Trial Outcomes & Findings for Study Evaluating the Impact of the 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in Alaskan Native Children. (NCT NCT00743652)
NCT ID: NCT00743652
Last Updated: 2012-03-15
Results Overview
Percentage of participants in 13vPnC Groups 1, 2 and 3 achieving predefined antibody threshold ≥0.35 mcg/mL along with the corresponding 95% 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) are presented. Exact 2-sided CI based upon the observed proportion of participants.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
373 participants
Primary outcome timeframe
28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3.
Results posted on
2012-03-15
Participant Flow
Blood sample was optional for subjects living in the Bethel area. Active vaccination stopped when 13-valent pneumococcal conjugate vaccine (13vPnC) was commercially available in Alaska. Study ended after a 6-month follow-up for safety following the last vaccination.
Participant milestones
| Measure |
13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose)
Participants 6 weeks to less than (\<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (\>) 12 months of age (toddler dose), at least 60 days after last infant dose.
|
13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)
Participants \<12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at \>12 months of age (toddler dose), at least 60 days after last infant dose.
|
13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)
Participants \<12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at \>12 months of age (toddler dose), at least 60 days after last infant dose.
|
13vPnC Group 4 (2 Catch-Up Doses)
Participants greater than or equal to (≥) 12 months to \<2 years of age received 2 single IM 0.5 mL doses of 13vPnC at least 60 days apart.
|
13vPnC Group 5 (1 Catch-Up Dose)
Participants ≥2 years to \<5 years of age received a single IM 0.5 mL dose of 13vPnC.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
151
|
51
|
25
|
67
|
79
|
|
Overall Study
Vaccinated Dose 1
|
151
|
51
|
25
|
66
|
79
|
|
Overall Study
Vaccinated Dose 2
|
112
|
41
|
0
|
49
|
0
|
|
Overall Study
Vaccinated Dose 3
|
74
|
0
|
0
|
0
|
0
|
|
Overall Study
Toddler Dose
|
15
|
23
|
16
|
0
|
0
|
|
Overall Study
COMPLETED
|
141
|
48
|
23
|
63
|
79
|
|
Overall Study
NOT COMPLETED
|
10
|
3
|
2
|
4
|
0
|
Reasons for withdrawal
| Measure |
13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose)
Participants 6 weeks to less than (\<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (\>) 12 months of age (toddler dose), at least 60 days after last infant dose.
|
13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)
Participants \<12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at \>12 months of age (toddler dose), at least 60 days after last infant dose.
|
13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)
Participants \<12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at \>12 months of age (toddler dose), at least 60 days after last infant dose.
|
13vPnC Group 4 (2 Catch-Up Doses)
Participants greater than or equal to (≥) 12 months to \<2 years of age received 2 single IM 0.5 mL doses of 13vPnC at least 60 days apart.
|
13vPnC Group 5 (1 Catch-Up Dose)
Participants ≥2 years to \<5 years of age received a single IM 0.5 mL dose of 13vPnC.
|
|---|---|---|---|---|---|
|
Overall Study
Parent/Legal Guardian Request
|
3
|
2
|
2
|
2
|
0
|
|
Overall Study
Adverse Event
|
3
|
0
|
0
|
0
|
0
|
|
Overall Study
Death
|
2
|
0
|
0
|
0
|
0
|
|
Overall Study
Investigator Request
|
0
|
0
|
0
|
2
|
0
|
|
Overall Study
Other
|
1
|
1
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Study Evaluating the Impact of the 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in Alaskan Native Children.
Baseline characteristics by cohort
| Measure |
13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose)
n=151 Participants
Participants 6 weeks to less than (\<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (\>) 12 months of age (toddler dose), at least 60 days after last infant dose.
|
13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)
n=51 Participants
Participants \<12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at \>12 months of age (toddler dose), at least 60 days after last infant dose.
|
13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)
n=25 Participants
Participants \<12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at \>12 months of age (toddler dose), at least 60 days after last infant dose.
|
13vPnC Group 4 (2 Catch-Up Doses)
n=67 Participants
Participants greater than or equal to (≥) 12 months to \<2 years of age received 2 single IM 0.5 mL doses of 13vPnC at least 60 days apart.
|
13vPnC Group 5 (1 Catch-Up Dose)
n=79 Participants
Participants ≥2 years to \<5 years of age received a single IM 0.5 mL dose of 13vPnC.
|
Total
n=373 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Customized
|
1.4 Months
STANDARD_DEVIATION 0.6 • n=5 Participants
|
4.4 Months
STANDARD_DEVIATION 0.8 • n=7 Participants
|
7.1 Months
STANDARD_DEVIATION 1.6 • n=5 Participants
|
15.2 Months
STANDARD_DEVIATION 3.4 • n=4 Participants
|
40.1 Months
STANDARD_DEVIATION 11.1 • n=21 Participants
|
12.9 Months
STANDARD_DEVIATION 15.9 • n=8 Participants
|
|
Sex: Female, Male
Female
|
73 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
47 Participants
n=21 Participants
|
190 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
78 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
183 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3.Population: Evaluable immunogenicity population: received treatments as randomized at all expected doses, blood drawn within specified timeframes, at least 1 valid and determinate assay result for proposed analysis, and no major protocol violations. N=number of participants with a determinate IgG antibody concentration to the given serotype.
Percentage of participants in 13vPnC Groups 1, 2 and 3 achieving predefined antibody threshold ≥0.35 mcg/mL along with the corresponding 95% 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) are presented. Exact 2-sided CI based upon the observed proportion of participants.
Outcome measures
| Measure |
13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)
n=3 Participants
Participants \<12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at \>12 months of age (toddler dose), at least 60 days after last infant dose.
|
13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose)
n=11 Participants
Participants 6 weeks to less than (\<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (\>) 12 months of age (toddler dose), at least 60 days after last infant dose.
|
13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)
n=6 Participants
Participants \<12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at \>12 months of age (toddler dose), at least 60 days after last infant dose.
|
|---|---|---|---|
|
Percentage of Participants Achieving Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Level ≥0.35 Micrograms Per Milliliter (Mcg/mL) 1 Month After the Infant Series
Additional serotype - serotype 3
|
100.0 Percentage of Participants
Interval 29.2 to 100.0
|
90.9 Percentage of Participants
Interval 58.7 to 99.8
|
100.0 Percentage of Participants
Interval 54.1 to 100.0
|
|
Percentage of Participants Achieving Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Level ≥0.35 Micrograms Per Milliliter (Mcg/mL) 1 Month After the Infant Series
Common serotypes - serotype 4
|
100.0 Percentage of Participants
Interval 29.2 to 100.0
|
100.0 Percentage of Participants
Interval 71.5 to 100.0
|
100.0 Percentage of Participants
Interval 54.1 to 100.0
|
|
Percentage of Participants Achieving Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Level ≥0.35 Micrograms Per Milliliter (Mcg/mL) 1 Month After the Infant Series
Common serotypes - serotype 6B
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
100.0 Percentage of Participants
Interval 71.5 to 100.0
|
83.3 Percentage of Participants
Interval 35.9 to 99.6
|
|
Percentage of Participants Achieving Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Level ≥0.35 Micrograms Per Milliliter (Mcg/mL) 1 Month After the Infant Series
Common serotypes - serotype 9V
|
100.0 Percentage of Participants
Interval 29.2 to 100.0
|
100.0 Percentage of Participants
Interval 71.5 to 100.0
|
83.3 Percentage of Participants
Interval 35.9 to 99.6
|
|
Percentage of Participants Achieving Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Level ≥0.35 Micrograms Per Milliliter (Mcg/mL) 1 Month After the Infant Series
Common serotypes - serotype 14
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
90.9 Percentage of Participants
Interval 58.7 to 99.8
|
100.0 Percentage of Participants
Interval 54.1 to 100.0
|
|
Percentage of Participants Achieving Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Level ≥0.35 Micrograms Per Milliliter (Mcg/mL) 1 Month After the Infant Series
Common serotype - serotype 18C
|
100.0 Percentage of Participants
Interval 29.2 to 100.0
|
100.0 Percentage of Participants
Interval 71.5 to 100.0
|
100.0 Percentage of Participants
Interval 54.1 to 100.0
|
|
Percentage of Participants Achieving Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Level ≥0.35 Micrograms Per Milliliter (Mcg/mL) 1 Month After the Infant Series
Common serotype - serotype 19F
|
100.0 Percentage of Participants
Interval 29.2 to 100.0
|
100.0 Percentage of Participants
Interval 71.5 to 100.0
|
100.0 Percentage of Participants
Interval 54.1 to 100.0
|
|
Percentage of Participants Achieving Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Level ≥0.35 Micrograms Per Milliliter (Mcg/mL) 1 Month After the Infant Series
Common serotype - serotype 23F
|
100.0 Percentage of Participants
Interval 29.2 to 100.0
|
90.9 Percentage of Participants
Interval 58.7 to 99.8
|
83.3 Percentage of Participants
Interval 35.9 to 99.6
|
|
Percentage of Participants Achieving Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Level ≥0.35 Micrograms Per Milliliter (Mcg/mL) 1 Month After the Infant Series
Additional serotype - serotype 1
|
100.0 Percentage of Participants
Interval 29.2 to 100.0
|
100.0 Percentage of Participants
Interval 71.5 to 100.0
|
100.0 Percentage of Participants
Interval 54.1 to 100.0
|
|
Percentage of Participants Achieving Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Level ≥0.35 Micrograms Per Milliliter (Mcg/mL) 1 Month After the Infant Series
Additional serotype - serotype 5
|
100.0 Percentage of Participants
Interval 29.2 to 100.0
|
100.0 Percentage of Participants
Interval 71.5 to 100.0
|
100.0 Percentage of Participants
Interval 54.1 to 100.0
|
|
Percentage of Participants Achieving Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Level ≥0.35 Micrograms Per Milliliter (Mcg/mL) 1 Month After the Infant Series
Additional serotype - serotype 6A
|
100.0 Percentage of Participants
Interval 29.2 to 100.0
|
90.9 Percentage of Participants
Interval 58.7 to 99.8
|
100.0 Percentage of Participants
Interval 54.1 to 100.0
|
|
Percentage of Participants Achieving Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Level ≥0.35 Micrograms Per Milliliter (Mcg/mL) 1 Month After the Infant Series
Additional serotype - serotype 7F
|
100.0 Percentage of Participants
Interval 29.2 to 100.0
|
100.0 Percentage of Participants
Interval 71.5 to 100.0
|
100.0 Percentage of Participants
Interval 54.1 to 100.0
|
|
Percentage of Participants Achieving Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Level ≥0.35 Micrograms Per Milliliter (Mcg/mL) 1 Month After the Infant Series
Additional serotype - serotype 19A
|
100.0 Percentage of Participants
Interval 29.2 to 100.0
|
100.0 Percentage of Participants
Interval 71.5 to 100.0
|
100.0 Percentage of Participants
Interval 54.1 to 100.0
|
PRIMARY outcome
Timeframe: 28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, and after vaccination 2 for Group 3.Population: Evaluable immunogenicity population. N=number of participants with a determinate IgG antibody concentration to the given serotype.
