant Series
Decreased Appetite- Severe (n=73, 76)
|
1.4 percentage of participants
|
0.0 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 2 Infant Series
Increased Sleep- Any (n=85, 89 )
|
74.1 percentage of participants
|
64.0 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 2 Infant Series
Increased Sleep- Mild (n=83, 88)
|
69.9 percentage of participants
|
59.1 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 2 Infant Series
Increased Sleep- Moderate (n=78, 78)
|
34.6 percentage of participants
|
29.5 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 2 Infant Series
Increased Sleep- Severe (n=73, 76)
|
2.7 percentage of participants
|
1.3 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 2 Infant Series
Irritability or Decreased Sleep- Any (n=95, 95)
|
89.5 percentage of participants
|
77.9 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 2 Infant Series
Irritability or Decreased Sleep- Mild (n=90, 92)
|
81.1 percentage of participants
|
71.7 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 2 Infant Series
Irritability or Decreased Sleep-Moderate (n=85, 86
|
64.7 percentage of participants
|
44.2 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 2 Infant Series
Irritability or Decreased Sleep- Severe (n=74, 76)
|
17.6 percentage of participants
|
2.6 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 2 Infant Series
Use of Antipyretic Medication (n=84, 83)
|
48.8 percentage of participants
|
45.8 percentage of participants
|
—
|
PRIMARY outcome
Timeframe: Within 7 days after Dose 3 of the infant seriesPopulation: Safety population for Dose 3 infant series: all participants who received 13vPnC Dose 3. Here 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any event and 'n'=participants reporting yes for at least 1 day or no for all days for specified event for each group, respectively.
Systemic events (fever \>=38 degrees Celsius \[C\], decreased appetite, increased sleep, and irritability or decreased sleep) and use of antipyretic medication were reported using an electronic diary. Decreased appetite was scaled as Any; Mild (loss of appetite but no decreased oral intake); Moderate (decreased oral intake); Severe (refusal to feed). Increased sleep was scaled as Any; Mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (disabling not interested in usual daily activity). Irritability or decreased sleep was scaled as Any; Mild (easily consolable); Moderate (requiring increased attention); Severe (inconsolable; crying that cannot be comforted). Participants may be represented in more than 1 category.
Outcome measures
| Measure |
13vPnC Group 1 (Preterm Infant)
n=94 Participants
Preterm infant participants (gestational age \[GA\] less than \[\<\] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to \[\>=\] 32 weeks and \<37 weeks), Group 1B (GA \>=29 weeks and \<32 weeks) and Group 1C (GA \<29 weeks).
|
13vPnC Group 2 (Term Infant)
n=95 Participants
Term infant participants (GA \>=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
|
13vPnC Group 1C
Preterm participants with GA \<29 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
|
|---|---|---|---|
|
Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 3 Infant Series
Fever >=38 degrees C (n=79, 81)
|
27.8 percentage of participants
|
30.9 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 3 Infant Series
Increased Sleep- Severe (n=73, 77)
|
1.4 percentage of participants
|
1.3 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 3 Infant Series
Fever >=38 degrees C, =<39 degrees C (n=78, 81)
|
26.9 percentage of participants
|
30.9 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 3 Infant Series
Fever >=39 degrees C, =<40 degrees C (n=75, 78)
|
1.3 percentage of participants
|
2.6 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 3 Infant Series
Fever >40 degrees C (n=74, 77)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 3 Infant Series
Decreased Appetite- Any (n=82, 84)
|
48.8 percentage of participants
|
47.6 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 3 Infant Series
Decreased Appetite- Mild (n=82, 84)
|
36.6 percentage of participants
|
46.4 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 3 Infant Series
Decreased Appetite- Moderate (n=74, 79)
|
17.6 percentage of participants
|
16.5 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 3 Infant Series
Decreased Appetite- Severe (n=74, 77)
|
1.4 percentage of participants
|
1.3 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 3 Infant Series
Increased Sleep- Any (n=88, 88 )
|
52.3 percentage of participants
|
58.0 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 3 Infant Series
Increased Sleep- Mild (n=88, 87)
|
48.9 percentage of participants
|
51.7 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 3 Infant Series
Increased Sleep- Moderate (n=77, 80)
|
16.9 percentage of participants
|
20.0 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 3 Infant Series
Irritability or Decreased Sleep- Any (n=92, 95)
|
79.3 percentage of participants
|
81.1 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 3 Infant Series
Irritability or Decreased Sleep- Mild (n=90, 91)
|
72.2 percentage of participants
|
74.7 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 3 Infant Series
Irritability or Decreased Sleep-Moderate (n=80,87)
|
33.8 percentage of participants
|
35.6 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 3 Infant Series
Irritability or Decreased Sleep- Severe (n=74, 78)
|
6.8 percentage of participants
|
6.4 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 3 Infant Series
Use of Antipyretic Medication (n=84, 81)
|
40.5 percentage of participants
|
38.3 percentage of participants
|
—
|
PRIMARY outcome
Timeframe: Within 7 days after the toddler dosePopulation: Safety population for Toddler Dose: all participants who received 13vPnC Toddler Dose. Here 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any event and 'n'=participants reporting yes for at least 1 day or no for all days for specified event for each group, respectively.
Systemic events (fever \>=38 degrees Celsius \[C\], decreased appetite, increased sleep, and irritability or decreased sleep) and use of antipyretic medication were reported using an electronic diary. Decreased appetite was scaled as Any; Mild (loss of appetite but no decreased oral intake); Moderate (decreased oral intake); Severe (refusal to feed). Increased sleep was scaled as Any; Mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (disabling not interested in usual daily activity). Irritability or decreased sleep was scaled as Any; Mild (easily consolable); Moderate (requiring increased attention); Severe (inconsolable; crying that cannot be comforted). Participants may be represented in more than 1 category.
Outcome measures
| Measure |
13vPnC Group 1 (Preterm Infant)
n=93 Participants
Preterm infant participants (gestational age \[GA\] less than \[\<\] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to \[\>=\] 32 weeks and \<37 weeks), Group 1B (GA \>=29 weeks and \<32 weeks) and Group 1C (GA \<29 weeks).
|
13vPnC Group 2 (Term Infant)
n=92 Participants
Term infant participants (GA \>=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
|
13vPnC Group 1C
Preterm participants with GA \<29 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
|
|---|---|---|---|
|
Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Toddler Dose
Fever >=38 degrees C (n= 80, 78)
|
28.8 percentage of participants
|
43.6 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Toddler Dose
Decreased Appetite- Moderate (n=78, 73)
|
25.6 percentage of participants
|
23.3 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Toddler Dose
Fever >=38 degrees C, =<39 degrees C (n=80, 77)
|
27.5 percentage of participants
|
42.9 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Toddler Dose
Fever >=39 degrees C, =<40 degrees C (n=74, 71)
|
1.4 percentage of participants
|
4.2 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Toddler Dose
Fever >40 degrees C (n=74, 70)
|
0.0 percentage of participants
|
1.4 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Toddler Dose
Decreased Appetite- Any (n=87, 86)
|
57.5 percentage of participants
|
60.5 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Toddler Dose
Decreased Appetite- Mild (n=86, 84)
|
50.0 percentage of participants
|
56.0 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Toddler Dose
Decreased Appetite- Severe (n=75, 69)
|
1.3 percentage of participants
|
1.4 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Toddler Dose
Increased Sleep- Any (n=83, 86 )
|
57.8 percentage of participants
|
65.1 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Toddler Dose
Increased Sleep- Mild (n=82, 84)
|
53.7 percentage of participants
|
59.5 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Toddler Dose
Increased Sleep- Moderate (n=76, 74)
|
18.4 percentage of participants
|
24.3 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Toddler Dose
Increased Sleep- Severe (n=74, 70)
|
0.0 percentage of participants
|
2.9 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Toddler Dose
Irritability or Decreased Sleep- Any (n=90, 91)
|
84.4 percentage of participants
|
80.2 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Toddler Dose
Irritability or Decreased Sleep- Mild (n=90, 89)
|
74.4 percentage of participants
|
76.4 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Toddler Dose
Irritability or Decreased Sleep-Moderate (n=78,80)
|
44.9 percentage of participants
|
45.0 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Toddler Dose
Irritability or Decreased Sleep- Severe (n=76, 69)
|
6.6 percentage of participants
|
4.3 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Toddler Dose
Use of Antipyretic Medication (n=82, 79)
|
48.8 percentage of participants
|
50.6 percentage of participants
|
—
|
PRIMARY outcome
Timeframe: Dose 1 up to 1 month after Dose 3 (infant series)Population: Safety population for infant series included all participants who received at least 1 dose of 13vPnC during infant series.
An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Outcome measures
| Measure |
13vPnC Group 1 (Preterm Infant)
n=100 Participants
Preterm infant participants (gestational age \[GA\] less than \[\<\] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to \[\>=\] 32 weeks and \<37 weeks), Group 1B (GA \>=29 weeks and \<32 weeks) and Group 1C (GA \<29 weeks).
|
13vPnC Group 2 (Term Infant)
n=100 Participants
Term infant participants (GA \>=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
|
13vPnC Group 1C
Preterm participants with GA \<29 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
|
|---|---|---|---|
|
Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs): Infant Series
AEs
|
59.0 percentage of participants
|
55.0 percentage of participants
|
—
|
|
Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs): Infant Series
SAEs
|
14.0 percentage of participants
|
5.0 percentage of participants
|
—
|
PRIMARY outcome
Timeframe: 1 Month after Dose 3 of the infant series up to toddler dosePopulation: Safety population for infant series included all participants who received at least 1 dose of 13vPnC during infant series.
An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Outcome measures
| Measure |
13vPnC Group 1 (Preterm Infant)
n=100 Participants
Preterm infant participants (gestational age \[GA\] less than \[\<\] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to \[\>=\] 32 weeks and \<37 weeks), Group 1B (GA \>=29 weeks and \<32 weeks) and Group 1C (GA \<29 weeks).
|
13vPnC Group 2 (Term Infant)
n=100 Participants
Term infant participants (GA \>=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
|
13vPnC Group 1C
Preterm participants with GA \<29 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
|
|---|---|---|---|
|
Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs): After Infant Series
SAEs
|
8.0 percentage of participants
|
9.0 percentage of participants
|
—
|
|
Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs): After Infant Series
AEs
|
18.0 percentage of participants
|
15.0 percentage of participants
|
—
|
PRIMARY outcome
Timeframe: Toddler dose up to 1 Month after toddler dosePopulation: Safety population for toddler dose included all participants who received 13vPnC toddler dose.
An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Outcome measures
| Measure |
13vPnC Group 1 (Preterm Infant)
n=99 Participants
Preterm infant participants (gestational age \[GA\] less than \[\<\] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to \[\>=\] 32 weeks and \<37 weeks), Group 1B (GA \>=29 weeks and \<32 weeks) and Group 1C (GA \<29 weeks).
|
13vPnC Group 2 (Term Infant)
n=97 Participants
Term infant participants (GA \>=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
|
13vPnC Group 1C
Preterm participants with GA \<29 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
|
|---|---|---|---|
|
Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs): Toddler Dose
AEs
|
31.3 percentage of participants
|
26.8 percentage of participants
|
—
|
|
Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs): Toddler Dose
SAEs
|
2.0 percentage of participants
|
1.0 percentage of participants
|
—
|
PRIMARY outcome
Timeframe: 1 month after toddler dose up to 1-year follow-upPopulation: Safety population for 1-year follow-up after toddler dose included all participants who received 13vPnC toddler dose and had safety data available during specified follow-up period.
An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Outcome measures
| Measure |
13vPnC Group 1 (Preterm Infant)
n=99 Participants
Preterm infant participants (gestational age \[GA\] less than \[\<\] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to \[\>=\] 32 weeks and \<37 weeks), Group 1B (GA \>=29 weeks and \<32 weeks) and Group 1C (GA \<29 weeks).
|
13vPnC Group 2 (Term Infant)
n=97 Participants
Term infant participants (GA \>=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
|
13vPnC Group 1C
Preterm participants with GA \<29 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
|
|---|---|---|---|
|
Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs): 1-Year Follow-up After Toddler Dose
AEs
|
15.2 percentage of participants
|
8.2 percentage of participants
|
—
|
|
Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs): 1-Year Follow-up After Toddler Dose
SAEs
|
13.1 percentage of participants
|
8.2 percentage of participants
|
—
|
PRIMARY outcome
Timeframe: 1-year follow-up after toddler dose to 2-year follow-up after toddler dosePopulation: Safety population for 2-year follow-up after toddler dose included all participants who received 13vPnC toddler dose and had safety data available during specified follow-up period.
An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Outcome measures
| Measure |
13vPnC Group 1 (Preterm Infant)
n=88 Participants
Preterm infant participants (gestational age \[GA\] less than \[\<\] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to \[\>=\] 32 weeks and \<37 weeks), Group 1B (GA \>=29 weeks and \<32 weeks) and Group 1C (GA \<29 weeks).
|
13vPnC Group 2 (Term Infant)
n=88 Participants
Term infant participants (GA \>=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
|
13vPnC Group 1C
Preterm participants with GA \<29 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
|
|---|---|---|---|
|
Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs): 2-Year Follow-up After Toddler Dose
SAEs
|
6.8 percentage of participants
|
9.1 percentage of participants
|
—
|
|
Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs): 2-Year Follow-up After Toddler Dose
AEs
|
8.0 percentage of participants
|
10.2 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Before 13vPnC Toddler Dose (pre-vaccination), 1 month after 13vPnC Toddler DosePopulation: Evaluable Toddler Immunogenicity Population. Here 'n' signifies participants with a determinate IgG antibody concentration to the given serotype for each arm, respectively.
GMFR for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) from before 13vPnC toddler dose to 1 month after 13vPnC toddler dose were computed using the logarithmically transformed assay results. CIs for GMFR were back transformations of confidence levels based on the Student t distribution for the mean logarithm of the fold rises. GMFRs were calculated using all participants with available data from both before 13vPnC toddler dose and after 13vPnC toddler dose blood draws.