Percentage of participants in 13vPnC Groups 1, 2, and 3 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) are presented. Exact 2-sided CI based upon the observed proportion of participants.
Outcome measures
| Measure |
13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)
n=2 Participants
Participants \<12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at \>12 months of age (toddler dose), at least 60 days after last infant dose.
|
13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose)
n=2 Participants
Participants 6 weeks to less than (\<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (\>) 12 months of age (toddler dose), at least 60 days after last infant dose.
|
13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)
n=6 Participants
Participants \<12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at \>12 months of age (toddler dose), at least 60 days after last infant dose.
|
|---|---|---|---|
|
Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Toddler Dose
Common serotypes - serotype 4
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
100.0 Percentage of Participants
Interval 54.1 to 100.0
|
|
Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Toddler Dose
Common serotypes - serotype 6B
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
100.0 Percentage of Participants
Interval 54.1 to 100.0
|
|
Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Toddler Dose
Common serotypes - serotype 9V
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
100.0 Percentage of Participants
Interval 54.1 to 100.0
|
|
Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Toddler Dose
Common serotypes - serotype 14
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
100.0 Percentage of Participants
Interval 54.1 to 100.0
|
|
Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Toddler Dose
Common serotype - serotype 18C
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
100.0 Percentage of Participants
Interval 54.1 to 100.0
|
|
Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Toddler Dose
Common serotype - serotype 19F
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
100.0 Percentage of Participants
Interval 54.1 to 100.0
|
|
Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Toddler Dose
Common serotype - serotype 23F
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
100.0 Percentage of Participants
Interval 54.1 to 100.0
|
|
Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Toddler Dose
Additional serotype - serotype 1
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
100.0 Percentage of Participants
Interval 54.1 to 100.0
|
|
Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Toddler Dose
Additional serotype - serotype 3
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
100.0 Percentage of Participants
Interval 54.1 to 100.0
|
|
Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Toddler Dose
Additional serotype - serotype 5
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
100.0 Percentage of Participants
Interval 54.1 to 100.0
|
|
Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Toddler Dose
Additional serotype - serotype 6A
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
100.0 Percentage of Participants
Interval 54.1 to 100.0
|
|
Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Toddler Dose
Additional serotype - serotype 7F
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
100.0 Percentage of Participants
Interval 54.1 to 100.0
|
|
Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Toddler Dose
Additional serotype - serotype 19A
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
100.0 Percentage of Participants
Interval 54.1 to 100.0
|
PRIMARY outcome
Timeframe: 28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5.Population: Evaluable immunogenicity population. N=number of participants with a determinate IgG antibody concentration to the given serotype.
Percentage of participants in 13vPnC Groups 4 and 5 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) are presented. Exact 2-sided CI based upon the observed proportion of participants.
Outcome measures
| Measure |
13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)
Participants \<12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at \>12 months of age (toddler dose), at least 60 days after last infant dose.
|
13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose)
n=4 Participants
Participants 6 weeks to less than (\<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (\>) 12 months of age (toddler dose), at least 60 days after last infant dose.
|
13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)
n=9 Participants
Participants \<12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at \>12 months of age (toddler dose), at least 60 days after last infant dose.
|
|---|---|---|---|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Relevant Catch-Up Dose
Common serotype - serotype 23F
|
—
|
100.0 Percentage of Participants
Interval 39.8 to 100.0
|
100.0 Percentage of Participants
Interval 66.4 to 100.0
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Relevant Catch-Up Dose
Common serotypes - serotype 4
|
—
|
100.0 Percentage of Participants
Interval 39.8 to 100.0
|
100.0 Percentage of Participants
Interval 66.4 to 100.0
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Relevant Catch-Up Dose
Common serotypes - serotype 6B
|
—
|
100.0 Percentage of Participants
Interval 39.8 to 100.0
|
100.0 Percentage of Participants
Interval 66.4 to 100.0
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Relevant Catch-Up Dose
Common serotypes - serotype 9V
|
—
|
100.0 Percentage of Participants
Interval 39.8 to 100.0
|
100.0 Percentage of Participants
Interval 66.4 to 100.0
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Relevant Catch-Up Dose
Common serotypes - serotype 14
|
—
|
100.0 Percentage of Participants
Interval 39.8 to 100.0
|
100.0 Percentage of Participants
Interval 66.4 to 100.0
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Relevant Catch-Up Dose
Common serotype - serotype 18C
|
—
|
100.0 Percentage of Participants
Interval 39.8 to 100.0
|
100.0 Percentage of Participants
Interval 66.4 to 100.0
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Relevant Catch-Up Dose
Common serotype - serotype 19F
|
—
|
100.0 Percentage of Participants
Interval 39.8 to 100.0
|
100.0 Percentage of Participants
Interval 66.4 to 100.0
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Relevant Catch-Up Dose
Additional serotype - serotype 1
|
—
|
100.0 Percentage of Participants
Interval 39.8 to 100.0
|
100.0 Percentage of Participants
Interval 66.4 to 100.0
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Relevant Catch-Up Dose
Additional serotype - serotype 3
|
—
|
100.0 Percentage of Participants
Interval 39.8 to 100.0
|
100.0 Percentage of Participants
Interval 66.4 to 100.0
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Relevant Catch-Up Dose
Additional serotype - serotype 5
|
—
|
100.0 Percentage of Participants
Interval 39.8 to 100.0
|
100.0 Percentage of Participants
Interval 66.4 to 100.0
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Relevant Catch-Up Dose
Additional serotype - serotype 6A
|
—
|
100.0 Percentage of Participants
Interval 39.8 to 100.0
|
100.0 Percentage of Participants
Interval 66.4 to 100.0
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Relevant Catch-Up Dose
Additional serotype - serotype 7F
|
—
|
100.0 Percentage of Participants
Interval 39.8 to 100.0
|
100.0 Percentage of Participants
Interval 66.4 to 100.0
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Relevant Catch-Up Dose
Additional serotype - serotype 19A
|
—
|
100.0 Percentage of Participants
Interval 39.8 to 100.0
|
100.0 Percentage of Participants
Interval 66.4 to 100.0
|
SECONDARY outcome
Timeframe: 28 to 56 days before vaccination 2 for Group 4, and before the single vaccination in Group 5.Population: Evaluable immunogenicity population. N=number of participants with a determinate IgG antibody concentration to the given serotype.
Percentage of participants in 13vPnC Groups 4 and 5 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) are presented. Exact 2-sided CI based upon the observed proportion of participants.
Outcome measures
| Measure |
13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)
Participants \<12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at \>12 months of age (toddler dose), at least 60 days after last infant dose.
|
13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose)
n=4 Participants
Participants 6 weeks to less than (\<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (\>) 12 months of age (toddler dose), at least 60 days after last infant dose.
|
13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)
n=9 Participants
Participants \<12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at \>12 months of age (toddler dose), at least 60 days after last infant dose.
|
|---|---|---|---|
|
Percentage of Participants Achieving Serum IgG Antibody Level ≥0.35 Mcg/mL Prior to Vaccination With 13vPnC (Groups 4 and 5 Only)
Common serotypes - serotype 4
|
—
|
50.0 Percentage of Participants
Interval 6.8 to 93.2
|
50.0 Percentage of Participants
Interval 15.7 to 84.3
|
|
Percentage of Participants Achieving Serum IgG Antibody Level ≥0.35 Mcg/mL Prior to Vaccination With 13vPnC (Groups 4 and 5 Only)
Common serotypes - serotype 6B
|
—
|
100.0 Percentage of Participants
Interval 39.8 to 100.0
|
88.9 Percentage of Participants
Interval 51.8 to 99.7
|
|
Percentage of Participants Achieving Serum IgG Antibody Level ≥0.35 Mcg/mL Prior to Vaccination With 13vPnC (Groups 4 and 5 Only)
Common serotypes - serotype 9V
|
—
|
100.0 Percentage of Participants
Interval 39.8 to 100.0
|
66.7 Percentage of Participants
Interval 29.9 to 92.5
|
|
Percentage of Participants Achieving Serum IgG Antibody Level ≥0.35 Mcg/mL Prior to Vaccination With 13vPnC (Groups 4 and 5 Only)
Common serotypes - serotype 14
|
—
|
100.0 Percentage of Participants
Interval 29.2 to 100.0
|
88.9 Percentage of Participants
Interval 51.8 to 99.7
|
|
Percentage of Participants Achieving Serum IgG Antibody Level ≥0.35 Mcg/mL Prior to Vaccination With 13vPnC (Groups 4 and 5 Only)
Common serotype - serotype 18C
|
—
|
75.0 Percentage of Participants
Interval 19.4 to 99.4
|
33.3 Percentage of Participants
Interval 7.5 to 70.1
|
|
Percentage of Participants Achieving Serum IgG Antibody Level ≥0.35 Mcg/mL Prior to Vaccination With 13vPnC (Groups 4 and 5 Only)
Common serotype - serotype 19F
|
—
|
100.0 Percentage of Participants
Interval 39.8 to 100.0
|
88.9 Percentage of Participants
Interval 51.8 to 99.7
|
|
Percentage of Participants Achieving Serum IgG Antibody Level ≥0.35 Mcg/mL Prior to Vaccination With 13vPnC (Groups 4 and 5 Only)
Common serotype - serotype 23F
|
—
|
100.0 Percentage of Participants
Interval 39.8 to 100.0
|
88.9 Percentage of Participants
Interval 51.8 to 99.7
|
|
Percentage of Participants Achieving Serum IgG Antibody Level ≥0.35 Mcg/mL Prior to Vaccination With 13vPnC (Groups 4 and 5 Only)
Additional serotype - serotype 1
|
—
|
0.0 Percentage of Participants
Interval 0.0 to 60.2
|
12.5 Percentage of Participants
Interval 0.3 to 52.7
|
|
Percentage of Participants Achieving Serum IgG Antibody Level ≥0.35 Mcg/mL Prior to Vaccination With 13vPnC (Groups 4 and 5 Only)
Additional serotype - serotype 3
|
—
|
0.0 Percentage of Participants
Interval 0.0 to 60.2
|
37.5 Percentage of Participants
Interval 8.5 to 75.5
|
|
Percentage of Participants Achieving Serum IgG Antibody Level ≥0.35 Mcg/mL Prior to Vaccination With 13vPnC (Groups 4 and 5 Only)
Additional serotype - serotype 5
|
—
|
50.0 Percentage of Participants
Interval 6.8 to 93.2
|
100.0 Percentage of Participants
Interval 66.4 to 100.0
|
|
Percentage of Participants Achieving Serum IgG Antibody Level ≥0.35 Mcg/mL Prior to Vaccination With 13vPnC (Groups 4 and 5 Only)
Additional serotype - serotype 6A
|
—
|
100.0 Percentage of Participants
Interval 39.8 to 100.0
|
88.9 Percentage of Participants
Interval 51.8 to 99.7
|
|
Percentage of Participants Achieving Serum IgG Antibody Level ≥0.35 Mcg/mL Prior to Vaccination With 13vPnC (Groups 4 and 5 Only)
Additional serotype - serotype 7F
|
—
|
0.0 Percentage of Participants
Interval 0.0 to 60.2
|
33.3 Percentage of Participants
Interval 7.5 to 70.1
|
|
Percentage of Participants Achieving Serum IgG Antibody Level ≥0.35 Mcg/mL Prior to Vaccination With 13vPnC (Groups 4 and 5 Only)
Additional serotype - serotype 19A
|
—
|
100.0 Percentage of Participants
Interval 39.8 to 100.0
|
88.9 Percentage of Participants
Interval 51.8 to 99.7
|
SECONDARY outcome
Timeframe: 28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3.Population: Evaluable immunogenicity population. N=number of participants with a determinate IgG antibody concentration to the given serotype.
Percentage of participants in 13vPnC Groups 1, 2, and 3 achieving predefined antibody threshold ≥1.0 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) are presented. Exact 2-sided CI based upon the observed proportion of participants.
Outcome measures
| Measure |
13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)
n=3 Participants
Participants \<12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at \>12 months of age (toddler dose), at least 60 days after last infant dose.
|
13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose)
n=11 Participants
Participants 6 weeks to less than (\<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (\>) 12 months of age (toddler dose), at least 60 days after last infant dose.
|
13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)
n=6 Participants
Participants \<12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at \>12 months of age (toddler dose), at least 60 days after last infant dose.
|
|---|---|---|---|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Infant Series
Common serotypes - serotype 4
|
100.0 Percentage of Participants
Interval 29.2 to 100.0
|
90.9 Percentage of Participants
Interval 58.7 to 99.8
|
100.0 Percentage of Participants
Interval 54.1 to 100.0
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Infant Series
Common serotypes - serotype 6B
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
72.7 Percentage of Participants
Interval 39.0 to 94.0
|
83.3 Percentage of Participants
Interval 35.9 to 99.6
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Infant Series
Common serotypes - serotype 9V
|
66.7 Percentage of Participants
Interval 9.4 to 99.2
|
81.8 Percentage of Participants
Interval 48.2 to 97.7
|
66.7 Percentage of Participants
Interval 22.3 to 95.7
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Infant Series
Common serotypes - serotype 14
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
90.9 Percentage of Participants
Interval 58.7 to 99.8
|
83.3 Percentage of Participants
Interval 35.9 to 99.6
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Infant Series
Common serotype - serotype 18C
|
100.0 Percentage of Participants
Interval 29.2 to 100.0
|
63.6 Percentage of Participants
Interval 30.8 to 89.1
|
83.3 Percentage of Participants
Interval 35.9 to 99.6
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Infant Series
Common serotype - serotype 19F
|
100.0 Percentage of Participants
Interval 29.2 to 100.0
|
100.0 Percentage of Participants
Interval 71.5 to 100.0
|
66.7 Percentage of Participants
Interval 22.3 to 95.7
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Infant Series
Common serotype - serotype 23F
|
100.0 Percentage of Participants
Interval 29.2 to 100.0
|
63.6 Percentage of Participants
Interval 30.8 to 89.1
|
50.0 Percentage of Participants
Interval 11.8 to 88.2
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Infant Series
Additional serotype - serotype 1
|
100.0 Percentage of Participants
Interval 29.2 to 100.0
|
81.8 Percentage of Participants
Interval 48.2 to 97.7
|
83.3 Percentage of Participants
Interval 35.9 to 99.6
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Infant Series
Additional serotype - serotype 3
|
100.0 Percentage of Participants
Interval 29.2 to 100.0
|
54.5 Percentage of Participants
Interval 23.4 to 83.3
|
66.7 Percentage of Participants
Interval 22.3 to 95.7
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Infant Series
Additional serotype - serotype 5
|
66.7 Percentage of Participants
Interval 9.4 to 99.2
|
81.8 Percentage of Participants
Interval 48.2 to 97.7
|
83.3 Percentage of Participants
Interval 35.9 to 99.6
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Infant Series
Additional serotype - serotype 6A
|
66.7 Percentage of Participants
Interval 9.4 to 99.2
|
72.7 Percentage of Participants
Interval 39.0 to 94.0
|
83.3 Percentage of Participants
Interval 35.9 to 99.6
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Infant Series
Additional serotype - serotype 7F
|
100.0 Percentage of Participants
Interval 29.2 to 100.0
|
100.0 Percentage of Participants
Interval 71.5 to 100.0
|
83.3 Percentage of Participants
Interval 35.9 to 99.6
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Infant Series
Additional serotype - serotype 19A
|
33.3 Percentage of Participants
Interval 0.8 to 90.6
|
72.7 Percentage of Participants
Interval 39.0 to 94.0
|
50.0 Percentage of Participants
Interval 11.8 to 88.2
|
SECONDARY outcome
Timeframe: 28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, and after vaccination 2 for Group 3.Population: Evaluable immunogenicity population. N=number of participants with a determinate IgG antibody concentration to the given serotype.
Percentage of participants in 13vPnC Groups 1, 2, and 3 achieving predefined antibody threshold ≥1.0 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) are presented. Exact 2-sided CI based upon the observed proportion of participants.
Outcome measures
| Measure |
13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)
n=2 Participants
Participants \<12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at \>12 months of age (toddler dose), at least 60 days after last infant dose.
|
13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose)
n=2 Participants
Participants 6 weeks to less than (\<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (\>) 12 months of age (toddler dose), at least 60 days after last infant dose.
|
13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)
n=6 Participants
Participants \<12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at \>12 months of age (toddler dose), at least 60 days after last infant dose.
|
|---|---|---|---|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Toddler Dose
Additional serotype - serotype 1
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
83.3 Percentage of Participants
Interval 35.9 to 99.6
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Toddler Dose
Common serotypes - serotype 4
|
50.0 Percentage of Participants
Interval 1.3 to 98.7
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
100.0 Percentage of Participants
Interval 54.1 to 100.0
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Toddler Dose
Common serotypes - serotype 6B
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
100.0 Percentage of Participants
Interval 54.1 to 100.0
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Toddler Dose
Common serotypes - serotype 9V
|
50.0 Percentage of Participants
Interval 1.3 to 98.7
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
100.0 Percentage of Participants
Interval 54.1 to 100.0
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Toddler Dose
Common serotypes - serotype 14
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
100.0 Percentage of Participants
Interval 54.1 to 100.0
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Toddler Dose
Common serotype - serotype 18C
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
83.3 Percentage of Participants
Interval 35.9 to 99.6
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Toddler Dose
Common serotype - serotype 19F
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
83.3 Percentage of Participants
Interval 35.9 to 99.6
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Toddler Dose
Common serotype - serotype 23F
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
83.3 Percentage of Participants
Interval 35.9 to 99.6
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Toddler Dose
Additional serotype - serotype 3
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
50.0 Percentage of Participants
Interval 1.3 to 98.7
|
66.7 Percentage of Participants
Interval 22.3 to 95.7
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Toddler Dose
Additional serotype - serotype 5
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
100.0 Percentage of Participants
Interval 54.1 to 100.0
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Toddler Dose
Additional serotype - serotype 6A
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
100.0 Percentage of Participants
Interval 54.1 to 100.0
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Toddler Dose
Additional serotype - serotype 7F
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
100.0 Percentage of Participants
Interval 54.1 to 100.0
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Toddler Dose
Additional serotype - serotype 19A
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
100.0 Percentage of Participants
Interval 54.1 to 100.0
|
SECONDARY outcome
Timeframe: 28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5.Population: Evaluable immunogenicity population. N=number of participants with a determinate IgG antibody concentration to the given serotype.
Percentage of participants in 13vPnC Groups 4 and 5 achieving predefined antibody threshold ≥1.0 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) are presented. Exact 2-sided CI based upon the observed proportion of participants.
Outcome measures
| Measure |
13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)
Participants \<12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at \>12 months of age (toddler dose), at least 60 days after last infant dose.
|
13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose)
n=4 Participants
Participants 6 weeks to less than (\<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (\>) 12 months of age (toddler dose), at least 60 days after last infant dose.
|
13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)
n=9 Participants
Participants \<12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at \>12 months of age (toddler dose), at least 60 days after last infant dose.