Outcome measures
| Measure |
13vPnC Group 1 (Preterm Infant)
n=88 Participants
Preterm infant participants (gestational age \[GA\] less than \[\<\] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to \[\>=\] 32 weeks and \<37 weeks), Group 1B (GA \>=29 weeks and \<32 weeks) and Group 1C (GA \<29 weeks).
|
13vPnC Group 2 (Term Infant)
n=88 Participants
Term infant participants (GA \>=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
|
13vPnC Group 1C
Preterm participants with GA \<29 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
|
|---|---|---|---|
|
Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Toddler Pre-Dose to 1 Month After Toddler Dose
6A (n=83, 85)
|
10.52 fold rise
Interval 8.75 to 12.64
|
7.72 fold rise
Interval 6.18 to 9.65
|
—
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Toddler Pre-Dose to 1 Month After Toddler Dose
4 (n= 83, 85)
|
8.14 fold rise
Interval 6.61 to 10.04
|
9.61 fold rise
Interval 7.77 to 11.88
|
—
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Toddler Pre-Dose to 1 Month After Toddler Dose
6B (n=80, 85)
|
9.46 fold rise
Interval 7.81 to 11.45
|
7.61 fold rise
Interval 6.31 to 9.18
|
—
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Toddler Pre-Dose to 1 Month After Toddler Dose
9V (n=83, 85)
|
5.85 fold rise
Interval 5.05 to 6.78
|
4.92 fold rise
Interval 4.22 to 5.74
|
—
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Toddler Pre-Dose to 1 Month After Toddler Dose
14 (n=83, 85)
|
4.50 fold rise
Interval 3.76 to 5.38
|
4.65 fold rise
Interval 3.82 to 5.65
|
—
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Toddler Pre-Dose to 1 Month After Toddler Dose
18C (n=83, 85)
|
7.36 fold rise
Interval 6.29 to 8.61
|
9.14 fold rise
Interval 7.61 to 10.98
|
—
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Toddler Pre-Dose to 1 Month After Toddler Dose
19F (n=83, 85)
|
10.82 fold rise
Interval 8.88 to 13.17
|
12.31 fold rise
Interval 9.77 to 15.51
|
—
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Toddler Pre-Dose to 1 Month After Toddler Dose
23F (n=79, 83)
|
10.11 fold rise
Interval 8.13 to 12.57
|
10.15 fold rise
Interval 8.32 to 12.39
|
—
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Toddler Pre-Dose to 1 Month After Toddler Dose
1 (n=83, 85)
|
8.41 fold rise
Interval 6.94 to 10.2
|
9.98 fold rise
Interval 8.18 to 12.17
|
—
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Toddler Pre-Dose to 1 Month After Toddler Dose
3 (n=81, 84)
|
7.61 fold rise
Interval 5.79 to 10.01
|
5.23 fold rise
Interval 4.22 to 6.49
|
—
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Toddler Pre-Dose to 1 Month After Toddler Dose
5 (n=80, 85)
|
3.47 fold rise
Interval 3.04 to 3.97
|
3.46 fold rise
Interval 2.93 to 4.09
|
—
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Toddler Pre-Dose to 1 Month After Toddler Dose
7F (n=83, 85)
|
5.81 fold rise
Interval 5.12 to 6.61
|
6.07 fold rise
Interval 5.16 to 7.13
|
—
|
|
Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Toddler Pre-Dose to 1 Month After Toddler Dose
19A (n=83, 85)
|
6.45 fold rise
Interval 5.39 to 7.72
|
5.59 fold rise
Interval 4.53 to 6.9
|
—
|
SECONDARY outcome
Timeframe: 1 Month After Infant SeriesPopulation: Evaluable infant immunogenicity population included eligible participants who received all the assigned vaccinations (Infant Dose 1, 2 and 3), had blood drawn within required time frames, had at least 1 valid and determinate assay result for the proposed analysis, received no prohibited vaccines, and had no major protocol violations.
Percentage of participants achieving predefined antibody threshold \>=0.35 mcg/mL along with the corresponding 95 % CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. Exact 2-sided CI based on the observed proportion of participants. Here 'n' signifies participants with a determinate IgG concentration to the given serotype for each arm, respectively.
Outcome measures
| Measure |
13vPnC Group 1 (Preterm Infant)
n=24 Participants
Preterm infant participants (gestational age \[GA\] less than \[\<\] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to \[\>=\] 32 weeks and \<37 weeks), Group 1B (GA \>=29 weeks and \<32 weeks) and Group 1C (GA \<29 weeks).
|
13vPnC Group 2 (Term Infant)
n=50 Participants
Term infant participants (GA \>=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
|
13vPnC Group 1C
n=25 Participants
Preterm participants with GA \<29 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
|
|---|---|---|---|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After Infant Series: Group 1A, 1B, 1C
19F (n=24, 50, 25)
|
100.00 percentage of participants
Interval 85.75 to 100.0
|
98.00 percentage of participants
Interval 89.35 to 99.95
|
100.00 percentage of participants
Interval 86.28 to 100.0
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After Infant Series: Group 1A, 1B, 1C
23F (n=24, 50, 25)
|
91.67 percentage of participants
Interval 73.0 to 98.97
|
80.00 percentage of participants
Interval 66.28 to 89.97
|
92.00 percentage of participants
Interval 73.97 to 99.02
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After Infant Series: Group 1A, 1B, 1C
7F (n=24, 50, 25)
|
100.00 percentage of participants
Interval 85.75 to 100.0
|
98.00 percentage of participants
Interval 89.35 to 99.95
|
100.00 percentage of participants
Interval 86.28 to 100.0
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After Infant Series: Group 1A, 1B, 1C
19A (n=24, 50, 25)
|
100.00 percentage of participants
Interval 85.75 to 100.0
|
98.00 percentage of participants
Interval 89.35 to 99.95
|
100.00 percentage of participants
Interval 86.28 to 100.0
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After Infant Series: Group 1A, 1B, 1C
4 (n=24, 50, 25)
|
100.00 percentage of participants
Interval 85.75 to 100.0
|
96.00 percentage of participants
Interval 86.29 to 99.51
|
96.00 percentage of participants
Interval 79.65 to 99.9
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After Infant Series: Group 1A, 1B, 1C
6B (n=24, 50, 25)
|
79.17 percentage of participants
Interval 57.85 to 92.87
|
72.00 percentage of participants
Interval 57.51 to 83.77
|
68.00 percentage of participants
Interval 46.5 to 85.05
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After Infant Series: Group 1A, 1B, 1C
9V (n=24, 50, 25)
|
95.83 percentage of participants
Interval 78.88 to 99.89
|
98.00 percentage of participants
Interval 89.35 to 99.95
|
96.00 percentage of participants
Interval 79.65 to 99.9
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After Infant Series: Group 1A, 1B, 1C
14 (n=24, 50, 25)
|
100.00 percentage of participants
Interval 85.75 to 100.0
|
100.00 percentage of participants
Interval 92.89 to 100.0
|
100.00 percentage of participants
Interval 86.28 to 100.0
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After Infant Series: Group 1A, 1B, 1C
18C (n=24, 50, 25)
|
100.00 percentage of participants
Interval 85.75 to 100.0
|
94.00 percentage of participants
Interval 83.45 to 98.75
|
100.00 percentage of participants
Interval 86.28 to 100.0
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After Infant Series: Group 1A, 1B, 1C
1 (n=24, 50, 25)
|
100.00 percentage of participants
Interval 85.75 to 100.0
|
92.00 percentage of participants
Interval 80.77 to 97.78
|
92.00 percentage of participants
Interval 73.97 to 99.02
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After Infant Series: Group 1A, 1B, 1C
3 (n=24, 50, 25)
|
87.50 percentage of participants
Interval 67.64 to 97.34
|
86.00 percentage of participants
Interval 73.26 to 94.18
|
84.00 percentage of participants
Interval 63.92 to 95.46
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After Infant Series: Group 1A, 1B, 1C
5 (n=24, 50, 25)
|
79.17 percentage of participants
Interval 57.85 to 92.87
|
66.00 percentage of participants
Interval 51.23 to 78.79
|
76.00 percentage of participants
Interval 54.87 to 90.64
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After Infant Series: Group 1A, 1B, 1C
6A (n=24, 49, 25)
|
95.83 percentage of participants
Interval 78.88 to 99.89
|
81.63 percentage of participants
Interval 67.98 to 91.24
|
72.00 percentage of participants
Interval 50.61 to 87.93
|
SECONDARY outcome
Timeframe: 1 month after the toddler dosePopulation: Evaluable Toddler Immunogenicity Population included eligible participants who received all the assigned vaccinations (Infant Dose 1, 2, 3 and toddler dose), had blood drawn within required time frames, had at least 1 valid and determinate assay result for the proposed analysis, received no prohibited vaccines, and had no major protocol violations.
Percentage of participants achieving predefined antibody threshold \>=0.35 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. Exact 2-sided CI based on the observed proportion of participants. Here 'n' signifies participants with a determinate IgG antibody concentration to the given serotype for each arm, respectively.
Outcome measures
| Measure |
13vPnC Group 1 (Preterm Infant)
n=88 Participants
Preterm infant participants (gestational age \[GA\] less than \[\<\] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to \[\>=\] 32 weeks and \<37 weeks), Group 1B (GA \>=29 weeks and \<32 weeks) and Group 1C (GA \<29 weeks).
|
13vPnC Group 2 (Term Infant)
n=88 Participants
Term infant participants (GA \>=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
|
13vPnC Group 1C
Preterm participants with GA \<29 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
|
|---|---|---|---|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL 1 Month After the Toddler Dose
3 (n=85, 87)
|
70.59 percentage of participants
Interval 59.71 to 79.98
|
79.31 percentage of participants
Interval 69.29 to 87.25
|
—
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL 1 Month After the Toddler Dose
4 (n= 86, 87)
|
100.00 percentage of participants
Interval 95.8 to 100.0
|
100.00 percentage of participants
Interval 95.85 to 100.0
|
—
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL 1 Month After the Toddler Dose
6B (n=86, 87)
|
97.67 percentage of participants
Interval 91.85 to 99.72
|
100.00 percentage of participants
Interval 95.85 to 100.0
|
—
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL 1 Month After the Toddler Dose
9V (n=86, 87)
|
100.00 percentage of participants
Interval 95.8 to 100.0
|
100.00 percentage of participants
Interval 95.85 to 100.0
|
—
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL 1 Month After the Toddler Dose
14 (n=86, 87)
|
100.00 percentage of participants
Interval 95.8 to 100.0
|
100.00 percentage of participants
Interval 95.85 to 100.0
|
—
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL 1 Month After the Toddler Dose
18C (n=86, 87)
|
100.00 percentage of participants
Interval 95.8 to 100.0
|
98.85 percentage of participants
Interval 93.76 to 99.97
|
—
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL 1 Month After the Toddler Dose
19F (n=86, 87)
|
100.00 percentage of participants
Interval 95.8 to 100.0
|
100.00 percentage of participants
Interval 95.85 to 100.0
|
—
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL 1 Month After the Toddler Dose
23F (n=86, 87)
|
98.84 percentage of participants
Interval 93.69 to 99.97
|
100.00 percentage of participants
Interval 95.85 to 100.0
|
—
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL 1 Month After the Toddler Dose
1 (n=86, 87)
|
100.00 percentage of participants
Interval 95.8 to 100.0
|
100.00 percentage of participants
Interval 95.85 to 100.0
|
—
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL 1 Month After the Toddler Dose
5 (n=86, 87)
|
100.00 percentage of participants
Interval 95.8 to 100.0
|
100.00 percentage of participants
Interval 95.85 to 100.0
|
—
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL 1 Month After the Toddler Dose
6A (n=86, 87)
|
100.00 percentage of participants
Interval 95.8 to 100.0
|
100.00 percentage of participants
Interval 95.85 to 100.0
|
—
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL 1 Month After the Toddler Dose
7F (n=86, 87)
|
100.00 percentage of participants
Interval 95.8 to 100.0
|
100.00 percentage of participants
Interval 95.85 to 100.0
|
—
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL 1 Month After the Toddler Dose
19A (n=86, 87)
|
100.00 percentage of participants
Interval 95.8 to 100.0
|
100.00 percentage of participants
Interval 95.85 to 100.0
|
—
|
SECONDARY outcome
Timeframe: 1 month after the toddler dosePopulation: Evaluable Toddler Immunogenicity Population. Here 'n' signifies participants with a determinate IgG antibody concentration to the given serotype for each arm, respectively.
Percentage of participants achieving predefined antibody threshold \>=0.35 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. Exact 2-sided CI based on the observed proportion of participants.
Outcome measures
| Measure |
13vPnC Group 1 (Preterm Infant)
n=21 Participants
Preterm infant participants (gestational age \[GA\] less than \[\<\] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to \[\>=\] 32 weeks and \<37 weeks), Group 1B (GA \>=29 weeks and \<32 weeks) and Group 1C (GA \<29 weeks).
|
13vPnC Group 2 (Term Infant)
n=46 Participants
Term infant participants (GA \>=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
|
13vPnC Group 1C
n=21 Participants
Preterm participants with GA \<29 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
|
|---|---|---|---|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level >=0.35 mcg/mL 1 Month After Toddler Dose: Group 1A, 1B, 1C
4 (n=21, 45, 20)
|
100.00 percentage of participants
Interval 83.89 to 100.0
|
100.00 percentage of participants
Interval 92.13 to 100.0
|
100.00 percentage of participants
Interval 83.16 to 100.0
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level >=0.35 mcg/mL 1 Month After Toddler Dose: Group 1A, 1B, 1C
19A (n=21, 45, 20)
|
100.00 percentage of participants
Interval 83.89 to 100.0
|
100.00 percentage of participants
Interval 92.13 to 100.0
|
100.00 percentage of participants
Interval 83.16 to 100.0
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level >=0.35 mcg/mL 1 Month After Toddler Dose: Group 1A, 1B, 1C
6B (n=21, 45, 20)
|
100.00 percentage of participants
Interval 83.89 to 100.0
|
95.56 percentage of participants
Interval 84.85 to 99.46
|
100.00 percentage of participants
Interval 83.16 to 100.0
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level >=0.35 mcg/mL 1 Month After Toddler Dose: Group 1A, 1B, 1C
9V (n=21, 45, 20)
|
100.00 percentage of participants
Interval 83.89 to 100.0
|
100.00 percentage of participants
Interval 92.13 to 100.0
|
100.00 percentage of participants
Interval 83.16 to 100.0
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level >=0.35 mcg/mL 1 Month After Toddler Dose: Group 1A, 1B, 1C
14 (n=21, 45, 20)
|
100.00 percentage of participants
Interval 83.89 to 100.0
|
100.00 percentage of participants
Interval 92.13 to 100.0
|
100.00 percentage of participants
Interval 83.16 to 100.0
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level >=0.35 mcg/mL 1 Month After Toddler Dose: Group 1A, 1B, 1C
18C (n=21, 45, 20)
|
100.00 percentage of participants
Interval 83.89 to 100.0
|
100.00 percentage of participants
Interval 92.13 to 100.0
|
100.00 percentage of participants
Interval 83.16 to 100.0
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level >=0.35 mcg/mL 1 Month After Toddler Dose: Group 1A, 1B, 1C
19F (n=21, 45, 20)
|
100.00 percentage of participants
Interval 83.89 to 100.0
|
100.00 percentage of participants
Interval 92.13 to 100.0
|
100.00 percentage of participants
Interval 83.16 to 100.0
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level >=0.35 mcg/mL 1 Month After Toddler Dose: Group 1A, 1B, 1C
23F (n=21, 45, 20)
|
100.00 percentage of participants
Interval 83.89 to 100.0
|
97.78 percentage of participants
Interval 88.23 to 99.94
|
100.00 percentage of participants
Interval 83.16 to 100.0
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level >=0.35 mcg/mL 1 Month After Toddler Dose: Group 1A, 1B, 1C
1 (n=21, 45, 20)
|
100.00 percentage of participants
Interval 83.89 to 100.0
|
100.00 percentage of participants
Interval 92.13 to 100.0
|
100.00 percentage of participants
Interval 83.16 to 100.0
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level >=0.35 mcg/mL 1 Month After Toddler Dose: Group 1A, 1B, 1C
3 (n=21, 44, 20)
|
95.24 percentage of participants
Interval 76.18 to 99.88
|
68.18 percentage of participants
Interval 52.42 to 81.39
|
50.00 percentage of participants
Interval 27.2 to 72.8
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level >=0.35 mcg/mL 1 Month After Toddler Dose: Group 1A, 1B, 1C
5 (n=21, 45, 20)
|
100.00 percentage of participants
Interval 83.89 to 100.0
|
100.00 percentage of participants
Interval 92.13 to 100.0
|
100.00 percentage of participants
Interval 83.16 to 100.0
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level >=0.35 mcg/mL 1 Month After Toddler Dose: Group 1A, 1B, 1C
6A (n=21, 45, 20)
|
100.00 percentage of participants
Interval 83.89 to 100.0
|
100.00 percentage of participants
Interval 92.13 to 100.0
|
100.00 percentage of participants
Interval 83.16 to 100.0
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level >=0.35 mcg/mL 1 Month After Toddler Dose: Group 1A, 1B, 1C
7F (n=21, 45, 20)
|
100.00 percentage of participants
Interval 83.89 to 100.0
|
100.00 percentage of participants
Interval 92.13 to 100.0
|
100.00 percentage of participants
Interval 83.16 to 100.0
|
SECONDARY outcome
Timeframe: Before Toddler Dose (pre-vaccination)Population: Evaluable Toddler Immunogenicity Population. Here 'n' signifies participants with a determinate IgG concentration to the given serotype for each arm, respectively.