|
|---|---|---|---|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Relevant Catch-up Dose
Common serotypes - serotype 4
|
—
|
100.0 Percentage of Participants
Interval 39.8 to 100.0
|
100.0 Percentage of Participants
Interval 66.4 to 100.0
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Relevant Catch-up Dose
Common serotypes - serotype 6B
|
—
|
100.0 Percentage of Participants
Interval 39.8 to 100.0
|
100.0 Percentage of Participants
Interval 66.4 to 100.0
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Relevant Catch-up Dose
Common serotypes - serotype 9V
|
—
|
100.0 Percentage of Participants
Interval 39.8 to 100.0
|
100.0 Percentage of Participants
Interval 66.4 to 100.0
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Relevant Catch-up Dose
Common serotypes - serotype 14
|
—
|
100.0 Percentage of Participants
Interval 39.8 to 100.0
|
100.0 Percentage of Participants
Interval 66.4 to 100.0
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Relevant Catch-up Dose
Common serotype - serotype 18C
|
—
|
100.0 Percentage of Participants
Interval 39.8 to 100.0
|
100.0 Percentage of Participants
Interval 66.4 to 100.0
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Relevant Catch-up Dose
Common serotype - serotype 19F
|
—
|
100.0 Percentage of Participants
Interval 39.8 to 100.0
|
100.0 Percentage of Participants
Interval 66.4 to 100.0
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Relevant Catch-up Dose
Common serotype - serotype 23F
|
—
|
100.0 Percentage of Participants
Interval 39.8 to 100.0
|
100.0 Percentage of Participants
Interval 66.4 to 100.0
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Relevant Catch-up Dose
Additional serotype - serotype 1
|
—
|
100.0 Percentage of Participants
Interval 39.8 to 100.0
|
66.7 Percentage of Participants
Interval 29.9 to 92.5
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Relevant Catch-up Dose
Additional serotype - serotype 3
|
—
|
100.0 Percentage of Participants
Interval 39.8 to 100.0
|
77.8 Percentage of Participants
Interval 40.0 to 97.2
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Relevant Catch-up Dose
Additional serotype - serotype 5
|
—
|
100.0 Percentage of Participants
Interval 39.8 to 100.0
|
88.9 Percentage of Participants
Interval 51.8 to 99.7
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Relevant Catch-up Dose
Additional serotype - serotype 6A
|
—
|
100.0 Percentage of Participants
Interval 39.8 to 100.0
|
88.9 Percentage of Participants
Interval 51.8 to 99.7
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Relevant Catch-up Dose
Additional serotype - serotype 7F
|
—
|
100.0 Percentage of Participants
Interval 39.8 to 100.0
|
100.0 Percentage of Participants
Interval 66.4 to 100.0
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Relevant Catch-up Dose
Additional serotype - serotype 19A
|
—
|
100.0 Percentage of Participants
Interval 39.8 to 100.0
|
100.0 Percentage of Participants
Interval 66.4 to 100.0
|
SECONDARY outcome
Timeframe: Day 1 through Day 7 after vaccination 1 for Group 4 and after the single vaccination in Group 5.Population: Safety Population: all participants who received at least 1 dose of 13vPnC; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants with specific characteristic
Local reactions were reported by the parent/legal guardian using a diary card. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with 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 have been represented in more than 1 category.
Outcome measures
| Measure |
13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)
Participants \<12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at \>12 months of age (toddler dose), at least 60 days after last infant dose.
|
13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose)
n=65 Participants
Participants 6 weeks to less than (\<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (\>) 12 months of age (toddler dose), at least 60 days after last infant dose.
|
13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)
n=77 Participants
Participants \<12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at \>12 months of age (toddler dose), at least 60 days after last infant dose.
|
|---|---|---|---|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Catch-up Dose 1
Tenderness: Any (n=65,77)
|
—
|
32.3 Percentage of Participants
|
48.1 Percentage of Participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Catch-up Dose 1
Tenderness: Significant (n=63,77)
|
—
|
3.2 Percentage of Participants
|
9.1 Percentage of Participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Catch-up Dose 1
Swelling: Any (n=64,77)
|
—
|
7.8 Percentage of Participants
|
7.8 Percentage of Participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Catch-up Dose 1
Swelling: Mild (n=62,76)
|
—
|
3.2 Percentage of Participants
|
2.6 Percentage of Participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Catch-up Dose 1
Swelling: Moderate (n=63,77)
|
—
|
3.2 Percentage of Participants
|
6.5 Percentage of Participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Catch-up Dose 1
Swelling: Severe (n=63,77)
|
—
|
1.6 Percentage of Participants
|
2.6 Percentage of Participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Catch-up Dose 1
Redness: Any (n=65,77)
|
—
|
15.4 Percentage of Participants
|
13.0 Percentage of Participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Catch-up Dose 1
Redness: Mild (n=63,77)
|
—
|
11.1 Percentage of Participants
|
11.7 Percentage of Participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Catch-up Dose 1
Redness: Moderate (n=64,77)
|
—
|
4.7 Percentage of Participants
|
5.2 Percentage of Participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Catch-up Dose 1
Redness: Severe (n=63,77)
|
—
|
1.6 Percentage of Participants
|
2.6 Percentage of Participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 7 after vaccination 2 for Group 4Population: Safety Population; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants with specific characteristic
Local reactions were reported by the parent/legal guardian using a diary card. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with 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 have been represented in more than 1 category.
Outcome measures
| Measure |
13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)
Participants \<12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at \>12 months of age (toddler dose), at least 60 days after last infant dose.
|
13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose)
n=49 Participants
Participants 6 weeks to less than (\<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (\>) 12 months of age (toddler dose), at least 60 days after last infant dose.
|
13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)
Participants \<12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at \>12 months of age (toddler dose), at least 60 days after last infant dose.
|
|---|---|---|---|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Catch-up Dose 2
Tenderness: Any (n=49)
|
—
|
36.7 Percentage of Participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Catch-up Dose 2
Tenderness: Significant (n=49)
|
—
|
10.2 Percentage of Participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Catch-up Dose 2
Swelling: Any (n=48)
|
—
|
10.4 Percentage of Participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Catch-up Dose 2
Swelling: Mild (n=47)
|
—
|
8.5 Percentage of Participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Catch-up Dose 2
Swelling: Moderate (n=47)
|
—
|
0.0 Percentage of Participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Catch-up Dose 2
Swelling: Severe (n=47)
|
—
|
0.0 Percentage of Participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Catch-up Dose 2
Redness: Any (n=49)
|
—
|
6.1 Percentage of Participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Catch-up Dose 2
Redness: Mild (n=48)
|
—
|
4.2 Percentage of Participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Catch-up Dose 2
Redness: Moderate (n=48)
|
—
|
0.0 Percentage of Participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Catch-up Dose 2
Redness: Severe (n=48)
|
—
|
0.0 Percentage of Participants
|
—
|
SECONDARY outcome
Timeframe: Day 1 through Day 7 after vaccination 1 for Group 4 and after the single vaccination in Group 5.Population: Safety Population; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants with specific characteristic
Systemic events (any fever 38 degrees Celsius \[C\] or higher, decreased appetite, irritability, increased sleep, decreased sleep, hives \[urticaria\], and use of antipyretic medication) were reported using a diary card. Participants may have been represented in more than 1 category.
Outcome measures
| Measure |
13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)
Participants \<12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at \>12 months of age (toddler dose), at least 60 days after last infant dose.
|
13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose)
n=66 Participants
Participants 6 weeks to less than (\<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (\>) 12 months of age (toddler dose), at least 60 days after last infant dose.
|
13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)
n=77 Participants
Participants \<12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at \>12 months of age (toddler dose), at least 60 days after last infant dose.
|
|---|---|---|---|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: Catch-up Dose 1
Fever ≥38 degrees C but ≤39 degrees C (n=35,47)
|
—
|
42.9 Percentage of Participants
|
27.7 Percentage of Participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: Catch-up Dose 1
Fever >39 degrees C but ≤40 degrees C (n=29,43)
|
—
|
20.7 Percentage of Participants
|
11.6 Percentage of Participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: Catch-up Dose 1
Fever >40 degrees C (n=28,40)
|
—
|
7.1 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: Catch-up Dose 1
Decreased appetite (n=66,77)
|
—
|
31.8 Percentage of Participants
|
24.7 Percentage of Participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: Catch-up Dose 1
Irritability (n=66,77)
|
—
|
53.0 Percentage of Participants
|
41.6 Percentage of Participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: Catch-up Dose 1
Increased sleep (n=66,77)
|
—
|
33.3 Percentage of Participants
|
22.1 Percentage of Participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: Catch-up Dose 1
Decreased sleep (n=66,77)
|
—
|
24.2 Percentage of Participants
|
11.7 Percentage of Participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: Catch-up Dose 1
Hives (urticaria) (n=66,77)
|
—
|
3.0 Percentage of Participants
|
2.6 Percentage of Participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: Catch-up Dose 1
Use of medication to treat symptoms (n=65,77)
|
—
|
50.8 Percentage of Participants
|
33.8 Percentage of Participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 7 after vaccination 2 for Group 4Population: Safety Population; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants with specific characteristic
Systemic events (any fever 38 degrees C or higher, decreased appetite, irritability, increased sleep, decreased sleep, hives \[urticaria\], and use of antipyretic medication) were reported using a diary card. Participants may have been represented in more than 1 category.
Outcome measures
| Measure |
13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)
Participants \<12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at \>12 months of age (toddler dose), at least 60 days after last infant dose.
|
13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose)
n=49 Participants
Participants 6 weeks to less than (\<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (\>) 12 months of age (toddler dose), at least 60 days after last infant dose.
|
13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)
Participants \<12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at \>12 months of age (toddler dose), at least 60 days after last infant dose.
|
|---|---|---|---|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: Catch-up Dose 2
Fever ≥38 degrees C but ≤39 degrees C (n=26)
|
—
|
23.1 Percentage of Participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: Catch-up Dose 2
Fever >39 degrees C but ≤40 degrees C (n=22)
|
—
|
9.1 Percentage of Participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: Catch-up Dose 2
Fever >40 degrees C (n=21)
|
—
|
0.0 Percentage of Participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: Catch-up Dose 2
Decreased appetite (n=49)
|
—
|
22.4 Percentage of Participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: Catch-up Dose 2
Irritability (n=49)
|
—
|
57.1 Percentage of Participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: Catch-up Dose 2
Increased sleep (n=49)
|
—
|
26.5 Percentage of Participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: Catch-up Dose 2
Decreased sleep (n=49)
|
—
|
4.1 Percentage of Participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: Catch-up Dose 2
Hives (urticaria) (n=49)
|
—
|
2.0 Percentage of Participants
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: Catch-up Dose 2
Use of medication to treat symptoms (n=49)
|
—
|
42.9 Percentage of Participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to 6 months after last vaccinationPopulation: Safety Population
In order to assess the impact of 13vPnC on the incidence of IPD in the Yukon Kuskokwim (YK) Delta region, the Centers for Disease Control and Prevention (CDC) Arctic Investigation Program (AIP) accessed IPD data through evaluation of ongoing statewide IPD surveillance in Alaska. The CDC's AIP followed IPD (including serotype and vaccination history) to show whether identified cases of IPD received Prevnar, 13vPnC, or both. These data were combined with statewide data and used to identify the overall trend in IPD in the YK Delta region after introduction of 13vPnC.
Outcome measures
| Measure |
13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)
Participants \<12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at \>12 months of age (toddler dose), at least 60 days after last infant dose.
|
13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose)
n=373 Participants
Participants 6 weeks to less than (\<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (\>) 12 months of age (toddler dose), at least 60 days after last infant dose.
|
13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)
Participants \<12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at \>12 months of age (toddler dose), at least 60 days after last infant dose.
|
|---|---|---|---|
|
Number of Cases of Invasive Pneumococcal Disease (IPD) in Participants Less Than 5 Years of Age Due to Any Serotype Contained in 13vPnC
|
—
|
0 Participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3.Population: Evaluable immunogenicity population. N=number of participants with a determinate IgG antibody concentration to the given serotype.
Percentage of participants in 13vPnC Groups 1, 2, and 3 achieving predefined antibody threshold ≥0.15 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) are presented. Exact 2-sided CI based upon the observed proportion of participants.
Outcome measures
| Measure |
13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)
n=3 Participants
Participants \<12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at \>12 months of age (toddler dose), at least 60 days after last infant dose.
|
13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose)
n=11 Participants
Participants 6 weeks to less than (\<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (\>) 12 months of age (toddler dose), at least 60 days after last infant dose.
|
13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)
n=6 Participants
Participants \<12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at \>12 months of age (toddler dose), at least 60 days after last infant dose.
|
|---|---|---|---|
|
Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Infant Series
Additional serotype - serotype 19A
|
100.0 Percentage of Participants
Interval 29.2 to 100.0
|
100.0 Percentage of Participants
Interval 71.5 to 100.0
|
100.0 Percentage of Participants
Interval 54.1 to 100.0
|
|
Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Infant Series
Common serotypes - serotype 4
|
100.0 Percentage of Participants
Interval 29.2 to 100.0
|
100.0 Percentage of Participants
Interval 71.5 to 100.0
|
100.0 Percentage of Participants
Interval 54.1 to 100.0
|
|
Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Infant Series
Common serotypes - serotype 6B
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
100.0 Percentage of Participants
Interval 71.5 to 100.0
|
100.0 Percentage of Participants
Interval 54.1 to 100.0
|
|
Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Infant Series
Common serotypes - serotype 9V
|
100.0 Percentage of Participants
Interval 29.2 to 100.0
|
100.0 Percentage of Participants
Interval 71.5 to 100.0
|
100.0 Percentage of Participants
Interval 54.1 to 100.0
|
|
Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Infant Series
Common serotypes - serotype 14
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
90.9 Percentage of Participants
Interval 58.7 to 99.8
|
100.0 Percentage of Participants
Interval 54.1 to 100.0
|
|
Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Infant Series
Common serotype - serotype 18C
|
100.0 Percentage of Participants
Interval 29.2 to 100.0
|
100.0 Percentage of Participants
Interval 71.5 to 100.0
|
100.0 Percentage of Participants
Interval 54.1 to 100.0
|
|
Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Infant Series
Common serotype - serotype 19F
|
100.0 Percentage of Participants
Interval 29.2 to 100.0
|
100.0 Percentage of Participants
Interval 71.5 to 100.0
|
100.0 Percentage of Participants
Interval 54.1 to 100.0
|
|
Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Infant Series
Common serotype - serotype 23F
|
100.0 Percentage of Participants
Interval 29.2 to 100.0
|
100.0 Percentage of Participants
Interval 71.5 to 100.0
|
100.0 Percentage of Participants
Interval 54.1 to 100.0
|
|
Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Infant Series
Additional serotype - serotype 1
|
100.0 Percentage of Participants
Interval 29.2 to 100.0
|
100.0 Percentage of Participants
Interval 71.5 to 100.0
|
100.0 Percentage of Participants
Interval 54.1 to 100.0
|
|
Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Infant Series
Additional serotype - serotype 3
|
100.0 Percentage of Participants
Interval 29.2 to 100.0
|
100.0 Percentage of Participants
Interval 71.5 to 100.0
|
100.0 Percentage of Participants
Interval 54.1 to 100.0
|
|
Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Infant Series
Additional serotype - serotype 5
|
100.0 Percentage of Participants
Interval 29.2 to 100.0
|
100.0 Percentage of Participants
Interval 71.5 to 100.0
|
100.0 Percentage of Participants
Interval 54.1 to 100.0
|
|
Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Infant Series
Additional serotype - serotype 6A
|
100.0 Percentage of Participants
Interval 29.2 to 100.0
|
100.0 Percentage of Participants
Interval 71.5 to 100.0
|
100.0 Percentage of Participants
Interval 54.1 to 100.0
|
|
Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Infant Series
Additional serotype - serotype 7F
|
100.0 Percentage of Participants
Interval 29.2 to 100.0
|
100.0 Percentage of Participants
Interval 71.5 to 100.0
|
100.0 Percentage of Participants
Interval 54.1 to 100.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, and after vaccination 2 for Group 3.Population: Evaluable immunogenicity population. N=number of participants with a determinate IgG antibody concentration to the given serotype.
Percentage of participants in 13vPnC Groups 1, 2, and 3 achieving predefined antibody threshold ≥0.15 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) are presented. Exact 2-sided CI based upon the observed proportion of participants.
Outcome measures
| Measure |
13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)
n=2 Participants
Participants \<12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at \>12 months of age (toddler dose), at least 60 days after last infant dose.
|
13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose)
n=2 Participants
Participants 6 weeks to less than (\<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (\>) 12 months of age (toddler dose), at least 60 days after last infant dose.
|
13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)
n=6 Participants
Participants \<12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at \>12 months of age (toddler dose), at least 60 days after last infant dose.
|
|---|---|---|---|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Toddler Dose
Common serotypes - serotype 4
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
100.0 Percentage of Participants
Interval 54.1 to 100.0
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Toddler Dose
Common serotypes - serotype 6B
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
100.0 Percentage of Participants
Interval 54.1 to 100.0
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Toddler Dose
Common serotypes - serotype 9V
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
100.0 Percentage of Participants
Interval 54.1 to 100.0
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Toddler Dose
Common serotypes - serotype 14
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
100.0 Percentage of Participants
Interval 54.1 to 100.0
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Toddler Dose
Common serotype - serotype 18C
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
100.0 Percentage of Participants
Interval 54.1 to 100.0
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Toddler Dose
Common serotype - serotype 19F
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
100.0 Percentage of Participants
Interval 54.1 to 100.0
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Toddler Dose
Common serotype - serotype 23F
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
100.0 Percentage of Participants
Interval 54.1 to 100.0
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Toddler Dose
Additional serotype - serotype 1
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
100.0 Percentage of Participants
Interval 54.1 to 100.0
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Toddler Dose
Additional serotype - serotype 3
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
100.0 Percentage of Participants
Interval 54.1 to 100.0
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Toddler Dose
Additional serotype - serotype 5
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
100.0 Percentage of Participants
Interval 54.1 to 100.0
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Toddler Dose
Additional serotype - serotype 6A
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
100.0 Percentage of Participants
Interval 54.1 to 100.0
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Toddler Dose
Additional serotype - serotype 7F
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
100.0 Percentage of Participants
Interval 54.1 to 100.0
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Toddler Dose
Additional serotype - serotype 19A
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
100.0 Percentage of Participants
Interval 54.1 to 100.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5.Population: Evaluable immunogenicity population. N=number of participants with a determinate IgG antibody concentration to the given serotype.
Percentage of participants in 13vPnC Groups 4 and 5 achieving predefined antibody threshold ≥0.15 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) are presented. Exact 2-sided CI based upon the observed proportion of participants.
Outcome measures
| Measure |
13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)
Participants \<12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at \>12 months of age (toddler dose), at least 60 days after last infant dose.
|
13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose)
n=4 Participants
Participants 6 weeks to less than (\<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (\>) 12 months of age (toddler dose), at least 60 days after last infant dose.
|
13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)
n=9 Participants
Participants \<12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at \>12 months of age (toddler dose), at least 60 days after last infant dose.
|
|---|---|---|---|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Relevant Catch-up Dose
Common serotypes - serotype 4
|
—
|
100.0 Percentage of Participants
Interval 39.8 to 100.0
|
100.0 Percentage of Participants
Interval 66.4 to 100.0
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Relevant Catch-up Dose
Common serotypes - serotype 6B
|
—
|
100.0 Percentage of Participants
Interval 39.8 to 100.0
|
100.0 Percentage of Participants
Interval 66.4 to 100.0
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Relevant Catch-up Dose
Common serotypes - serotype 9V
|
—
|
100.0 Percentage of Participants
Interval 39.8 to 100.0
|
100.0 Percentage of Participants
Interval 66.4 to 100.0
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Relevant Catch-up Dose
Common serotypes - serotype 14
|
—
|
100.0 Percentage of Participants
Interval 39.8 to 100.0
|
100.0 Percentage of Participants
Interval 66.4 to 100.0
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Relevant Catch-up Dose
Common serotype - serotype 18C
|
—
|
100.0 Percentage of Participants
Interval 39.8 to 100.0
|
100.0 Percentage of Participants
Interval 66.4 to 100.0
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Relevant Catch-up Dose
Common serotype - serotype 19F
|
—
|
100.0 Percentage of Participants
Interval 39.8 to 100.0
|
100.0 Percentage of Participants
Interval 66.4 to 100.0
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Relevant Catch-up Dose
Common serotype - serotype 23F
|
—
|
100.0 Percentage of Participants
Interval 39.8 to 100.0
|
100.0 Percentage of Participants
Interval 66.4 to 100.0
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Relevant Catch-up Dose
Additional serotype - serotype 1
|
—
|
100.0 Percentage of Participants
Interval 39.8 to 100.0
|
100.0 Percentage of Participants
Interval 66.4 to 100.0
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Relevant Catch-up Dose
Additional serotype - serotype 3
|
—
|
100.0 Percentage of Participants
Interval 39.8 to 100.0
|
100.0 Percentage of Participants
Interval 66.4 to 100.0
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Relevant Catch-up Dose
Additional serotype - serotype 5
|
—
|
100.0 Percentage of Participants
Interval 39.8 to 100.0
|
100.0 Percentage of Participants
Interval 66.4 to 100.0
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Relevant Catch-up Dose
Additional serotype - serotype 6A
|
—
|
100.0 Percentage of Participants
Interval 39.8 to 100.0
|
100.0 Percentage of Participants
Interval 66.4 to 100.0
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Relevant Catch-up Dose
Additional serotype - serotype 7F
|
—
|
100.0 Percentage of Participants
Interval 39.8 to 100.0
|
100.0 Percentage of Participants
Interval 66.4 to 100.0
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Relevant Catch-up Dose
Additional serotype - serotype 19A
|
—
|
100.0 Percentage of Participants
Interval 39.8 to 100.0
|
100.0 Percentage of Participants
Interval 66.4 to 100.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3.Population: Evaluable immunogenicity population. N=number of participants with a determinate antibody concentration to the specified serotype.