Geometric mean concentration (GMC) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. GMCs were calculated using all participants with available data for the specified blood draw. CIs were calculated as back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Outcome measures
| Measure |
13vPnC Group 1 (Preterm Infant)
n=88 Participants
Preterm infant participants (gestational age \[GA\] less than \[\<\] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to \[\>=\] 32 weeks and \<37 weeks), Group 1B (GA \>=29 weeks and \<32 weeks) and Group 1C (GA \<29 weeks).
|
13vPnC Group 2 (Term Infant)
n=88 Participants
Term infant participants (GA \>=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
|
13vPnC Group 1C
Preterm participants with GA \<29 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
|
|---|---|---|---|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose
9V (n= 85, 85)
|
0.39 mcg/mL
Interval 0.33 to 0.46
|
0.62 mcg/mL
Interval 0.53 to 0.72
|
—
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose
7F (n=85, 85)
|
0.72 mcg/mL
Interval 0.63 to 0.82
|
0.84 mcg/mL
Interval 0.73 to 0.96
|
—
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose
4 (n= 85, 85)
|
0.31 mcg/mL
Interval 0.26 to 0.37
|
0.41 mcg/mL
Interval 0.34 to 0.49
|
—
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose
6B (n= 82, 85)
|
0.48 mcg/mL
Interval 0.39 to 0.58
|
0.94 mcg/mL
Interval 0.79 to 1.11
|
—
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose
14 (n= 85, 85)
|
2.02 mcg/mL
Interval 1.68 to 2.43
|
2.36 mcg/mL
Interval 1.94 to 2.87
|
—
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose
18C (n=85, 85)
|
0.32 mcg/mL
Interval 0.28 to 0.37
|
0.30 mcg/mL
Interval 0.26 to 0.36
|
—
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose
19F (n=85, 85)
|
0.68 mcg/mL
Interval 0.57 to 0.8
|
0.93 mcg/mL
Interval 0.79 to 1.1
|
—
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose
23F (n=81, 83)
|
0.24 mcg/mL
Interval 0.18 to 0.31
|
0.40 mcg/mL
Interval 0.33 to 0.48
|
—
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose
1 (n=85, 85)
|
0.39 mcg/mL
Interval 0.34 to 0.46
|
0.41 mcg/mL
Interval 0.35 to 0.48
|
—
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose
3 (n=84, 84)
|
0.07 mcg/mL
Interval 0.05 to 0.09
|
0.11 mcg/mL
Interval 0.09 to 0.14
|
—
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose
5 (n=82, 85)
|
0.74 mcg/mL
Interval 0.64 to 0.87
|
1.06 mcg/mL
Interval 0.9 to 1.26
|
—
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose
6A (n=85, 85)
|
0.54 mcg/mL
Interval 0.45 to 0.65
|
1.01 mcg/mL
Interval 0.82 to 1.24
|
—
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose
19A (n=85, 85)
|
0.86 mcg/mL
Interval 0.72 to 1.03
|
1.57 mcg/mL
Interval 1.27 to 1.92
|
—
|
SECONDARY outcome
Timeframe: 1 Month After Toddler DosePopulation: Evaluable Toddler Immunogenicity Population.
Geometric mean concentration (GMC) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. GMCs were calculated using all participants with available data for the specified blood draw. CIs were calculated as back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. Here 'n' signifies participants with a determinate IgG concentration to the given serotype for each arm, respectively.
Outcome measures
| Measure |
13vPnC Group 1 (Preterm Infant)
n=88 Participants
Preterm infant participants (gestational age \[GA\] less than \[\<\] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to \[\>=\] 32 weeks and \<37 weeks), Group 1B (GA \>=29 weeks and \<32 weeks) and Group 1C (GA \<29 weeks).
|
13vPnC Group 2 (Term Infant)
n=88 Participants
Term infant participants (GA \>=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
|
13vPnC Group 1C
Preterm participants with GA \<29 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
|
|---|---|---|---|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose
4 (n= 86, 87)
|
2.57 mcg/mL
Interval 2.18 to 3.03
|
3.97 mcg/mL
Interval 3.32 to 4.74
|
—
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose
6B (n=86, 87)
|
4.42 mcg/mL
Interval 3.64 to 5.37
|
7.27 mcg/mL
Interval 6.09 to 8.68
|
—
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose
9V (n=86, 87)
|
2.30 mcg/mL
Interval 1.99 to 2.66
|
3.06 mcg/mL
Interval 2.62 to 3.56
|
—
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose
14 (n=86, 87)
|
9.24 mcg/mL
Interval 7.66 to 11.14
|
11.02 mcg/mL
Interval 9.44 to 12.86
|
—
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose
18C (n=86, 87)
|
2.37 mcg/mL
Interval 2.02 to 2.79
|
2.81 mcg/mL
Interval 2.32 to 3.4
|
—
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose
19F (n=86, 87)
|
7.38 mcg/mL
Interval 6.23 to 8.76
|
11.67 mcg/mL
Interval 9.47 to 14.36
|
—
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose
23F (n=86, 87)
|
2.45 mcg/mL
Interval 2.01 to 2.98
|
4.03 mcg/mL
Interval 3.36 to 4.85
|
—
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose
1 (n=86, 87)
|
3.32 mcg/mL
Interval 2.83 to 3.89
|
4.09 mcg/mL
Interval 3.42 to 4.89
|
—
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose
3 (n=85, 87)
|
0.52 mcg/mL
Interval 0.44 to 0.62
|
0.57 mcg/mL
Interval 0.49 to 0.65
|
—
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose
5 (n=86, 87)
|
2.63 mcg/mL
Interval 2.28 to 3.02
|
3.72 mcg/mL
Interval 3.19 to 4.33
|
—
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose
6A (n=86, 87)
|
5.64 mcg/mL
Interval 4.86 to 6.54
|
7.84 mcg/mL
Interval 6.59 to 9.33
|
—
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose
7F (n=86, 87)
|
4.25 mcg/mL
Interval 3.75 to 4.82
|
5.13 mcg/mL
Interval 4.48 to 5.87
|
—
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose
19A (n=86, 87)
|
5.57 mcg/mL
Interval 4.66 to 6.65
|
8.84 mcg/mL
Interval 7.45 to 10.48
|
—
|
SECONDARY outcome
Timeframe: 1 Year After Toddler DosePopulation: Evaluable Toddler Immunogenicity Population. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure during specified follow-up period and 'n' signifies participants with a determinate IgG concentration to the given serotype during specified follow-up period for each arm, respectively.
The persistence of the antibody response induced by 13vPnC was described by geometric mean concentration (GMC) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A). GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMCs were calculated using all participants with available data for the specified blood draw. CIs were calculated as back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Outcome measures
| Measure |
13vPnC Group 1 (Preterm Infant)
n=80 Participants
Preterm infant participants (gestational age \[GA\] less than \[\<\] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to \[\>=\] 32 weeks and \<37 weeks), Group 1B (GA \>=29 weeks and \<32 weeks) and Group 1C (GA \<29 weeks).
|
13vPnC Group 2 (Term Infant)
n=80 Participants
Term infant participants (GA \>=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
|
13vPnC Group 1C
Preterm participants with GA \<29 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
|
|---|---|---|---|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose
4 (n= 80, 79)
|
0.30 mcg/mL
Interval 0.25 to 0.36
|
0.37 mcg/mL
Interval 0.31 to 0.44
|
—
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose
6B (n=80, 80)
|
1.26 mcg/mL
Interval 1.02 to 1.57
|
2.01 mcg/mL
Interval 1.69 to 2.39
|
—
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose
9V (n=80, 80)
|
0.61 mcg/mL
Interval 0.48 to 0.78
|
0.98 mcg/mL
Interval 0.82 to 1.19
|
—
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose
14 (n=79, 80)
|
1.43 mcg/mL
Interval 1.15 to 1.78
|
1.73 mcg/mL
Interval 1.4 to 2.14
|
—
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose
18C (n=80, 79)
|
0.33 mcg/mL
Interval 0.27 to 0.41
|
0.66 mcg/mL
Interval 0.54 to 0.81
|
—
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose
19F (n=80, 79)
|
0.96 mcg/mL
Interval 0.8 to 1.15
|
1.78 mcg/mL
Interval 1.4 to 2.26
|
—
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose
23F (n=79, 80)
|
0.59 mcg/mL
Interval 0.47 to 0.74
|
1.24 mcg/mL
Interval 1.01 to 1.52
|
—
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose
1 (n=78, 80)
|
0.40 mcg/mL
Interval 0.35 to 0.46
|
0.53 mcg/mL
Interval 0.45 to 0.62
|
—
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose
3 (n=78, 78)
|
0.13 mcg/mL
Interval 0.1 to 0.17
|
0.22 mcg/mL
Interval 0.16 to 0.3
|
—
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose
5 (n=79, 78)
|
1.10 mcg/mL
Interval 0.91 to 1.32
|
1.63 mcg/mL
Interval 1.35 to 1.97
|
—
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose
6A (n=80, 79)
|
1.08 mcg/mL
Interval 0.89 to 1.32
|
1.59 mcg/mL
Interval 1.34 to 1.9
|
—
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose
7F (n=79, 80)
|
0.68 mcg/mL
Interval 0.59 to 0.8
|
0.83 mcg/mL
Interval 0.72 to 0.96
|
—
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose
19A (n=80, 80)
|
1.61 mcg/mL
Interval 1.22 to 2.12
|
3.16 mcg/mL
Interval 2.53 to 3.95
|
—
|
SECONDARY outcome
Timeframe: 2 Years After Toddler DosePopulation: Evaluable Toddler Immunogenicity Population. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure during specified follow-up period and 'n' signifies participants with a determinate IgG concentration to the given serotype during specified follow-up period for each arm, respectively.
The persistence of the antibody response induced by 13vPnC was described by geometric mean concentration (GMC) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A). GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMCs were calculated using all participants with available data for the specified blood draw. CIs were calculated as back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Outcome measures
| Measure |
13vPnC Group 1 (Preterm Infant)
n=71 Participants
Preterm infant participants (gestational age \[GA\] less than \[\<\] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to \[\>=\] 32 weeks and \<37 weeks), Group 1B (GA \>=29 weeks and \<32 weeks) and Group 1C (GA \<29 weeks).
|
13vPnC Group 2 (Term Infant)
n=71 Participants
Term infant participants (GA \>=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
|
13vPnC Group 1C
Preterm participants with GA \<29 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
|
|---|---|---|---|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose
4 (n=70, 71)
|
0.19 mcg/mL
Interval 0.16 to 0.23
|
0.24 mcg/mL
Interval 0.2 to 0.29
|
—
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose
6B (n=70, 70)
|
1.44 mcg/mL
Interval 1.13 to 1.85
|
2.70 mcg/mL
Interval 2.1 to 3.48
|
—
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose
9V (n=71, 70)
|
0.74 mcg/mL
Interval 0.58 to 0.94
|
0.99 mcg/mL
Interval 0.8 to 1.23
|
—
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose
14 (n=70, 71)
|
1.06 mcg/mL
Interval 0.78 to 1.43
|
1.37 mcg/mL
Interval 1.03 to 1.82
|
—
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose
18C (n=69, 71)
|
0.32 mcg/mL
Interval 0.24 to 0.42
|
0.57 mcg/mL
Interval 0.47 to 0.69
|
—
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose
19F (n=71, 70)
|
1.10 mcg/mL
Interval 0.83 to 1.46
|
2.43 mcg/mL
Interval 1.71 to 3.44
|
—
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose
23F (n=71, 71)
|
1.03 mcg/mL
Interval 0.77 to 1.38
|
1.83 mcg/mL
Interval 1.42 to 2.37
|
—
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose
1 (n=70, 69)
|
0.32 mcg/mL
Interval 0.26 to 0.38
|
0.39 mcg/mL
Interval 0.32 to 0.47
|
—
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose
3 (n=65, 63)
|
0.17 mcg/mL
Interval 0.12 to 0.25
|
0.27 mcg/mL
Interval 0.18 to 0.4
|
—
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose
5 (n=69, 69)
|
1.34 mcg/mL
Interval 1.07 to 1.68
|
1.97 mcg/mL
Interval 1.6 to 2.41
|
—
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose
6A (n=71, 71)
|
1.41 mcg/mL
Interval 1.09 to 1.82
|
2.10 mcg/mL
Interval 1.64 to 2.7
|
—
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose
7F (n=71, 70)
|
0.60 mcg/mL
Interval 0.5 to 0.71
|
0.67 mcg/mL
Interval 0.57 to 0.8
|
—
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose
19A (n=71, 71)
|
2.33 mcg/mL
Interval 1.76 to 3.1
|
4.36 mcg/mL
Interval 3.4 to 5.61
|
—
|
SECONDARY outcome
Timeframe: 1 Month After Infant SeriesPopulation: Evaluable Infant Immunogenicity Population.