Antibody GMCs (mcg/mL) 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) are presented. GMC (13vPnC) with 2-sided 95% CIs were evaluated. CIs are back transformations of confidence levels based on Student t distribution for mean logarithm of concentrations. GMCs were calculated using all participants with available data for specified blood draw.
Outcome measures
| Measure |
13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)
n=3 Participants
Participants \<12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at \>12 months of age (toddler dose), at least 60 days after last infant dose.
|
13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose)
n=11 Participants
Participants 6 weeks to less than (\<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (\>) 12 months of age (toddler dose), at least 60 days after last infant dose.
|
13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)
n=6 Participants
Participants \<12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at \>12 months of age (toddler dose), at least 60 days after last infant dose.
|
|---|---|---|---|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Infant Series
Common serotypes - serotype 4
|
4.27 mcg/mL
Interval 0.49 to 37.05
|
2.64 mcg/mL
Interval 1.55 to 4.49
|
2.11 mcg/mL
Interval 0.93 to 4.8
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Infant Series
Common serotypes - serotype 6B
|
28.60 mcg/mL
Interval 0.12 to 7043.76
|
2.74 mcg/mL
Interval 1.23 to 6.12
|
2.59 mcg/mL
Interval 0.55 to 12.26
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Infant Series
Common serotypes - serotype 9V
|
1.60 mcg/mL
Interval 0.31 to 8.37
|
1.38 mcg/mL
Interval 0.97 to 1.98
|
1.04 mcg/mL
Interval 0.46 to 2.38
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Infant Series
Common serotypes - serotype 14
|
10.73 mcg/mL
Interval 0.06 to 1894.14
|
4.78 mcg/mL
Interval 1.71 to 13.33
|
4.08 mcg/mL
Interval 1.68 to 9.88
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Infant Series
Common serotype - serotype 18C
|
2.99 mcg/mL
Interval 0.4 to 22.62
|
1.83 mcg/mL
Interval 1.04 to 3.21
|
1.66 mcg/mL
Interval 0.92 to 2.98
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Infant Series
Common serotype - serotype 19F
|
2.37 mcg/mL
Interval 1.43 to 3.93
|
3.55 mcg/mL
Interval 2.1 to 6.01
|
1.61 mcg/mL
Interval 0.65 to 4.01
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Infant Series
Common serotype - serotype 23F
|
3.37 mcg/mL
Interval 1.18 to 9.66
|
1.54 mcg/mL
Interval 0.79 to 3.01
|
1.03 mcg/mL
Interval 0.35 to 3.04
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Infant Series
Additional serotype - serotype 1
|
2.87 mcg/mL
Interval 0.3 to 27.24
|
3.33 mcg/mL
Interval 1.68 to 6.62
|
3.02 mcg/mL
Interval 1.06 to 8.6
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Infant Series
Additional serotype - serotype 3
|
5.07 mcg/mL
Interval 1.53 to 16.79
|
0.79 mcg/mL
Interval 0.51 to 1.22
|
1.61 mcg/mL
Interval 0.62 to 4.16
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Infant Series
Additional serotype - serotype 5
|
1.75 mcg/mL
Interval 0.25 to 12.25
|
2.89 mcg/mL
Interval 1.57 to 5.31
|
1.93 mcg/mL
Interval 1.14 to 3.26
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Infant Series
Additional serotype - serotype 6A
|
5.41 mcg/mL
Interval 0.01 to 2495.5
|
2.19 mcg/mL
Interval 0.93 to 5.16
|
2.48 mcg/mL
Interval 0.91 to 6.78
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Infant Series
Additional serotype - serotype 7F
|
6.21 mcg/mL
Interval 1.84 to 20.92
|
3.34 mcg/mL
Interval 1.99 to 5.61
|
3.18 mcg/mL
Interval 1.24 to 8.12
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Infant Series
Additional serotype - serotype 19A
|
0.97 mcg/mL
Interval 0.37 to 2.53
|
1.87 mcg/mL
Interval 1.11 to 3.17
|
1.35 mcg/mL
Interval 0.56 to 3.25
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, after vaccination 2 for Group 3.Population: Evaluable immunogenicity population. N=number of participants with a determinate antibody concentration to the specified serotype.
Antibody GMCs (mcg/mL) 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) with 2-sided 95% CIs were evaluated. CIs are back transformations of confidence levels based on Student t distribution for mean logarithm of concentrations. GMCs were calculated using all participants with available data for specified blood draw.
Outcome measures
| Measure |
13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)
n=2 Participants
Participants \<12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at \>12 months of age (toddler dose), at least 60 days after last infant dose.
|
13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose)
n=2 Participants
Participants 6 weeks to less than (\<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (\>) 12 months of age (toddler dose), at least 60 days after last infant dose.
|
13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)
n=6 Participants
Participants \<12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at \>12 months of age (toddler dose), at least 60 days after last infant dose.
|
|---|---|---|---|
|
GMC for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Toddler Dose
Common serotypes - serotype 4
|
1.76 mcg/mL
Interval 0.0 to 4004.84
|
7.16 mcg/mL
Interval 0.0 to 199911.7
|
2.55 mcg/mL
Interval 1.44 to 4.53
|
|
GMC for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Toddler Dose
Common serotypes - serotype 6B
|
11.32 mcg/mL
Interval 0.01 to 11544.32
|
13.64 mcg/mL
Interval 0.0 to
value=3.929\*10\^11
|
12.01 mcg/mL
Interval 4.23 to 34.08
|
|
GMC for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Toddler Dose
Common serotypes - serotype 9V
|
1.30 mcg/mL
Interval 0.0 to 2387.89
|
2.17 mcg/mL
Interval 0.01 to 373.79
|
2.20 mcg/mL
Interval 1.3 to 3.73
|
|
GMC for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Toddler Dose
Common serotypes - serotype 14
|
8.54 mcg/mL
Interval 0.19 to 377.53
|
12.18 mcg/mL
Interval 0.06 to 2411.14
|
11.42 mcg/mL
Interval 5.9 to 22.12
|
|
GMC for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Toddler Dose
Common serotype - serotype 18C
|
2.42 mcg/mL
Interval 0.08 to 72.55
|
2.35 mcg/mL
Interval 0.0 to 1681.49
|
2.22 mcg/mL
Interval 1.22 to 4.03
|
|
GMC for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Toddler Dose
Common serotype - serotype 19F
|
3.65 mcg/mL
Interval 0.0 to 130178.5
|
11.00 mcg/mL
Interval 0.0 to 11762036.0
|
2.84 mcg/mL
Interval 1.03 to 7.79
|
|
GMC for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Toddler Dose
Common serotype - serotype 23F
|
3.96 mcg/mL
n=2 for this serotype, and the value for both participants was 3.96, thus there was no variability so 95% CI could not be determined
|
3.79 mcg/mL
Interval 0.0 to 66245120.0
|
2.35 mcg/mL
Interval 0.88 to 6.27
|
|
GMC for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Toddler Dose
Additional serotype - serotype 1
|
16.70 mcg/mL
Interval 0.0 to 5685164.0
|
2.15 mcg/mL
Interval 0.0 to 9338.28
|
4.19 mcg/mL
Interval 1.46 to 12.02
|
|
GMC for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Toddler Dose
Additional serotype - serotype 3
|
1.63 mcg/mL
Interval 1.19 to 2.23
|
0.73 mcg/mL
Interval 0.0 to 276.18
|
1.32 mcg/mL
Interval 0.63 to 2.78
|
|
GMC for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Toddler Dose
Additional serotype - serotype 5
|
5.85 mcg/mL
Interval 0.02 to 1606.11
|
4.69 mcg/mL
Interval 0.0 to 36146.55
|
3.56 mcg/mL
Interval 1.96 to 6.46
|
|
GMC for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Toddler Dose
Additional serotype - serotype 6A
|
3.24 mcg/mL
Interval 0.01 to 1555.15
|
17.14 mcg/mL
Interval 0.0 to
value=6.518\*10\^11
|
7.79 mcg/mL
Interval 3.0 to 20.21
|
|
GMC for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Toddler Dose
Additional serotype - serotype 7F
|
4.50 mcg/mL
Interval 0.05 to 440.58
|
7.45 mcg/mL
Interval 0.47 to 117.4
|
5.55 mcg/mL
Interval 2.59 to 11.87
|
|
GMC for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Toddler Dose
Additional serotype - serotype 19A
|
8.86 mcg/mL
Interval 0.0 to 8014211.0
|
10.53 mcg/mL
Interval 2.63 to 42.07
|
3.21 mcg/mL
Interval 1.23 to 8.39
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5.Population: Evaluable immunogenicity population. N=number of participants with a determinate antibody concentration to the specified serotype.
Antibody GMCs (mcg/mL) 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) are presented. GMC (13vPnC) with 2-sided 95% CIs were evaluated. CIs are back transformations of confidence levels based on Student t distribution for mean logarithm of concentrations. GMCs were calculated using all participants with available data for specified blood draw.