Geometric mean concentration (GMC) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. GMCs were calculated using all participants with available data for the specified blood draw. CIs were calculated as back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. Here 'n' signifies participants with a determinate IgG concentration to the given serotype for each arm, respectively.
Outcome measures
| Measure |
13vPnC Group 1 (Preterm Infant)
n=24 Participants
Preterm infant participants (gestational age \[GA\] less than \[\<\] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to \[\>=\] 32 weeks and \<37 weeks), Group 1B (GA \>=29 weeks and \<32 weeks) and Group 1C (GA \<29 weeks).
|
13vPnC Group 2 (Term Infant)
n=50 Participants
Term infant participants (GA \>=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
|
13vPnC Group 1C
n=25 Participants
Preterm participants with GA \<29 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
|
|---|---|---|---|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Infant Series: Group 1A, 1B, 1C
4 (n=24, 50, 25)
|
2.50 mcg/mL
Interval 1.92 to 3.24
|
1.86 mcg/mL
Interval 1.47 to 2.37
|
1.73 mcg/mL
Interval 1.2 to 2.49
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Infant Series: Group 1A, 1B, 1C
6B (n=24, 50, 25)
|
1.23 mcg/mL
Interval 0.74 to 2.07
|
0.61 mcg/mL
Interval 0.42 to 0.88
|
0.62 mcg/mL
Interval 0.3 to 1.31
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Infant Series: Group 1A, 1B, 1C
9V (n=24, 50, 25)
|
1.44 mcg/mL
Interval 1.02 to 2.03
|
1.25 mcg/mL
Interval 1.02 to 1.53
|
1.14 mcg/mL
Interval 0.78 to 1.65
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Infant Series: Group 1A, 1B, 1C
14 (n=24, 50, 25)
|
8.95 mcg/mL
Interval 6.44 to 12.42
|
7.13 mcg/mL
Interval 5.65 to 8.98
|
6.95 mcg/mL
Interval 4.2 to 11.5
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Infant Series: Group 1A, 1B, 1C
18C (n=24, 50, 25)
|
2.58 mcg/mL
Interval 1.97 to 3.37
|
1.78 mcg/mL
Interval 1.44 to 2.19
|
1.72 mcg/mL
Interval 1.22 to 2.43
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Infant Series: Group 1A, 1B, 1C
19F (n=24, 50, 25)
|
2.46 mcg/mL
Interval 1.77 to 3.43
|
2.06 mcg/mL
Interval 1.67 to 2.55
|
2.28 mcg/mL
Interval 1.61 to 3.24
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Infant Series: Group 1A, 1B, 1C
23F (n=24, 50, 25)
|
1.38 mcg/mL
Interval 0.84 to 2.27
|
0.65 mcg/mL
Interval 0.48 to 0.89
|
0.95 mcg/mL
Interval 0.66 to 1.35
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Infant Series: Group 1A, 1B, 1C
1 (n=24, 50, 25)
|
1.56 mcg/mL
Interval 1.12 to 2.18
|
1.21 mcg/mL
Interval 0.96 to 1.52
|
1.10 mcg/mL
Interval 0.75 to 1.6
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Infant Series: Group 1A, 1B, 1C
3 (n=24, 50, 25)
|
1.28 mcg/mL
Interval 0.86 to 1.9
|
0.75 mcg/mL
Interval 0.6 to 0.93
|
0.67 mcg/mL
Interval 0.49 to 0.91
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Infant Series: Group 1A, 1B, 1C
5 (n=24, 50, 25)
|
0.85 mcg/mL
Interval 0.57 to 1.28
|
0.50 mcg/mL
Interval 0.36 to 0.69
|
0.46 mcg/mL
Interval 0.26 to 0.82
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Infant Series: Group 1A, 1B, 1C
6A (n=24, 49, 25)
|
1.74 mcg/mL
Interval 1.19 to 2.55
|
1.15 mcg/mL
Interval 0.84 to 1.57
|
0.98 mcg/mL
Interval 0.59 to 1.65
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Infant Series: Group 1A, 1B, 1C
7F (n=24, 50, 25)
|
2.43 mcg/mL
Interval 1.56 to 3.77
|
1.99 mcg/mL
Interval 1.61 to 2.46
|
2.18 mcg/mL
Interval 1.55 to 3.06
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Infant Series: Group 1A, 1B, 1C
19A (n=24, 50, 25)
|
3.43 mcg/mL
Interval 2.52 to 4.67
|
2.60 mcg/mL
Interval 2.08 to 3.25
|
2.88 mcg/mL
Interval 2.06 to 4.02
|
SECONDARY outcome
Timeframe: Before Toddler Dose (pre-vaccination)Population: Evaluable Toddler Immunogenicity Population.
Geometric mean concentration (GMC) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. GMCs were calculated using all participants with available data for the specified blood draw. CIs were calculated as back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. Here 'n' signifies participants with a determinate IgG concentration to the given serotype for each arm, respectively.
Outcome measures
| Measure |
13vPnC Group 1 (Preterm Infant)
n=21 Participants
Preterm infant participants (gestational age \[GA\] less than \[\<\] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to \[\>=\] 32 weeks and \<37 weeks), Group 1B (GA \>=29 weeks and \<32 weeks) and Group 1C (GA \<29 weeks).
|
13vPnC Group 2 (Term Infant)
n=46 Participants
Term infant participants (GA \>=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
|
13vPnC Group 1C
n=21 Participants
Preterm participants with GA \<29 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
|
|---|---|---|---|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose: Group 1A, 1B, 1C
4 (n= 20, 44, 21)
|
0.37 mcg/mL
Interval 0.27 to 0.5
|
0.28 mcg/mL
Interval 0.22 to 0.36
|
0.32 mcg/mL
Interval 0.22 to 0.46
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose: Group 1A, 1B, 1C
6B (n= 20, 42, 20)
|
0.59 mcg/mL
Interval 0.42 to 0.83
|
0.42 mcg/mL
Interval 0.31 to 0.56
|
0.49 mcg/mL
Interval 0.3 to 0.8
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose: Group 1A, 1B, 1C
9V (n= 20, 44, 21)
|
0.43 mcg/mL
Interval 0.3 to 0.6
|
0.36 mcg/mL
Interval 0.28 to 0.46
|
0.44 mcg/mL
Interval 0.33 to 0.6
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose: Group 1A, 1B, 1C
14 (n=20, 44, 21)
|
2.48 mcg/mL
Interval 1.74 to 3.54
|
1.83 mcg/mL
Interval 1.4 to 2.38
|
2.04 mcg/mL
Interval 1.33 to 3.12
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose: Group 1A, 1B, 1C
18C (n=20, 44, 21)
|
0.35 mcg/mL
Interval 0.25 to 0.48
|
0.30 mcg/mL
Interval 0.24 to 0.36
|
0.34 mcg/mL
Interval 0.24 to 0.49
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose: Group 1A, 1B, 1C
19F (n=20, 44, 21)
|
0.96 mcg/mL
Interval 0.57 to 1.61
|
0.58 mcg/mL
Interval 0.48 to 0.71
|
0.67 mcg/mL
Interval 0.52 to 0.87
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose: Group 1A, 1B, 1C
23F (n=20, 41, 20)
|
0.31 mcg/mL
Interval 0.19 to 0.52
|
0.21 mcg/mL
Interval 0.14 to 0.32
|
0.24 mcg/mL
Interval 0.14 to 0.41
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose: Group 1A, 1B, 1C
1 (n=20, 44, 21)
|
0.37 mcg/mL
Interval 0.27 to 0.52
|
0.39 mcg/mL
Interval 0.32 to 0.48
|
0.42 mcg/mL
Interval 0.3 to 0.61
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose: Group 1A, 1B, 1C
3 (n=20, 44, 20)
|
0.13 mcg/mL
Interval 0.07 to 0.24
|
0.06 mcg/mL
Interval 0.04 to 0.08
|
0.05 mcg/mL
Interval 0.02 to 0.09
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose: Group 1A, 1B, 1C
5 (n=19, 43, 20)
|
0.75 mcg/mL
Interval 0.56 to 1.01
|
0.71 mcg/mL
Interval 0.55 to 0.9
|
0.81 mcg/mL
Interval 0.62 to 1.06
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose: Group 1A, 1B, 1C
6A (n=20, 44, 21)
|
0.66 mcg/mL
Interval 0.46 to 0.93
|
0.49 mcg/mL
Interval 0.38 to 0.63
|
0.55 mcg/mL
Interval 0.35 to 0.85
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose: Group 1A, 1B, 1C
7F (n=20, 44, 21)
|
0.71 mcg/mL
Interval 0.55 to 0.92
|
0.64 mcg/mL
Interval 0.54 to 0.77
|
0.91 mcg/mL
Interval 0.69 to 1.19
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose: Group 1A, 1B, 1C
19A (n=20, 44, 21)
|
1.20 mcg/mL
Interval 0.76 to 1.89
|
0.72 mcg/mL
Interval 0.57 to 0.91
|
0.92 mcg/mL
Interval 0.66 to 1.3
|
SECONDARY outcome
Timeframe: 1 Month After Toddler DosePopulation: Evaluable Toddler Immunogenicity Population.
Geometric mean concentration (GMC) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. GMCs were calculated using all participants with available data for the specified blood draw. CIs were calculated as back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. Here 'n' signifies participants with a determinate IgG concentration to the given serotype for each arm, respectively.
Outcome measures
| Measure |
13vPnC Group 1 (Preterm Infant)
n=21 Participants
Preterm infant participants (gestational age \[GA\] less than \[\<\] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to \[\>=\] 32 weeks and \<37 weeks), Group 1B (GA \>=29 weeks and \<32 weeks) and Group 1C (GA \<29 weeks).
|
13vPnC Group 2 (Term Infant)
n=46 Participants
Term infant participants (GA \>=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
|
13vPnC Group 1C
n=21 Participants
Preterm participants with GA \<29 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
|
|---|---|---|---|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose: Group 1A, 1B, 1C
4 (n= 21, 45, 20)
|
3.58 mcg/mL
Interval 2.66 to 4.83
|
2.87 mcg/mL
Interval 2.29 to 3.59
|
1.41 mcg/mL
Interval 1.05 to 1.88
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose: Group 1A, 1B, 1C
6B (n= 21, 45, 20)
|
6.28 mcg/mL
Interval 4.6 to 8.58
|
4.28 mcg/mL
Interval 3.18 to 5.75
|
3.29 mcg/mL
Interval 2.24 to 4.84
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose: Group 1A, 1B, 1C
9V (n= 21, 45, 20)
|
2.99 mcg/mL
Interval 2.26 to 3.96
|
2.23 mcg/mL
Interval 1.81 to 2.74
|
1.88 mcg/mL
Interval 1.41 to 2.52
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose: Group 1A, 1B, 1C
14 (n=21, 45, 20)
|
13.20 mcg/mL
Interval 9.65 to 18.05
|
8.84 mcg/mL
Interval 6.58 to 11.9
|
7.01 mcg/mL
Interval 5.15 to 9.54
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose: Group 1A, 1B, 1C
18C (n=21, 45, 20)
|
3.71 mcg/mL
Interval 2.77 to 4.97
|
2.40 mcg/mL
Interval 1.95 to 2.96
|
1.45 mcg/mL
Interval 1.05 to 2.0
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose: Group 1A, 1B, 1C
19F (n=21, 45, 20)
|
10.45 mcg/mL
Interval 8.2 to 13.32
|
7.39 mcg/mL
Interval 5.62 to 9.71
|
5.12 mcg/mL
Interval 3.91 to 6.72
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose: Group 1A, 1B, 1C
23F (n=21, 45, 20)
|
3.57 mcg/mL
Interval 2.54 to 5.02
|
2.41 mcg/mL
Interval 1.8 to 3.21
|
1.71 mcg/mL
Interval 1.12 to 2.62
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose: Group 1A, 1B, 1C
1 (n=21, 45, 20)
|
4.78 mcg/mL
Interval 3.61 to 6.34
|
3.31 mcg/mL
Interval 2.62 to 4.18
|
2.28 mcg/mL
Interval 1.74 to 2.99
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose: Group 1A, 1B, 1C
3 (n=21, 44, 20)
|
0.88 mcg/mL
Interval 0.61 to 1.25
|
0.51 mcg/mL
Interval 0.41 to 0.64
|
0.31 mcg/mL
Interval 0.23 to 0.43
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose: Group 1A, 1B, 1C
5 (n=21, 45, 20)
|
3.41 mcg/mL
Interval 2.69 to 4.32
|
2.66 mcg/mL
Interval 2.14 to 3.3
|
1.95 mcg/mL
Interval 1.54 to 2.47
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose: Group 1A, 1B, 1C
6A (n=21, 45, 20)
|
6.95 mcg/mL
Interval 5.18 to 9.33
|
5.81 mcg/mL
Interval 4.68 to 7.22
|
4.23 mcg/mL
Interval 3.22 to 5.56
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose: Group 1A, 1B, 1C
7F (n=21, 45, 20)
|
5.29 mcg/mL
Interval 4.11 to 6.8
|
4.09 mcg/mL
Interval 3.41 to 4.89
|
3.69 mcg/mL
Interval 2.84 to 4.8
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose: Group 1A, 1B, 1C
19A (n=21, 45, 20)
|
8.63 mcg/mL
Interval 6.51 to 11.43
|
5.28 mcg/mL
Interval 3.96 to 7.04
|
3.96 mcg/mL
Interval 3.17 to 4.96
|
SECONDARY outcome
Timeframe: 1 Year After Toddler DosePopulation: Evaluable Toddler Immunogenicity Population. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure during specified follow-up period and 'n' signifies participants with a determinate IgG concentration to the given serotype during specified follow-up period for each arm, respectively.
The persistence of the antibody response induced by 13vPnC was described by geometric mean concentration (GMC) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A). GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMCs were calculated using all participants with available data for the specified blood draw. CIs were calculated as back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Outcome measures
| Measure |
13vPnC Group 1 (Preterm Infant)
n=18 Participants
Preterm infant participants (gestational age \[GA\] less than \[\<\] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to \[\>=\] 32 weeks and \<37 weeks), Group 1B (GA \>=29 weeks and \<32 weeks) and Group 1C (GA \<29 weeks).
|
13vPnC Group 2 (Term Infant)
n=43 Participants
Term infant participants (GA \>=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
|
13vPnC Group 1C
n=19 Participants
Preterm participants with GA \<29 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
|
|---|---|---|---|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose: Group 1A, 1B, 1C
19A (n=18, 43, 19)
|
2.12 mcg/mL
Interval 0.9 to 5.01
|
1.50 mcg/mL
Interval 1.05 to 2.14
|
1.45 mcg/mL
Interval 0.95 to 2.21
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose: Group 1A, 1B, 1C
4 (n=18, 43, 19)
|
0.30 mcg/mL
Interval 0.19 to 0.46
|
0.29 mcg/mL
Interval 0.23 to 0.37
|
0.32 mcg/mL
Interval 0.21 to 0.49
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose: Group 1A, 1B, 1C
6B (n=18, 43, 19)
|
1.49 mcg/mL
Interval 0.84 to 2.66
|
1.28 mcg/mL
Interval 0.96 to 1.7
|
1.06 mcg/mL
Interval 0.7 to 1.6
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose: Group 1A, 1B, 1C
9V (n=18, 43, 19)
|
0.59 mcg/mL
Interval 0.37 to 0.93
|
0.56 mcg/mL
Interval 0.42 to 0.75
|
0.80 mcg/mL
Interval 0.4 to 1.59
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose: Group 1A, 1B, 1C
14 (n=18, 42, 19)
|
1.37 mcg/mL
Interval 0.86 to 2.19
|
1.38 mcg/mL
Interval 1.09 to 1.75
|
1.62 mcg/mL
Interval 0.83 to 3.16
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose: Group 1A, 1B, 1C
18C (n=18, 43, 19)
|
0.39 mcg/mL
Interval 0.26 to 0.57
|
0.31 mcg/mL
Interval 0.24 to 0.41
|
0.32 mcg/mL
Interval 0.17 to 0.59
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose: Group 1A, 1B, 1C
19F (n=18, 43, 19)
|
1.27 mcg/mL
Interval 0.81 to 2.0
|
0.89 mcg/mL
Interval 0.7 to 1.14
|
0.86 mcg/mL
Interval 0.62 to 1.21
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose: Group 1A, 1B, 1C
23F (n=18, 42, 19)
|
0.79 mcg/mL
Interval 0.5 to 1.26
|
0.54 mcg/mL
Interval 0.4 to 0.74
|
0.53 mcg/mL
Interval 0.3 to 0.91
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose: Group 1A, 1B, 1C
1 (n=18, 41, 19)
|
0.39 mcg/mL
Interval 0.3 to 0.5
|
0.38 mcg/mL
Interval 0.32 to 0.47
|
0.45 mcg/mL
Interval 0.31 to 0.64
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose: Group 1A, 1B, 1C
3 (n=18, 41, 19)
|
0.17 mcg/mL
Interval 0.1 to 0.29
|
0.12 mcg/mL
Interval 0.09 to 0.17
|
0.11 mcg/mL
Interval 0.05 to 0.23
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose: Group 1A, 1B, 1C
5 (n=18, 42, 19)
|
0.87 mcg/mL
Interval 0.59 to 1.28
|
1.24 mcg/mL
Interval 0.93 to 1.64
|
1.05 mcg/mL
Interval 0.77 to 1.44
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose: Group 1A, 1B, 1C
6A (n=18, 43, 19)
|
1.17 mcg/mL
Interval 0.73 to 1.87
|
1.05 mcg/mL
Interval 0.8 to 1.4
|
1.07 mcg/mL
Interval 0.72 to 1.59
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose: Group 1A, 1B, 1C
7F (n=18, 42, 19)
|
0.65 mcg/mL
Interval 0.47 to 0.91
|
0.65 mcg/mL
Interval 0.52 to 0.81
|
0.81 mcg/mL
Interval 0.61 to 1.08
|
SECONDARY outcome
Timeframe: 2 Years After Toddler DosePopulation: Evaluable Toddler Immunogenicity Population. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure during specified follow-up period and 'n' signifies participants with a determinate IgG concentration to the given serotype during specified follow-up period for each arm, respectively.
The persistence of the antibody response induced by 13vPnC was described by geometric mean concentration (GMC) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A). GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMCs were calculated using all participants with available data for the specified blood draw. CIs were calculated as back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Outcome measures
| Measure |
13vPnC Group 1 (Preterm Infant)
n=17 Participants
Preterm infant participants (gestational age \[GA\] less than \[\<\] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to \[\>=\] 32 weeks and \<37 weeks), Group 1B (GA \>=29 weeks and \<32 weeks) and Group 1C (GA \<29 weeks).
|
13vPnC Group 2 (Term Infant)
n=36 Participants
Term infant participants (GA \>=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
|
13vPnC Group 1C
n=18 Participants
Preterm participants with GA \<29 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
|
|---|---|---|---|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose: Group 1A, 1B, 1C
4 (n=17, 35, 18)
|
0.17 mcg/mL
Interval 0.11 to 0.28
|
0.19 mcg/mL
Interval 0.16 to 0.24
|
0.21 mcg/mL
Interval 0.13 to 0.33
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose: Group 1A, 1B, 1C
6B (n=17, 35, 18)
|
1.39 mcg/mL
Interval 0.81 to 2.4
|
1.81 mcg/mL
Interval 1.28 to 2.56
|
0.96 mcg/mL
Interval 0.58 to 1.6
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose: Group 1A, 1B, 1C
9V (n=17, 36, 18)
|
0.68 mcg/mL
Interval 0.39 to 1.17
|
0.83 mcg/mL
Interval 0.59 to 1.16
|
0.63 mcg/mL
Interval 0.36 to 1.12
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose: Group 1A, 1B, 1C
14 (n=17, 35, 18)
|
1.27 mcg/mL
Interval 0.59 to 2.76
|
1.02 mcg/mL
Interval 0.71 to 1.48
|
0.96 mcg/mL
Interval 0.47 to 1.96
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose: Group 1A, 1B, 1C
18C (n=16, 35, 18)
|
0.34 mcg/mL
Interval 0.18 to 0.65
|
0.35 mcg/mL
Interval 0.23 to 0.52
|
0.26 mcg/mL
Interval 0.16 to 0.44
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose: Group 1A, 1B, 1C
19F (n=17, 36, 18)
|
1.53 mcg/mL
Interval 0.83 to 2.81
|
0.93 mcg/mL
Interval 0.68 to 1.28
|
1.13 mcg/mL
Interval 0.5 to 2.53
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose: Group 1A, 1B, 1C
23F (n=17, 36, 18)
|
1.14 mcg/mL
Interval 0.6 to 2.15
|
1.41 mcg/mL
Interval 0.95 to 2.09
|
0.50 mcg/mL
Interval 0.27 to 0.9
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose: Group 1A, 1B, 1C
1 (n=17, 35, 18)
|
0.32 mcg/mL
Interval 0.23 to 0.44
|
0.35 mcg/mL
Interval 0.26 to 0.47
|
0.26 mcg/mL
Interval 0.18 to 0.39
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose: Group 1A, 1B, 1C
3 (n=16, 33, 16)
|
0.20 mcg/mL
Interval 0.1 to 0.39
|
0.19 mcg/mL
Interval 0.11 to 0.3
|
0.14 mcg/mL
Interval 0.06 to 0.34
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose: Group 1A, 1B, 1C
5 (n=17, 35, 17)
|
1.18 mcg/mL
Interval 0.67 to 2.11
|
1.67 mcg/mL
Interval 1.25 to 2.25
|
0.97 mcg/mL
Interval 0.62 to 1.5
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose: Group 1A, 1B, 1C
6A (n=17, 36, 18)
|
1.32 mcg/mL
Interval 0.87 to 1.99
|
1.58 mcg/mL
Interval 1.1 to 2.26
|
1.20 mcg/mL
Interval 0.63 to 2.3
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose: Group 1A, 1B, 1C
7F (n=17, 36, 18)
|
0.61 mcg/mL
Interval 0.39 to 0.96
|
0.68 mcg/mL
Interval 0.54 to 0.84
|
0.46 mcg/mL
Interval 0.32 to 0.67
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose: Group 1A, 1B, 1C
19A (n=17, 36, 18)
|
3.04 mcg/mL
Interval 1.64 to 5.64
|
2.46 mcg/mL
Interval 1.69 to 3.58
|
1.64 mcg/mL
Interval 0.83 to 3.23
|
SECONDARY outcome
Timeframe: 1 Month After Infant SeriesPopulation: Evaluable Infant Immunogenicity Population. Here n' signifies participants with a determinate OPA titer to the given serotype for each arm respectively.
Antibody-mediated serum OPA against the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) was measured centrally using a pneumococcal OPA assay. Results were expressed as OPA titers. OPA titers were logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs).
Outcome measures
| Measure |
13vPnC Group 1 (Preterm Infant)
n=99 Participants
Preterm infant participants (gestational age \[GA\] less than \[\<\] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to \[\>=\] 32 weeks and \<37 weeks), Group 1B (GA \>=29 weeks and \<32 weeks) and Group 1C (GA \<29 weeks).
|
13vPnC Group 2 (Term Infant)
n=98 Participants
Term infant participants (GA \>=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
|
13vPnC Group 1C
Preterm participants with GA \<29 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
|
|---|---|---|---|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Infant Series
9V (n=54, 60)
|
151 titer
Interval 70.8 to 321.1
|
211 titer
Interval 108.2 to 413.4
|
—
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Infant Series
3 (n=83, 86)
|
61 titer
Interval 51.2 to 73.2
|
57 titer
Interval 46.3 to 69.5
|
—
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Infant Series
5 (n=83, 85)
|
37 titer
Interval 25.9 to 53.9
|
64 titer
Interval 47.2 to 86.9
|
—
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Infant Series
4 (n=58, 62)
|
1231 titer
Interval 986.5 to 1537.3
|
923 titer
Interval 746.9 to 1139.7
|
—
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Infant Series
6B (n=51, 61)
|
835 titer
Interval 478.6 to 1455.2
|
732 titer
Interval 494.0 to 1086.0
|
—
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Infant Series
14 (n=55, 66)
|
1298 titer
Interval 968.3 to 1740.3
|
1033 titer
Interval 735.7 to 1451.0
|
—
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Infant Series
18C (n=56, 63)
|
2931 titer
Interval 2341.2 to 3669.3
|
2057 titer
Interval 1594.0 to 2655.1
|
—
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Infant Series
19F (n= 55, 58)
|
417 titer
Interval 330.7 to 525.8
|
335 titer
Interval 237.2 to 472.3
|
—
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Infant Series
23F (n=55, 60)
|
733 titer
Interval 539.3 to 997.3
|
582 titer
Interval 413.7 to 817.8
|
—
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Infant Series
1 (n=88, 87)
|
10 titer
Interval 8.0 to 13.4
|
13 titer
Interval 10.0 to 16.8
|
—
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Infant Series
6A (n=88, 88)
|
1566 titer
Interval 1312.3 to 1869.0
|
1287 titer
Interval 980.1 to 1691.1
|
—
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Infant Series
7F (n=93, 86)
|
1605 titer
Interval 1277.9 to 2014.7
|
1539 titer
Interval 1297.4 to 1826.3
|
—
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Infant Series
19A (n=92, 86)
|
283 titer
Interval 232.4 to 344.1
|
244 titer
Interval 204.1 to 290.6
|
—
|
SECONDARY outcome
Timeframe: Before the toddler dose (pre-vaccination)Population: Evaluable Toddler Immunogenicity Population. Here 'n' signifies participants with a determinate OPA titer to the given serotype for each arm respectively.
Antibody-mediated serum OPA against the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) was measured centrally using a pneumococcal OPA assay. Results were expressed as OPA titers. OPA titers were logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs).
Outcome measures
| Measure |
13vPnC Group 1 (Preterm Infant)
n=88 Participants
Preterm infant participants (gestational age \[GA\] less than \[\<\] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to \[\>=\] 32 weeks and \<37 weeks), Group 1B (GA \>=29 weeks and \<32 weeks) and Group 1C (GA \<29 weeks).
|
13vPnC Group 2 (Term Infant)
n=88 Participants
Term infant participants (GA \>=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
|
13vPnC Group 1C
Preterm participants with GA \<29 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
|
|---|---|---|---|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before Toddler Dose
4 (n= 56, 59)
|
10 titer
Interval 6.0 to 15.3
|
13 titer
Interval 7.9 to 21.9
|
—
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before Toddler Dose
6B (n= 59, 62)
|
12 titer
Interval 6.8 to 20.1
|
15 titer
Interval 8.5 to 25.6
|
—
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before Toddler Dose
9V (n=52, 63)
|
11 titer
Interval 6.2 to 20.9
|
7 titer
Interval 4.9 to 11.1
|
—
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before Toddler Dose
14 (n= 60, 55)
|
242 titer
Interval 148.5 to 394.0
|
389 titer
Interval 260.4 to 582.2
|
—
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before Toddler Dose
18C (n= 54, 58)
|
32 titer
Interval 16.1 to 61.7
|
51 titer
Interval 26.8 to 98.3
|
—
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before Toddler Dose
19F (n= 57, 60)
|
6 titer
Interval 4.1 to 7.4
|
4 titer
Interval 3.8 to 4.7
|
—
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before Toddler Dose
23F (n=59, 62)
|
11 titer
Interval 6.9 to 19.0
|
16 titer
Interval 9.6 to 26.6
|
—
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before Toddler Dose
1 (n=76, 80)
|
6 titer
Interval 4.5 to 6.8
|
4 titer
Interval 3.9 to 4.8
|
—
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before Toddler Dose
3 (n=73, 77)
|
8 titer
Interval 6.2 to 10.0
|
8 titer
Interval 6.6 to 10.4
|
—
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before Toddler Dose
5 (n=74, 79)
|
5 titer
Interval 4.2 to 6.0
|
5 titer
Interval 4.2 to 5.6
|
—
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before Toddler Dose
6A (n=69, 76)
|
45 titer
Interval 25.2 to 81.1
|
91 titer
Interval 56.6 to 146.3
|
—
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before Toddler Dose
7F (n=75, 79)
|
228 titer
Interval 137.6 to 377.1
|
188 titer
Interval 109.3 to 323.1
|
—
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before Toddler Dose
19A (n=77, 79)
|
9 titer
Interval 6.3 to 12.0
|
10 titer
Interval 7.1 to 14.8
|
—
|
SECONDARY outcome
Timeframe: 1 Month After Toddler DosePopulation: Evaluable Toddler Immunogenicity Population. Here 'n' signifies participants with a determinate OPA titer to the given serotype for each arm respectively.