Outcome measures
| Measure |
13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)
Participants \<12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at \>12 months of age (toddler dose), at least 60 days after last infant dose.
|
13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose)
n=4 Participants
Participants 6 weeks to less than (\<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (\>) 12 months of age (toddler dose), at least 60 days after last infant dose.
|
13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)
n=9 Participants
Participants \<12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at \>12 months of age (toddler dose), at least 60 days after last infant dose.
|
|---|---|---|---|
|
GMC for Serotype-specific Pneumococcal IgG Antibodies 1 Month After the Relevant Catch-up Dose
Additional serotype - serotype 6A
|
—
|
7.42 mcg/mL
Interval 1.77 to 31.06
|
4.46 mcg/mL
Interval 2.09 to 9.48
|
|
GMC for Serotype-specific Pneumococcal IgG Antibodies 1 Month After the Relevant Catch-up Dose
Additional serotype - serotype 7F
|
—
|
8.81 mcg/mL
Interval 3.32 to 23.39
|
3.14 mcg/mL
Interval 1.93 to 5.08
|
|
GMC for Serotype-specific Pneumococcal IgG Antibodies 1 Month After the Relevant Catch-up Dose
Additional serotype - serotype 19A
|
—
|
4.40 mcg/mL
Interval 2.96 to 6.54
|
5.61 mcg/mL
Interval 2.69 to 11.7
|
|
GMC for Serotype-specific Pneumococcal IgG Antibodies 1 Month After the Relevant Catch-up Dose
Common serotypes - serotype 4
|
—
|
4.16 mcg/mL
Interval 1.16 to 14.91
|
4.92 mcg/mL
Interval 1.94 to 12.5
|
|
GMC for Serotype-specific Pneumococcal IgG Antibodies 1 Month After the Relevant Catch-up Dose
Common serotypes - serotype 6B
|
—
|
16.49 mcg/mL
Interval 4.31 to 63.06
|
22.94 mcg/mL
Interval 10.84 to 48.52
|
|
GMC for Serotype-specific Pneumococcal IgG Antibodies 1 Month After the Relevant Catch-up Dose
Common serotypes - serotype 9V
|
—
|
3.22 mcg/mL
Interval 1.2 to 8.64
|
5.16 mcg/mL
Interval 2.34 to 11.37
|
|
GMC for Serotype-specific Pneumococcal IgG Antibodies 1 Month After the Relevant Catch-up Dose
Common serotypes - serotype 14
|
—
|
9.02 mcg/mL
Interval 2.18 to 37.29
|
16.99 mcg/mL
Interval 6.08 to 47.48
|
|
GMC for Serotype-specific Pneumococcal IgG Antibodies 1 Month After the Relevant Catch-up Dose
Common serotype - serotype 18C
|
—
|
4.22 mcg/mL
Interval 2.22 to 8.05
|
5.08 mcg/mL
Interval 2.43 to 10.63
|
|
GMC for Serotype-specific Pneumococcal IgG Antibodies 1 Month After the Relevant Catch-up Dose
Common serotype - serotype 19F
|
—
|
3.39 mcg/mL
Interval 0.78 to 14.78
|
6.45 mcg/mL
Interval 4.23 to 9.83
|
|
GMC for Serotype-specific Pneumococcal IgG Antibodies 1 Month After the Relevant Catch-up Dose
Common serotype - serotype 23F
|
—
|
4.94 mcg/mL
Interval 1.82 to 13.41
|
5.41 mcg/mL
Interval 2.3 to 12.74
|
|
GMC for Serotype-specific Pneumococcal IgG Antibodies 1 Month After the Relevant Catch-up Dose
Additional serotype - serotype 1
|
—
|
9.37 mcg/mL
Interval 2.89 to 30.34
|
1.25 mcg/mL
Interval 0.64 to 2.46
|
|
GMC for Serotype-specific Pneumococcal IgG Antibodies 1 Month After the Relevant Catch-up Dose
Additional serotype - serotype 3
|
—
|
1.65 mcg/mL
Interval 1.13 to 2.4
|
1.91 mcg/mL
Interval 1.06 to 3.46
|
|
GMC for Serotype-specific Pneumococcal IgG Antibodies 1 Month After the Relevant Catch-up Dose
Additional serotype - serotype 5
|
—
|
4.51 mcg/mL
Interval 2.77 to 7.34
|
2.31 mcg/mL
Interval 1.41 to 3.78
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3.Population: Evaluable immunogenicity population. N=number of participants with a determinate OPA antibody titer to the given serotype.
Percentage of participants in 13vPnC Groups 1, 2, and 3 achieving OPA with 95% CI for serotypes 4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F, and 19A. Exact 2-sided CI based upon the observed proportion of participants. The LLOQ in titers for each serotype was: Pn001, 18; Pn003, 12; Pn004, 21; Pn005, 29; Pn06A, 37; Pn06B, 43, Pn7F, 210; Pn09V, 345; Pn014, 35; Pn18C, 31; Pn19A, 18; Pn19F, 48; and Pn23F, 13. Limit of detection (LOD) established as lowest titer possible in assay, which was 8. OPA titers below LLOQ set to 0.5\*LOD for analysis.
Outcome measures
| Measure |
13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)
n=3 Participants
Participants \<12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at \>12 months of age (toddler dose), at least 60 days after last infant dose.
|
13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose)
n=11 Participants
Participants 6 weeks to less than (\<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (\>) 12 months of age (toddler dose), at least 60 days after last infant dose.
|
13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)
n=5 Participants
Participants \<12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at \>12 months of age (toddler dose), at least 60 days after last infant dose.
|
|---|---|---|---|
|
Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥Lower Limit of Quantitation (LLOQ) Measured 1 Month After the Infant Series
Additional serotype - serotype 6A
|
100.0 Percentage of Participants
Interval 29.2 to 100.0
|
90.0 Percentage of Participants
Interval 55.5 to 99.7
|
100.0 Percentage of Participants
Interval 47.8 to 100.0
|
|
Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥Lower Limit of Quantitation (LLOQ) Measured 1 Month After the Infant Series
Common serotypes - serotype 4
|
66.7 Percentage of Participants
Interval 9.4 to 99.2
|
88.9 Percentage of Participants
Interval 51.8 to 99.7
|
75.0 Percentage of Participants
Interval 19.4 to 99.4
|
|
Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥Lower Limit of Quantitation (LLOQ) Measured 1 Month After the Infant Series
Common serotypes - serotype 6B
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
100.0 Percentage of Participants
Interval 66.4 to 100.0
|
100.0 Percentage of Participants
Interval 39.8 to 100.0
|
|
Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥Lower Limit of Quantitation (LLOQ) Measured 1 Month After the Infant Series
Common serotypes - serotype 9V
|
66.7 Percentage of Participants
Interval 9.4 to 99.2
|
30.0 Percentage of Participants
Interval 6.7 to 65.2
|
0.0 Percentage of Participants
Interval 0.0 to 70.8
|
|
Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥Lower Limit of Quantitation (LLOQ) Measured 1 Month After the Infant Series
Common serotypes - serotype 14
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
100.0 Percentage of Participants
Interval 54.1 to 100.0
|
75.0 Percentage of Participants
Interval 19.4 to 99.4
|
|
Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥Lower Limit of Quantitation (LLOQ) Measured 1 Month After the Infant Series
Common serotype - serotype 18C
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
100.0 Percentage of Participants
Interval 59.0 to 100.0
|
100.0 Percentage of Participants
Interval 39.8 to 100.0
|
|
Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥Lower Limit of Quantitation (LLOQ) Measured 1 Month After the Infant Series
Common serotype - serotype 19F
|
0.0 Percentage of Participants
Interval 0.0 to 97.5
|
88.9 Percentage of Participants
Interval 51.8 to 99.7
|
50.0 Percentage of Participants
Interval 6.8 to 93.2
|
|
Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥Lower Limit of Quantitation (LLOQ) Measured 1 Month After the Infant Series
Common serotype - serotype 23F
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
88.9 Percentage of Participants
Interval 51.8 to 99.7
|
66.7 Percentage of Participants
Interval 9.4 to 99.2
|
|
Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥Lower Limit of Quantitation (LLOQ) Measured 1 Month After the Infant Series
Additional serotype - serotype 1
|
33.3 Percentage of Participants
Interval 0.8 to 90.6
|
60.0 Percentage of Participants
Interval 26.2 to 87.8
|
0.0 Percentage of Participants
Interval 0.0 to 60.2
|
|
Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥Lower Limit of Quantitation (LLOQ) Measured 1 Month After the Infant Series
Additional serotype - serotype 3
|
100.0 Percentage of Participants
Interval 29.2 to 100.0
|
90.9 Percentage of Participants
Interval 58.7 to 99.8
|
100.0 Percentage of Participants
Interval 47.8 to 100.0
|
|
Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥Lower Limit of Quantitation (LLOQ) Measured 1 Month After the Infant Series
Additional serotype - serotype 5
|
33.3 Percentage of Participants
Interval 0.8 to 90.6
|
70.0 Percentage of Participants
Interval 34.8 to 93.3
|
60.0 Percentage of Participants
Interval 14.7 to 94.7
|
|
Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥Lower Limit of Quantitation (LLOQ) Measured 1 Month After the Infant Series
Additional serotype - serotype 7F
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
100.0 Percentage of Participants
Interval 69.2 to 100.0
|
100.0 Percentage of Participants
Interval 47.8 to 100.0
|
|
Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥Lower Limit of Quantitation (LLOQ) Measured 1 Month After the Infant Series
Additional serotype - serotype 19A
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
80.0 Percentage of Participants
Interval 44.4 to 97.5
|
75.0 Percentage of Participants
Interval 19.4 to 99.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, and after vaccination 2 for Group 3.Population: Evaluable immunogenicity population. N=number of participants with a determinate OPA antibody titer to the given serotype.
Percentage of participants in 13vPnC Groups 1, 2 and 3 achieving OPA with 95% CI for serotypes 4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F, and 19A. Exact 2-sided CI based upon the observed proportion of participants. The LLOQ in titers for each serotype was: Pn001, 18; Pn003, 12; Pn004, 21; Pn005, 29; Pn06A, 37; Pn06B, 43, Pn7F, 210; Pn09V, 345; Pn014, 35; Pn18C, 31; Pn19A, 18; Pn19F, 48; and Pn23F, 13. Limit of detection (LOD) established as lowest titer possible in assay, which was 8. OPA titers below LLOQ set to 0.5\*LOD for analysis.
Outcome measures
| Measure |
13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)
n=1 Participants
Participants \<12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at \>12 months of age (toddler dose), at least 60 days after last infant dose.
|
13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose)
n=2 Participants
Participants 6 weeks to less than (\<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (\>) 12 months of age (toddler dose), at least 60 days after last infant dose.
|
13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)
n=6 Participants
Participants \<12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at \>12 months of age (toddler dose), at least 60 days after last infant dose.
|
|---|---|---|---|
|
Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Toddler Dose
Common serotypes - serotype 4
|
100.0 Percentage of Participants
Interval 2.5 to 100.0
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
50.0 Percentage of Participants
Interval 11.8 to 88.2
|
|
Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Toddler Dose
Common serotypes - serotype 6B
|
100.0 Percentage of Participants
Interval 2.5 to 100.0
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
80.0 Percentage of Participants
Interval 28.4 to 99.5
|
|
Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Toddler Dose
Common serotypes - serotype 9V
|
100.0 Percentage of Participants
Interval 2.5 to 100.0
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
83.3 Percentage of Participants
Interval 35.9 to 99.6
|
|
Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Toddler Dose
Common serotypes - serotype 14
|
100.0 Percentage of Participants
Interval 2.5 to 100.0
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
100.0 Percentage of Participants
Interval 29.2 to 100.0
|
|
Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Toddler Dose
Common serotype - serotype 18C
|
100.0 Percentage of Participants
Interval 2.5 to 100.0
|
100.0 Percentage of Participants
Interval 2.5 to 100.0
|
80.0 Percentage of Participants
Interval 28.4 to 99.5
|
|
Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Toddler Dose
Common serotype - serotype 19F
|
100.0 Percentage of Participants
Interval 2.5 to 100.0
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
60.0 Percentage of Participants
Interval 14.7 to 94.7
|
|
Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Toddler Dose
Common serotype - serotype 23F
|
100.0 Percentage of Participants
Interval 2.5 to 100.0
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
100.0 Percentage of Participants
Interval 47.8 to 100.0
|
|
Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Toddler Dose
Additional serotype - serotype 1
|
100.0 Percentage of Participants
Interval 2.5 to 100.0
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
83.3 Percentage of Participants
Interval 35.9 to 99.6
|
|
Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Toddler Dose
Additional serotype - serotype 3
|
100.0 Percentage of Participants
Interval 2.5 to 100.0
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
100.0 Percentage of Participants
Interval 54.1 to 100.0
|
|
Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Toddler Dose
Additional serotype - serotype 5
|
100.0 Percentage of Participants
Interval 2.5 to 100.0
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
66.7 Percentage of Participants
Interval 22.3 to 95.7
|
|
Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Toddler Dose
Additional serotype - serotype 6A
|
100.0 Percentage of Participants
Interval 2.5 to 100.0
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
100.0 Percentage of Participants
Interval 54.1 to 100.0
|
|
Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Toddler Dose
Additional serotype - serotype 7F
|
100.0 Percentage of Participants
Interval 2.5 to 100.0
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
100.0 Percentage of Participants
Interval 54.1 to 100.0
|
|
Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Toddler Dose
Additional serotype - serotype 19A
|
100.0 Percentage of Participants
Interval 2.5 to 100.0
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
100.0 Percentage of Participants
Interval 47.8 to 100.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5.Population: Evaluable immunogenicity population. N=number of participants with a determinate OPA antibody titer to the given serotype.
Percentage of participants in 13vPnC Groups 4 and 5 achieving OPA with 95% CI for serotypes 4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F, and 19A. Exact 2-sided CI based upon the observed proportion of participants. The LLOQ in titers for each serotype was: Pn001, 18; Pn003, 12; Pn004, 21; Pn005, 29; Pn06A, 37; Pn06B, 43, Pn7F, 210; Pn09V, 345; Pn014, 35; Pn18C, 31; Pn19A, 18; Pn19F, 48; and Pn23F, 13. Limit of detection (LOD) established as lowest titer possible in assay, which was 8. OPA titers below LLOQ set to 0.5\*LOD for analysis.
Outcome measures
| Measure |
13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)
Participants \<12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at \>12 months of age (toddler dose), at least 60 days after last infant dose.
|
13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose)
n=4 Participants
Participants 6 weeks to less than (\<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (\>) 12 months of age (toddler dose), at least 60 days after last infant dose.
|
13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)
n=8 Participants
Participants \<12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at \>12 months of age (toddler dose), at least 60 days after last infant dose.
|
|---|---|---|---|
|
Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Relevant Catch-up Dose
Common serotypes - serotype 4
|
—
|
100.0 Percentage of Participants
Interval 29.2 to 100.0
|
100.0 Percentage of Participants
Interval 63.1 to 100.0
|
|
Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Relevant Catch-up Dose
Common serotypes - serotype 6B
|
—
|
100.0 Percentage of Participants
Interval 29.2 to 100.0
|
100.0 Percentage of Participants
Interval 54.1 to 100.0
|
|
Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Relevant Catch-up Dose
Common serotypes - serotype 9V
|
—
|
100.0 Percentage of Participants
Interval 39.8 to 100.0
|
100.0 Percentage of Participants
Interval 54.1 to 100.0
|
|
Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Relevant Catch-up Dose
Common serotypes - serotype 14
|
—
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
100.0 Percentage of Participants
Interval 54.1 to 100.0
|
|
Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Relevant Catch-up Dose
Common serotype - serotype 18C
|
—
|
100.0 Percentage of Participants
Interval 29.2 to 100.0
|
100.0 Percentage of Participants
Interval 54.1 to 100.0
|
|
Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Relevant Catch-up Dose
Common serotype - serotype 19F
|
—
|
100.0 Percentage of Participants
Interval 29.2 to 100.0
|
100.0 Percentage of Participants
Interval 54.1 to 100.0
|
|
Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Relevant Catch-up Dose
Common serotype - serotype 23F
|
—
|
100.0 Percentage of Participants
Interval 29.2 to 100.0
|
100.0 Percentage of Participants
Interval 54.1 to 100.0
|
|
Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Relevant Catch-up Dose
Additional serotype - serotype 1
|
—
|
100.0 Percentage of Participants
Interval 39.8 to 100.0
|
87.5 Percentage of Participants
Interval 47.3 to 99.7
|
|
Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Relevant Catch-up Dose
Additional serotype - serotype 3
|
—
|
100.0 Percentage of Participants
Interval 39.8 to 100.0
|
100.0 Percentage of Participants
Interval 63.1 to 100.0
|
|
Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Relevant Catch-up Dose
Additional serotype - serotype 5
|
—
|
100.0 Percentage of Participants
Interval 39.8 to 100.0
|
75.0 Percentage of Participants
Interval 34.9 to 96.8
|
|
Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Relevant Catch-up Dose
Additional serotype - serotype 6A
|
—
|
100.0 Percentage of Participants
Interval 39.8 to 100.0
|
87.5 Percentage of Participants
Interval 47.3 to 99.7
|
|
Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Relevant Catch-up Dose
Additional serotype - serotype 7F
|
—
|
100.0 Percentage of Participants
Interval 39.8 to 100.0
|
100.0 Percentage of Participants
Interval 63.1 to 100.0
|
|
Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Relevant Catch-up Dose
Additional serotype - serotype 19A
|
—
|
100.0 Percentage of Participants
Interval 39.8 to 100.0
|
100.0 Percentage of Participants
Interval 47.8 to 100.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3.Population: Evaluable immunogenicity population. N=number of participants with a determinate OPA antibody titer to the given serotype.
Antibody geometric mean titers as measured by OPA assay 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). GMTs were calculated using all participants with available data for the specified blood draw. CIs for the GMTs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the titers.
Outcome measures
| Measure |
13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)
n=3 Participants
Participants \<12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at \>12 months of age (toddler dose), at least 60 days after last infant dose.
|
13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose)
n=11 Participants
Participants 6 weeks to less than (\<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (\>) 12 months of age (toddler dose), at least 60 days after last infant dose.
|
13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)
n=5 Participants
Participants \<12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at \>12 months of age (toddler dose), at least 60 days after last infant dose.
|
|---|---|---|---|
|
Pneumococcal OPA Geometric Mean Titers (GMTs) 1 Month After the Infant Series
Common serotypes - serotype 4
|
36 Titers
Interval 0.3 to 4185.7
|
123 Titers
Interval 38.4 to 390.6
|
116 Titers
Interval 3.1 to 4294.7
|
|
Pneumococcal OPA Geometric Mean Titers (GMTs) 1 Month After the Infant Series
Common serotypes - serotype 9V
|
120 Titers
Interval 0.1 to 199619.2
|
20 Titers
Interval 3.1 to 123.1
|
4 Titers
Within group, confidence intervals for serotypes for which participants all have the same titer value were not computed since variability cannot be estimated.
|
|
Pneumococcal OPA Geometric Mean Titers (GMTs) 1 Month After the Infant Series
Common serotype - serotype 19F
|
4 Titers
Within group, confidence intervals for serotypes for which participants all have the same titer value were not computed since variability cannot be estimated.
|
151 Titers
Interval 49.6 to 457.7
|
31 Titers
Interval 0.7 to 1348.9
|
|
Pneumococcal OPA Geometric Mean Titers (GMTs) 1 Month After the Infant Series
Common serotype - serotype 23F
|
566 Titers
Interval 182.6 to 1755.9
|
299 Titers
Interval 79.5 to 1124.8
|
81 Titers
Interval 0.1 to 52488.1
|
|
Pneumococcal OPA Geometric Mean Titers (GMTs) 1 Month After the Infant Series
Additional serotype - serotype 1
|
7 Titers
Interval 0.5 to 109.4
|
41 Titers
Interval 9.2 to 183.5
|
4 Titers
Within group, confidence intervals for serotypes for which participants all have the same titer value were not computed since variability cannot be estimated.
|
|
Pneumococcal OPA Geometric Mean Titers (GMTs) 1 Month After the Infant Series
Additional serotype - serotype 3
|
206 Titers
Interval 66.1 to 639.0
|
58 Titers
Interval 28.9 to 117.7
|
82 Titers
Interval 21.7 to 311.6
|
|
Pneumococcal OPA Geometric Mean Titers (GMTs) 1 Month After the Infant Series
Additional serotype - serotype 5
|
9 Titers
Interval 0.3 to 234.2
|
26 Titers
Interval 9.6 to 72.3
|
18 Titers
Interval 2.9 to 110.8
|
|
Pneumococcal OPA Geometric Mean Titers (GMTs) 1 Month After the Infant Series
Additional serotype - serotype 6A
|
984 Titers
Interval 179.7 to 5383.5
|
731 Titers
Interval 182.2 to 2933.6
|
1069 Titers
Interval 337.1 to 3390.4
|
|
Pneumococcal OPA Geometric Mean Titers (GMTs) 1 Month After the Infant Series
Additional serotype - serotype 7F
|
3485 Titers
Interval 2308.5 to 5261.5
|
1396 Titers
Interval 790.5 to 2467.0
|
1177 Titers
Interval 692.5 to 2001.6
|
|
Pneumococcal OPA Geometric Mean Titers (GMTs) 1 Month After the Infant Series
Common serotype - serotype 6B
|
1790 Titers
Interval 0.0 to 72147076.0
|
1280 Titers
Interval 610.3 to 2683.5
|
1450 Titers
Interval 370.4 to 5675.6
|
|
Pneumococcal OPA Geometric Mean Titers (GMTs) 1 Month After the Infant Series
Common serotype - serotype 14
|
449 Titers
Interval 0.1 to 2059598.0
|
332 Titers
Interval 98.0 to 1124.2
|
71 Titers
Interval 3.3 to 1516.0
|
|
Pneumococcal OPA Geometric Mean Titers (GMTs) 1 Month After the Infant Series
Common serotype - serotype 18C
|
906 Titers
Interval 0.6 to 1340206.0
|
868 Titers
Interval 304.4 to 2475.0
|
452 Titers
Interval 67.7 to 3023.6
|
|
Pneumococcal OPA Geometric Mean Titers (GMTs) 1 Month After the Infant Series
Additional serotype - serotype 19A
|
380 Titers
Interval 0.0 to
value