Antibody-mediated serum OPA against the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) was measured centrally using a pneumococcal OPA assay. Results were expressed as OPA titers. OPA titers were logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs).
Outcome measures
| Measure |
13vPnC Group 1 (Preterm Infant)
n=88 Participants
Preterm infant participants (gestational age \[GA\] less than \[\<\] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to \[\>=\] 32 weeks and \<37 weeks), Group 1B (GA \>=29 weeks and \<32 weeks) and Group 1C (GA \<29 weeks).
|
13vPnC Group 2 (Term Infant)
n=88 Participants
Term infant participants (GA \>=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
|
13vPnC Group 1C
Preterm participants with GA \<29 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
|
|---|---|---|---|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Toddler Dose
23F (n=65, 63)
|
1048 titer
Interval 738.6 to 1488.0
|
1657 titer
Interval 1217.7 to 2255.0
|
—
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Toddler Dose
4 (n= 67, 61)
|
1154 titer
Interval 879.2 to 1514.5
|
1757 titer
Interval 1329.1 to 2322.4
|
—
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Toddler Dose
6B (n= 64, 61)
|
1229 titer
Interval 877.2 to 1722.1
|
1406 titer
Interval 1003.4 to 1970.3
|
—
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Toddler Dose
9V (n=60, 58)
|
1871 titer
Interval 1217.8 to 2873.6
|
2542 titer
Interval 1711.6 to 3775.2
|
—
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Toddler Dose
14 (n= 62, 62)
|
1294 titer
Interval 969.0 to 1728.4
|
1651 titer
Interval 1300.1 to 2097.1
|
—
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Toddler Dose
18C (n= 62, 63)
|
2464 titer
Interval 1696.0 to 3579.4
|
4510 titer
Interval 3399.7 to 5981.7
|
—
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Toddler Dose
19F (n= 61, 62)
|
376 titer
Interval 229.1 to 617.1
|
640 titer
Interval 431.5 to 948.3
|
—
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Toddler Dose
1 (n=80, 83)
|
59 titer
Interval 43.7 to 78.6
|
107 titer
Interval 83.0 to 137.0
|
—
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Toddler Dose
3 (n=78, 79)
|
114 titer
Interval 97.1 to 132.7
|
121 titer
Interval 103.4 to 140.4
|
—
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Toddler Dose
5 (n=80, 83)
|
166 titer
Interval 127.9 to 216.3
|
260 titer
Interval 203.9 to 331.9
|
—
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Toddler Dose
6A (n=78, 74)
|
1978 titer
Interval 1571.5 to 2489.7
|
3154 titer
Interval 2606.0 to 3816.0
|
—
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Toddler Dose
7F (n=81, 82)
|
2915 titer
Interval 2453.4 to 3462.7
|
3154 titer
Interval 2746.2 to 3622.4
|
—
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Toddler Dose
19A (n=81, 82)
|
558 titer
Interval 456.3 to 682.6
|
825 titer
Interval 692.4 to 983.8
|
—
|
SECONDARY outcome
Timeframe: 1 Year After Toddler DosePopulation: Evaluable Toddler Immunogenicity Population. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure during specified follow-up period and 'n' signifies participants with a determinate OPA titer to the given serotype during specified follow-up period for each arm, respectively.
Antibody-mediated serum OPA against the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) was measured centrally using a pneumococcal OPA assay. Results were expressed as OPA titers. OPA titers were logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs).
Outcome measures
| Measure |
13vPnC Group 1 (Preterm Infant)
n=80 Participants
Preterm infant participants (gestational age \[GA\] less than \[\<\] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to \[\>=\] 32 weeks and \<37 weeks), Group 1B (GA \>=29 weeks and \<32 weeks) and Group 1C (GA \<29 weeks).
|
13vPnC Group 2 (Term Infant)
n=80 Participants
Term infant participants (GA \>=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
|
13vPnC Group 1C
Preterm participants with GA \<29 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
|
|---|---|---|---|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Year After Toddler Dose
7F (n=71, 71)
|
599 titer
Interval 411.0 to 873.3
|
533 titer
Interval 348.3 to 814.1
|
—
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Year After Toddler Dose
4 (n= 66, 59)
|
24 titer
Interval 12.9 to 45.5
|
29 titer
Interval 15.2 to 54.5
|
—
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Year After Toddler Dose
6B (n= 65, 59)
|
38 titer
Interval 19.0 to 74.9
|
36 titer
Interval 19.2 to 68.8
|
—
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Year After Toddler Dose
9V (n=61, 63)
|
141 titer
Interval 67.5 to 293.1
|
244 titer
Interval 126.3 to 469.7
|
—
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Year After Toddler Dose
14 (n= 59, 54)
|
276 titer
Interval 169.0 to 449.4
|
372 titer
Interval 236.1 to 586.5
|
—
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Year After Toddler Dose
18C (n= 62, 60)
|
33 titer
Interval 16.4 to 67.4
|
121 titer
Interval 56.9 to 258.1
|
—
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Year After Toddler Dose
19F (n= 67, 57)
|
11 titer
Interval 6.2 to 17.7
|
18 titer
Interval 9.6 to 35.4
|
—
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Year After Toddler Dose
23F (n=67, 62)
|
45 titer
Interval 23.7 to 86.6
|
168 titer
Interval 92.4 to 303.9
|
—
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Year After Toddler Dose
1 (n=76, 74)
|
5 titer
Interval 4.2 to 6.3
|
5 titer
Interval 4.3 to 5.8
|
—
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Year After Toddler Dose
3 (n=76, 70)
|
11 titer
Interval 8.6 to 15.4
|
13 titer
Interval 9.2 to 18.7
|
—
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Year After Toddler Dose
5 (n=72, 70)
|
8 titer
Interval 5.6 to 10.4
|
10 titer
Interval 7.0 to 13.3
|
—
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Year After Toddler Dose
6A (n=70, 70)
|
98 titer
Interval 53.0 to 183.0
|
255 titer
Interval 152.9 to 424.8
|
—
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Year After Toddler Dose
19A (n=74, 73)
|
28 titer
Interval 17.2 to 43.9
|
54 titer
Interval 34.2 to 85.5
|
—
|
SECONDARY outcome
Timeframe: 2 Years After Toddler DosePopulation: Evaluable Toddler Immunogenicity Population. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure during specified follow-up period and 'n' signifies participants with a determinate OPA titer to the given serotype during specified follow-up period for each arm, respectively.
Antibody-mediated serum OPA against the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) was measured using a pneumococcal OPA assay. Results were expressed as OPA titers. OPA titers were logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs).
Outcome measures
| Measure |
13vPnC Group 1 (Preterm Infant)
n=71 Participants
Preterm infant participants (gestational age \[GA\] less than \[\<\] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to \[\>=\] 32 weeks and \<37 weeks), Group 1B (GA \>=29 weeks and \<32 weeks) and Group 1C (GA \<29 weeks).
|
13vPnC Group 2 (Term Infant)
n=71 Participants
Term infant participants (GA \>=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
|
13vPnC Group 1C
Preterm participants with GA \<29 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
|
|---|---|---|---|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 2 Years After Toddler Dose
1 (n=70, 68)
|
5 titer
Interval 4.1 to 5.4
|
4 titer
Interval 3.9 to 4.6
|
—
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 2 Years After Toddler Dose
3 (n=69, 66)
|
11 titer
Interval 8.1 to 15.2
|
16 titer
Interval 10.7 to 24.2
|
—
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 2 Years After Toddler Dose
5 (n=68, 69)
|
5 titer
Interval 4.1 to 5.6
|
7 titer
Interval 5.4 to 9.4
|
—
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 2 Years After Toddler Dose
6A (n=68, 62)
|
42 titer
Interval 21.5 to 81.1
|
102 titer
Interval 53.7 to 193.4
|
—
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 2 Years After Toddler Dose
7F (n=64, 65)
|
170 titer
Interval 87.7 to 330.9
|
269 titer
Interval 155.6 to 463.7
|
—
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 2 Years After Toddler Dose
19A (n=68, 67)
|
22 titer
Interval 13.6 to 37.1
|
50 titer
Interval 30.1 to 82.6
|
—
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 2 Years After Toddler Dose
4 (n= 46, 54)
|
15 titer
Interval 7.0 to 32.9
|
17 titer
Interval 9.0 to 32.6
|
—
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 2 Years After Toddler Dose
6B (n= 56, 48)
|
29 titer
Interval 13.7 to 59.9
|
27 titer
Interval 12.4 to 58.2
|
—
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 2 Years After Toddler Dose
9V (n=50, 55)
|
132 titer
Interval 57.5 to 301.5
|
75 titer
Interval 34.7 to 163.7
|
—
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 2 Years After Toddler Dose
14 (n= 49, 45)
|
262 titer
Interval 142.0 to 482.8
|
296 titer
Interval 161.6 to 543.8
|
—
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 2 Years After Toddler Dose
18C (n= 56, 56)
|
14 titer
Interval 7.1 to 25.9
|
29 titer
Interval 14.3 to 57.9
|
—
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 2 Years After Toddler Dose
19F (n= 60, 58)
|
13 titer
Interval 7.4 to 22.5
|
20 titer
Interval 10.1 to 39.9
|
—
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 2 Years After Toddler Dose
23F (n=58, 59)
|
60 titer
Interval 29.7 to 122.2
|
135 titer
Interval 71.2 to 255.3
|
—
|
SECONDARY outcome
Timeframe: 1 Month After Infant SeriesPopulation: Evaluable Infant Immunogenicity Population. Here 'n' signifies participants with a determinate OPA antibody titer to the given serotype for each arm respectively.
Percentage of participants achieving OPA titer \>=LLOQ for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) determined in blood samples of all participants was presented. Exact 2-sided CI based on observed proportion of participants. LLOQ for each serotype: 1=18; 3=12; 4=21; 5=29; 6A=37; 6B=43; 7F=210; 9V=345; 14=35; 18C=31; 19A=18; 19F=48; 23F=13.
Outcome measures
| Measure |
13vPnC Group 1 (Preterm Infant)
n=99 Participants
Preterm infant participants (gestational age \[GA\] less than \[\<\] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to \[\>=\] 32 weeks and \<37 weeks), Group 1B (GA \>=29 weeks and \<32 weeks) and Group 1C (GA \<29 weeks).
|
13vPnC Group 2 (Term Infant)
n=98 Participants
Term infant participants (GA \>=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
|
13vPnC Group 1C
Preterm participants with GA \<29 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
|
|---|---|---|---|
|
Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series
4 (n= 58, 62)
|
100.00 percentage of participants
Interval 93.84 to 100.0
|
100.00 percentage of participants
Interval 94.22 to 100.0
|
—
|
|
Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series
6B (n= 51, 61)
|
90.20 percentage of participants
Interval 78.59 to 96.74
|
95.08 percentage of participants
Interval 86.29 to 98.97
|
—
|
|
Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series
9V (n= 54, 60)
|
64.81 percentage of participants
Interval 50.62 to 77.32
|
71.67 percentage of participants
Interval 58.56 to 82.55
|
—
|
|
Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series
14 (n= 55, 66)
|
100.00 percentage of participants
Interval 93.51 to 100.0
|
96.97 percentage of participants
Interval 89.48 to 99.63
|
—
|
|
Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series
18C (n= 56, 63)
|
100.00 percentage of participants
Interval 93.62 to 100.0
|
100.00 percentage of participants
Interval 94.31 to 100.0
|
—
|
|
Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series
19F (n= 55, 58)
|
100.00 percentage of participants
Interval 93.51 to 100.0
|
96.55 percentage of participants
Interval 88.09 to 99.58
|
—
|
|
Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series
23F (n= 55, 60)
|
98.18 percentage of participants
Interval 90.28 to 99.95
|
96.67 percentage of participants
Interval 88.47 to 99.59
|
—
|
|
Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series
1 (n= 88, 87)
|
40.91 percentage of participants
Interval 30.54 to 51.91
|
51.72 percentage of participants
Interval 40.75 to 62.58
|
—
|
|
Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series
3 (n=83, 86)
|
100.00 percentage of participants
Interval 95.65 to 100.0
|
95.35 percentage of participants
Interval 88.52 to 98.72
|
—
|
|
Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series
5 (n= 83, 85)
|
67.47 percentage of participants
Interval 56.3 to 77.35
|
83.53 percentage of participants
Interval 73.91 to 90.69
|
—
|
|
Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series
6A (n= 88, 88)
|
100.00 percentage of participants
Interval 95.89 to 100.0
|
97.73 percentage of participants
Interval 92.03 to 99.72
|
—
|
|
Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series
7F (n= 93, 86)
|
97.85 percentage of participants
Interval 92.45 to 99.74
|
100.00 percentage of participants
Interval 95.8 to 100.0
|
—
|
|
Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series
19A (n= 92, 86)
|
98.91 percentage of participants
Interval 94.09 to 99.97
|
100.00 percentage of participants
Interval 95.8 to 100.0
|
—
|
SECONDARY outcome
Timeframe: Before Toddler Dose (pre-vaccination)Population: Evaluable Toddler Immunogenicity Population. Here 'n' signifies participants with a determinate OPA antibody titer to the given serotype for each arm respectively.
Percentage of participants achieving OPA titer \>=LLOQ for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) determined in blood samples of all participants was presented. Exact 2-sided CI based on observed proportion of participants. LLOQ for each serotype: 1=18; 3=12; 4=21; 5=29; 6A=37; 6B=43; 7F=210; 9V=345; 14=35; 18C=31; 19A=18; 19F=48; 23F=13.
Outcome measures
| Measure |
13vPnC Group 1 (Preterm Infant)
n=88 Participants
Preterm infant participants (gestational age \[GA\] less than \[\<\] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to \[\>=\] 32 weeks and \<37 weeks), Group 1B (GA \>=29 weeks and \<32 weeks) and Group 1C (GA \<29 weeks).
|
13vPnC Group 2 (Term Infant)
n=88 Participants
Term infant participants (GA \>=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
|
13vPnC Group 1C
Preterm participants with GA \<29 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
|
|---|---|---|---|
|
Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) Before Toddler Dose
4 (n=56, 59)
|
21.43 percentage of participants
Interval 11.59 to 34.44
|
30.51 percentage of participants
Interval 19.19 to 43.87
|
—
|
|
Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) Before Toddler Dose
6B (n=59, 62)
|
22.03 percentage of participants
Interval 12.29 to 34.73
|
27.42 percentage of participants
Interval 16.85 to 40.23
|
—
|
|
Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) Before Toddler Dose
9V (n=52, 63)
|
19.23 percentage of participants
Interval 9.63 to 32.53
|
12.70 percentage of participants
Interval 5.65 to 23.5
|
—
|
|
Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) Before Toddler Dose
14 (n=60, 55)
|
86.67 percentage of participants
Interval 75.41 to 94.06
|
94.55 percentage of participants
Interval 84.88 to 98.86
|
—
|
|
Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) Before Toddler Dose
18C (n=54, 58)
|
44.44 percentage of participants
Interval 30.92 to 58.6
|
55.17 percentage of participants
Interval 41.54 to 68.26
|
—
|
|
Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) Before Toddler Dose
19F (n=57, 60)
|
8.77 percentage of participants
Interval 2.91 to 19.3
|
1.67 percentage of participants
Interval 0.04 to 8.94
|
—
|
|
Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) Before Toddler Dose
23F (n=59, 62)
|
23.73 percentage of participants
Interval 13.62 to 36.59
|
37.10 percentage of participants
Interval 25.16 to 50.31
|
—
|
|
Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) Before Toddler Dose
1 (n=76, 80)
|
11.84 percentage of participants
Interval 5.56 to 21.29
|
3.75 percentage of participants
Interval 0.78 to 10.57
|
—
|
|
Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) Before Toddler Dose
3 (n=73, 77)
|
32.88 percentage of participants
Interval 22.33 to 44.87
|
40.26 percentage of participants
Interval 29.23 to 52.06
|
—
|
|
Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) Before Toddler Dose
5 (n=74, 79)
|
8.11 percentage of participants
Interval 3.03 to 16.82
|
7.59 percentage of participants
Interval 2.84 to 15.8
|
—
|
|
Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) Before Toddler Dose
6A (n=69, 76)
|
52.17 percentage of participants
Interval 39.8 to 64.35
|
72.37 percentage of participants
Interval 60.91 to 82.01
|
—
|
|
Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) Before Toddler Dose
7F (n=75, 79)
|
78.67 percentage of participants
Interval 67.68 to 87.29
|
73.42 percentage of participants
Interval 62.28 to 82.73
|
—
|
|
Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) Before Toddler Dose
19A (n=77, 79)
|
25.97 percentage of participants
Interval 16.64 to 37.23
|
29.11 percentage of participants
Interval 19.43 to 40.42
|
—
|
SECONDARY outcome
Timeframe: 1 Month After Toddler DosePopulation: Evaluable Toddler Immunogenicity Population. Here 'n' signifies participants with a determinate OPA titer to the given serotype during specified follow-up period for each arm, respectively.
Percentage of participants achieving OPA titer \>=LLOQ for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) determined in blood samples of all participants was presented. Exact 2-sided CI based on observed proportion of participants. LLOQ for each serotype: 1=18; 3=12; 4=21; 5=29; 6A=37; 6B=43; 7F=210; 9V=345; 14=35; 18C=31; 19A=18; 19F=48; 23F=13.
Outcome measures
| Measure |
13vPnC Group 1 (Preterm Infant)
n=88 Participants
Preterm infant participants (gestational age \[GA\] less than \[\<\] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to \[\>=\] 32 weeks and \<37 weeks), Group 1B (GA \>=29 weeks and \<32 weeks) and Group 1C (GA \<29 weeks).
|
13vPnC Group 2 (Term Infant)
n=88 Participants
Term infant participants (GA \>=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
|
13vPnC Group 1C
Preterm participants with GA \<29 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
|
|---|---|---|---|
|
Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Toddler Dose
4 (n= 67, 61)
|
100.00 percentage of participants
Interval 94.64 to 100.0
|
100.00 percentage of participants
Interval 94.13 to 100.0
|
—
|
|
Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Toddler Dose
6B (n= 64, 61)
|
98.44 percentage of participants
Interval 91.6 to 99.96
|
98.36 percentage of participants
Interval 91.2 to 99.96
|
—
|
|
Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Toddler Dose
9V (n= 60, 58)
|
95.00 percentage of participants
Interval 86.08 to 98.96
|
96.55 percentage of participants
Interval 88.09 to 99.58
|
—
|
|
Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Toddler Dose
14 (n= 62, 62)
|
100.00 percentage of participants
Interval 94.22 to 100.0
|
100.00 percentage of participants
Interval 94.22 to 100.0
|
—
|
|
Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Toddler Dose
18C (n= 62, 63)
|
98.39 percentage of participants
Interval 91.34 to 99.96
|
100.00 percentage of participants
Interval 94.31 to 100.0
|
—
|
|
Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Toddler Dose
19F (n= 61, 62)
|
88.52 percentage of participants
Interval 77.78 to 95.26
|
95.16 percentage of participants
Interval 86.5 to 98.99
|
—
|
|
Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Toddler Dose
23F (n= 65, 63)
|
98.46 percentage of participants
Interval 91.72 to 99.96
|
98.41 percentage of participants
Interval 91.47 to 99.96
|
—
|
|
Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Toddler Dose
1 (n= 80, 83)
|
87.50 percentage of participants
Interval 78.21 to 93.84
|
93.98 percentage of participants
Interval 86.5 to 98.02
|
—
|
|
Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Toddler Dose
3 (n=78, 79)
|
100.00 percentage of participants
Interval 95.38 to 100.0
|
98.73 percentage of participants
Interval 93.15 to 99.97
|
—
|
|
Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Toddler Dose
5 (n= 80, 83)
|
96.25 percentage of participants
Interval 89.43 to 99.22
|
97.59 percentage of participants
Interval 91.57 to 99.71
|
—
|
|
Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Toddler Dose
6A (n=78, 74)
|
100.00 percentage of participants
Interval 95.38 to 100.0
|
100.00 percentage of participants
Interval 95.14 to 100.0
|
—
|
|
Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Toddler Dose
7F (n= 81, 82)
|
100.00 percentage of participants
Interval 95.55 to 100.0
|
100.00 percentage of participants
Interval 95.6 to 100.0
|
—
|
|
Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Toddler Dose
19A (n= 81, 82)
|
100.00 percentage of participants
Interval 95.55 to 100.0
|
100.00 percentage of participants
Interval 95.6 to 100.0
|
—
|
SECONDARY outcome
Timeframe: 1 Year After Toddler DosePopulation: Evaluable Toddler Immunogenicity Population. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure during specified follow-up period and 'n' signifies participants with a determinate OPA titer to the given serotype during specified follow-up period for each arm, respectively.
Percentage of participants achieving OPA titer \>=LLOQ for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) determined in blood samples of all participants was presented. Exact 2-sided CI based on observed proportion of participants. LLOQ for each serotype: 1=18; 3=12; 4=21; 5=29; 6A=37; 6B=43; 7F=210; 9V=345; 14=35; 18C=31; 19A=18; 19F=48; 23F=13.
Outcome measures
| Measure |
13vPnC Group 1 (Preterm Infant)
n=80 Participants
Preterm infant participants (gestational age \[GA\] less than \[\<\] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to \[\>=\] 32 weeks and \<37 weeks), Group 1B (GA \>=29 weeks and \<32 weeks) and Group 1C (GA \<29 weeks).
|
13vPnC Group 2 (Term Infant)
n=80 Participants
Term infant participants (GA \>=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
|
13vPnC Group 1C
Preterm participants with GA \<29 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
|
|---|---|---|---|
|
Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Year After Toddler Dose
18C (n= 62, 60)
|
38.7 percentage of participants
Interval 26.6 to 51.9
|
61.7 percentage of participants
Interval 48.2 to 73.9
|
—
|
|
Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Year After Toddler Dose
5 (n= 72, 70)
|
20.8 percentage of participants
Interval 12.2 to 32.0
|
31.4 percentage of participants
Interval 20.9 to 43.6
|
—
|
|
Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Year After Toddler Dose
6A (n=70, 70)
|
62.9 percentage of participants
Interval 50.5 to 74.1
|
81.4 percentage of participants
Interval 70.3 to 89.7
|
—
|
|
Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Year After Toddler Dose
4 (n= 66, 59)
|
34.8 percentage of participants
Interval 23.5 to 47.6
|
42.4 percentage of participants
Interval 29.6 to 55.9
|
—
|
|
Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Year After Toddler Dose
6B (n= 65, 59)
|
41.5 percentage of participants
Interval 29.4 to 54.4
|
47.5 percentage of participants
Interval 34.3 to 60.9
|
—
|
|
Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Year After Toddler Dose
9V (n= 61, 63)
|
62.3 percentage of participants
Interval 49.0 to 74.4
|
73.0 percentage of participants
Interval 60.3 to 83.4
|
—
|
|
Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Year After Toddler Dose
14 (n= 59, 54)
|
86.4 percentage of participants
Interval 75.0 to 94.0
|
90.7 percentage of participants
Interval 79.7 to 96.9
|
—
|
|
Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Year After Toddler Dose
19F (n= 67, 57)
|
17.9 percentage of participants
Interval 9.6 to 29.2
|
29.8 percentage of participants
Interval 18.4 to 43.4
|
—
|
|
Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Year After Toddler Dose
23F (n= 67, 62)
|
49.3 percentage of participants
Interval 36.8 to 61.8
|
77.4 percentage of participants
Interval 65.0 to 87.1
|
—
|
|
Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Year After Toddler Dose
1 (n= 76, 74)
|
10.5 percentage of participants
Interval 4.7 to 19.7
|
10.8 percentage of participants
Interval 4.8 to 20.2
|
—
|
|
Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Year After Toddler Dose
3 (n=76, 70)
|
47.4 percentage of participants
Interval 35.8 to 59.2
|
48.6 percentage of participants
Interval 36.4 to 60.8
|
—
|
|
Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Year After Toddler Dose
7F (n= 71, 71)
|
93.0 percentage of participants
Interval 84.3 to 97.7
|
90.1 percentage of participants
Interval 80.7 to 95.9
|
—
|
|
Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Year After Toddler Dose
19A (n= 74, 73)
|
54.1 percentage of participants
Interval 42.1 to 65.7
|
72.6 percentage of participants
Interval 60.9 to 82.4
|
—
|
SECONDARY outcome
Timeframe: 2 Years After Toddler DosePopulation: Evaluable Toddler Immunogenicity Population. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure during specified follow-up period and 'n' signifies participants with a determinate OPA titer to the given serotype during specified follow-up period for each arm, respectively.
Percentage of participants achieving OPA titer \>=LLOQ for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) determined in blood samples of all participants was presented. Exact 2-sided CI based on observed proportion of participants. LLOQ for each serotype: 1=18; 3=12; 4=21; 5=29; 6A=37; 6B=43; 7F=210; 9V=345; 14=35; 18C=31; 19A=18; 19F=48; 23F=13.
Outcome measures
| Measure |
13vPnC Group 1 (Preterm Infant)
n=71 Participants
Preterm infant participants (gestational age \[GA\] less than \[\<\] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to \[\>=\] 32 weeks and \<37 weeks), Group 1B (GA \>=29 weeks and \<32 weeks) and Group 1C (GA \<29 weeks).
|
13vPnC Group 2 (Term Infant)
n=71 Participants
Term infant participants (GA \>=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
|
13vPnC Group 1C
Preterm participants with GA \<29 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
|
|---|---|---|---|
|
Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 2 Years After Toddler Dose
3 (n=69, 66)
|
46.4 percentage of participants
Interval 34.3 to 58.8
|
51.5 percentage of participants
Interval 38.9 to 64.0
|
—
|
|
Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 2 Years After Toddler Dose
5 (n= 68, 69)
|
7.4 percentage of participants
Interval 2.4 to 16.3
|
21.7 percentage of participants
Interval 12.7 to 33.3
|
—
|
|
Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 2 Years After Toddler Dose
6A (n=68, 62)
|
44.1 percentage of participants
Interval 32.1 to 56.7
|
64.5 percentage of participants
Interval 51.3 to 76.3
|
—
|
|
Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 2 Years After Toddler Dose
7F (n= 64, 65)
|
68.8 percentage of participants
Interval 55.9 to 79.8
|
80.0 percentage of participants
Interval 68.2 to 88.9
|
—
|
|
Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 2 Years After Toddler Dose
4 (n= 46, 54)
|
21.7 percentage of participants
Interval 10.9 to 36.4
|
29.6 percentage of participants
Interval 18.0 to 43.6
|
—
|
|
Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 2 Years After Toddler Dose
6B (n= 56, 48)
|
35.7 percentage of participants
Interval 23.4 to 49.6
|
35.4 percentage of participants
Interval 22.2 to 50.5
|
—
|
|
Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 2 Years After Toddler Dose
9V (n= 50, 55)
|
60.0 percentage of participants
Interval 45.2 to 73.6
|
52.7 percentage of participants
Interval 38.8 to 66.3
|
—
|
|
Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 2 Years After Toddler Dose
14 (n= 49, 45)
|
81.6 percentage of participants
Interval 68.0 to 91.2
|
84.4 percentage of participants
Interval 70.5 to 93.5
|
—
|
|
Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 2 Years After Toddler Dose
18C (n= 56, 56)
|
21.4 percentage of participants
Interval 11.6 to 34.4
|
39.3 percentage of participants
Interval 26.5 to 53.2
|
—
|
|
Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 2 Years After Toddler Dose
19F (n= 60, 58)
|
25.0 percentage of participants
Interval 14.7 to 37.9
|
29.3 percentage of participants
Interval 18.1 to 42.7
|
—
|
|
Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 2 Years After Toddler Dose
23F (n= 58, 59)
|
53.4 percentage of participants
Interval 39.9 to 66.7
|
74.6 percentage of participants
Interval 61.6 to 85.0
|
—
|
|
Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 2 Years After Toddler Dose
1 (n= 70, 68)
|
8.6 percentage of participants
Interval 3.2 to 17.7
|
2.9 percentage of participants
Interval 0.4 to 10.2
|
—
|
|
Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 2 Years After Toddler Dose
19A (n= 68, 67)
|
45.6 percentage of participants
Interval 33.5 to 58.1
|
67.2 percentage of participants
Interval 54.6 to 78.2
|
—
|
Adverse Events
13vPnC Group 1 (Preterm Infant) - Infant Series
Serious events: 14 serious events
Other events: 98 other events
Deaths: 0 deaths
13vPnC Group 2 (Term Infant) - Infant Series
Serious events: 5 serious events
Other events: 99 other events
Deaths: 0 deaths
13vPnC Group 1 (Preterm Infant) - After Infant Series
Serious events: 8 serious events
Other events: 13 other events
Deaths: 0 deaths
13vPnC Group 2 (Term Infant) - After Infant Series
Serious events: 9 serious events
Other events: 11 other events
Deaths: 0 deaths
13vPnC Group 1 (Preterm Infant) - Toddler Dose
Serious events: 2 serious events
Other events: 93 other events
Deaths: 0 deaths
13vPnC Group 2 (Term Infant) - Toddler Dose
Serious events: 1 serious events
Other events: 92 other events
Deaths: 0 deaths
13vPnC Group 1 (Preterm Infant) - 1 Year Follow-up
Serious events: 13 serious events
Other events: 2 other events
Deaths: 0 deaths
13vPnC Group 2 (Term Infant) - 1 Year Follow-up
Serious events: 8 serious events
Other events: 0 other events
Deaths: 0 deaths
13vPnC Group 1 (Preterm Infant) - 2 Year Follow-up
Serious events: 6 serious events
Other events: 1 other events
Deaths: 0 deaths
13vPnC Group 2 (Term Infant) - 2 Year Follow-up
Serious events: 8 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
13vPnC Group 1 (Preterm Infant) - Infant Series
n=100 participants at risk
Preterm infant participants (GA \<37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3 and 4 months of age (infant series), assessed from Infant Dose 1 through the blood draw 1 month after Infant Dose 3.
|
13vPnC Group 2 (Term Infant) - Infant Series
n=100 participants at risk
Term infant participants (GA \>=37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series), assessed from Infant Dose 1 through the blood draw 1 month after Infant Dose 3.
|
13vPnC Group 1 (Preterm Infant) - After Infant Series
n=100 participants at risk
Preterm infant participants (GA \<37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3 and 4 months of age (infant series), assessed from blood draw 1 month after infant Dose 3 to before toddler dose.
|
13vPnC Group 2 (Term Infant) - After Infant Series
n=100 participants at risk
Term infant participants (GA \>=37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series), assessed from blood draw 1 month after infant Dose 3 to before toddler dose.
|
13vPnC Group 1 (Preterm Infant) - Toddler Dose
n=99 participants at risk
Preterm infant participants (GA \<37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and 12 months of age (toddler dose), assessed from the toddler dose through the blood draw 1 month after toddler dose.
|
13vPnC Group 2 (Term Infant) - Toddler Dose
n=97 participants at risk
Term infant participants (GA \>=37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and 12 months of age (toddler dose), assessed from the toddler dose through the blood draw 1 month after toddler dose.
|
13vPnC Group 1 (Preterm Infant) - 1 Year Follow-up
n=99 participants at risk
Preterm infant participants (GA \<37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and 12 months of age (toddler dose), assessed from blood draw 1 month after the toddler dose to 1-year follow-up.
|
13vPnC Group 2 (Term Infant) - 1 Year Follow-up
n=97 participants at risk
Term infant participants (GA \>=37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and 12 months of age (toddler dose), assessed from blood draw 1 month after the toddler dose to 1-year follow-up.
|
13vPnC Group 1 (Preterm Infant) - 2 Year Follow-up
n=88 participants at risk
Preterm infant participants (GA \<37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and 12 months of age (toddler dose), assessed from 1-year follow-up after toddler dose to 2-year follow-up after toddler dose.
|
13vPnC Group 2 (Term Infant) - 2 Year Follow-up
n=88 participants at risk
Term infant participants (GA \>=37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and 12 months of age (toddler dose), assessed from 1-year follow-up after toddler dose to 2-year follow-up after toddler dose.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Inguinal hernia, obstructive
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.0%
1/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.0%
2/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.0%
1/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.0%
1/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.0%
1/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.0%
1/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Gastrointestinal disorders
Intussusception
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
2.1%
2/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.0%
1/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Adenoviral upper respiratory infection
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.0%
1/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Bronchiolitis
|
4.0%
4/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
2.0%
2/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.0%
1/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.0%
1/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.0%
1/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.0%
1/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
2.0%
2/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
2.0%
2/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.1%
1/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.1%
1/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Gastroenteritis
|
1.0%
1/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
2.0%
2/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.0%
1/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Pneumonia
|
2.0%
2/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.0%
1/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
3.0%
3/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
4.0%
4/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
2.3%
2/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Pneumonia respiratory syncytial viral
|
2.0%
2/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.0%
1/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.0%
1/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Pyelonephritis acute
|
1.0%
1/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Respiratory syncytial virus bronchiolitis
|
2.0%
2/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.0%
1/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.0%
2/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.0%
1/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
3.0%
3/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.0%
1/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.1%
1/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Human herpesvirus 6 infection
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.0%
1/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Viral rash
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.0%
1/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Gastroenteritis rotavirus
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.0%
1/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.0%
1/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
2.0%
2/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.0%
1/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Pneumonia mycoplasmal
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.0%
1/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.0%
1/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.1%
1/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Encephalitis viral
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.1%
1/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.1%
1/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Meningitis viral
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.1%
1/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.1%
1/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Viral infection
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.1%
1/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.0%
1/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Reproductive system and breast disorders
Ovarian cyst torsion
|
1.0%
1/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
1.0%
1/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Nervous system disorders
Febrile convulsion
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.0%
1/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.0%
1/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.1%
1/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.1%
1/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.0%
1/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.0%
1/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.1%
1/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Congenital, familial and genetic disorders
Hip dysplasia
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.0%
1/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Congenital, familial and genetic disorders
Cerebral palsy
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
2.3%
2/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Psychiatric disorders
Autism spectrum disorder
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.1%
1/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Musculoskeletal and connective tissue disorders
Arthritis reactive
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.1%
1/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.0%
1/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.1%
1/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.0%
1/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.0%
1/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Surgical and medical procedures
CSF shunt operation
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.0%
1/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
Other adverse events
| Measure |
13vPnC Group 1 (Preterm Infant) - Infant Series
n=100 participants at risk
Preterm infant participants (GA \<37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3 and 4 months of age (infant series), assessed from Infant Dose 1 through the blood draw 1 month after Infant Dose 3.
|
13vPnC Group 2 (Term Infant) - Infant Series
n=100 participants at risk
Term infant participants (GA \>=37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series), assessed from Infant Dose 1 through the blood draw 1 month after Infant Dose 3.
|
13vPnC Group 1 (Preterm Infant) - After Infant Series
n=100 participants at risk
Preterm infant participants (GA \<37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3 and 4 months of age (infant series), assessed from blood draw 1 month after infant Dose 3 to before toddler dose.
|
13vPnC Group 2 (Term Infant) - After Infant Series
n=100 participants at risk
Term infant participants (GA \>=37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series), assessed from blood draw 1 month after infant Dose 3 to before toddler dose.
|
13vPnC Group 1 (Preterm Infant) - Toddler Dose
n=99 participants at risk
Preterm infant participants (GA \<37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and 12 months of age (toddler dose), assessed from the toddler dose through the blood draw 1 month after toddler dose.
|
13vPnC Group 2 (Term Infant) - Toddler Dose
n=97 participants at risk
Term infant participants (GA \>=37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and 12 months of age (toddler dose), assessed from the toddler dose through the blood draw 1 month after toddler dose.
|
13vPnC Group 1 (Preterm Infant) - 1 Year Follow-up
n=99 participants at risk
Preterm infant participants (GA \<37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and 12 months of age (toddler dose), assessed from blood draw 1 month after the toddler dose to 1-year follow-up.
|
13vPnC Group 2 (Term Infant) - 1 Year Follow-up
n=97 participants at risk
Term infant participants (GA \>=37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and 12 months of age (toddler dose), assessed from blood draw 1 month after the toddler dose to 1-year follow-up.
|
13vPnC Group 1 (Preterm Infant) - 2 Year Follow-up
n=88 participants at risk
Preterm infant participants (GA \<37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and 12 months of age (toddler dose), assessed from 1-year follow-up after toddler dose to 2-year follow-up after toddler dose.
|
13vPnC Group 2 (Term Infant) - 2 Year Follow-up
n=88 participants at risk
Term infant participants (GA \>=37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and 12 months of age (toddler dose), assessed from 1-year follow-up after toddler dose to 2-year follow-up after toddler dose.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.0%
1/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Congenital, familial and genetic disorders
Craniotabes
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.0%
1/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.0%
1/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Eye disorders
Conjunctivitis
|
2.0%
2/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Eye disorders
Eye discharge
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.0%
1/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.0%
2/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
1.0%
1/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.0%
1/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Gastrointestinal disorders
Constipation
|
2.0%
2/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
3.0%
3/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.0%
1/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.0%
1/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
2.0%
2/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
2.1%
2/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Gastrointestinal disorders
Dyspepsia
|
2.0%
2/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
3.0%
3/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.0%
1/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.0%
1/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Gastrointestinal disorders
Infantile colic
|
1.0%
1/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Gastrointestinal disorders
Umbilical hernia
|
2.0%
2/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
General disorders
Injection site erythema
|
1.0%
1/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
General disorders
Injection site swelling
|
1.0%
1/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
General disorders
Irritability
|
5.0%
5/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
3.0%
3/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
General disorders
Pyrexia
|
2.0%
2/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
4.0%
4/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.0%
1/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.0%
1/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.0%
1/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.0%
1/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Immune system disorders
Food allergy
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
2.0%
2/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.0%
1/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Immune system disorders
Milk allergy
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.0%
1/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.0%
1/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Bronchiolitis
|
7.0%
7/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
6.0%
6/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.0%
1/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.0%
1/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Bronchitis
|
5.0%
5/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.0%
1/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
3.0%
3/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
3.0%
3/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
2.1%
2/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Ear infection
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.0%
1/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Exanthema subitum
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.0%
1/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
2.0%
2/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
2.1%
2/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
6.0%
6/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.0%
1/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
3.0%
3/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
2.1%
2/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Influenza
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.0%
1/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
2.0%
2/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.0%
1/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Nasopharyngitis
|
6.0%
6/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
5.0%
5/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
2.0%
2/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
6.1%
6/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
4.1%
4/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.0%
1/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Otitis media
|
1.0%
1/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.0%
1/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
2.1%
2/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Otitis media acute
|
1.0%
1/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.0%
1/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.0%
1/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
2.1%
2/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Pharyngitis
|
1.0%
1/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.0%
1/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.0%
1/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
3.0%
3/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.0%
1/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Pneumonia
|
1.0%
1/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.0%
1/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.0%
1/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.0%
1/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Respiratory tract infection
|
8.0%
8/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
9.0%
9/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
4.0%
4/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
3.0%
3/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.0%
1/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Respiratory tract infection bacterial
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.0%
1/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Respiratory tract infection viral
|
1.0%
1/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Rhinitis
|
5.0%
5/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
4.0%
4/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
2.0%
2/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.0%
1/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Upper respiratory tract infection
|
8.0%
8/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
10.0%
10/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.0%
1/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
5.1%
5/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
4.1%
4/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Urinary tract infection
|
1.0%
1/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.0%
1/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.0%
1/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Viral infection
|
1.0%
1/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.0%
1/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.0%
1/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Viral rash
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.0%
1/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.0%
1/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
2.0%
2/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Investigations
Cardiac murmur
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.0%
1/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.0%
1/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
3.0%
3/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
2.0%
2/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.0%
1/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.0%
1/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Nervous system disorders
Hypersomnia
|
3.0%
3/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Nervous system disorders
Hypotonia
|
1.0%
1/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Nervous system disorders
Subdural hygroma
|
1.0%
1/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic respiratory disease
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.0%
1/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.0%
1/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
2.0%
2/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.0%
1/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
1.0%
1/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
2.0%
2/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
2.0%
2/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
1.0%
1/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
1.0%
1/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
1.0%
1/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.0%
1/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.0%
1/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.0%
1/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.1%
1/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
2.0%
2/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Congenital, familial and genetic disorders
Beckwith-Wiedemann syndrome
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.0%
1/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Immune system disorders
Allergy to arthropod sting
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.0%
1/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.0%
1/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Gastrointestinal disorders
Teething
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
2.1%
2/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.0%
1/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Herpangina
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.0%
1/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
2.1%
2/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Nervous system disorders
Febrile convulsion
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.0%
1/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
General disorders
Developmental delay
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/100 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.0%
1/99 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/97 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.1%
1/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Skin and subcutaneous tissue disorders
Tenderness- Any
|
39.0%
32/82 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
28.6%
24/84 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Skin and subcutaneous tissue disorders
Tenderness- Mild
|
35.8%
29/81 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
26.2%
22/84 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Skin and subcutaneous tissue disorders
Tenderness- Moderate
|
9.3%
7/75 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
5.1%
4/78 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Skin and subcutaneous tissue disorders
Tenderness- Severe
|
0.00%
0/73 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/77 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Skin and subcutaneous tissue disorders
Swelling- Any
|
30.1%
25/83 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
41.2%
35/85 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Skin and subcutaneous tissue disorders
Swelling- Mild
|
26.8%
22/82 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
41.2%
35/85 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Skin and subcutaneous tissue disorders
Swelling- Moderate
|
5.3%
4/75 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
5.1%
4/79 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Skin and subcutaneous tissue disorders
Swelling- Severe
|
0.00%
0/73 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/77 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Skin and subcutaneous tissue disorders
Redness- Any
|
32.9%
27/82 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
46.0%
40/87 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Skin and subcutaneous tissue disorders
Redness- Mild
|
32.9%
27/82 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
46.0%
40/87 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Skin and subcutaneous tissue disorders
Redness- Moderate
|
1.4%
1/74 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
3.8%
3/79 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
Skin and subcutaneous tissue disorders
Redness- Severe
|
0.00%
0/73 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/77 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
General disorders
Fever >=38 degrees C
|
27.8%
22/79 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
30.9%
25/81 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
General disorders
Fever >=38 degrees C, =<39 degrees C
|
26.9%
21/78 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
30.9%
25/81 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
General disorders
Fever >=39 degrees C, =<40 degrees C
|
1.3%
1/75 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
2.6%
2/78 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
General disorders
Fever >40 degrees C
|
0.00%
0/74 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/77 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
0.00%
0/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
General disorders
Decreased Appetite- Any
|
48.8%
40/82 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
47.6%
40/84 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
General disorders
Decreased Appetite- Mild
|
36.6%
30/82 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
46.4%
39/84 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
General disorders
Decreased Appetite- Moderate
|
17.6%
13/74 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
16.5%
13/79 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
General disorders
Decreased Appetite- Severe
|
1.4%
1/74 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.3%
1/77 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
General disorders
Increased Sleep- Any
|
52.3%
46/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
58.0%
51/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
General disorders
Increased Sleep- Mild
|
48.9%
43/88 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
51.7%
45/87 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
General disorders
Increased Sleep- Moderate
|
16.9%
13/77 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
20.0%
16/80 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
General disorders
Increased Sleep- Severe
|
1.4%
1/73 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
1.3%
1/77 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
General disorders
Irritability or Decreased Sleep- Any
|
79.3%
73/92 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
81.1%
77/95 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
General disorders
Irritability or Decreased Sleep- Mild
|
72.2%
65/90 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
74.7%
68/91 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
General disorders
Irritability or Decreased Sleep-Moderate
|
33.8%
27/80 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
35.6%
31/87 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
General disorders
Irritability or Decreased Sleep- Severe
|
6.8%
5/74 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
6.4%
5/78 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
|
General disorders
Use of Antipyretic Medication
|
40.5%
34/84 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
38.3%
31/81 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
—
0/0 • AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER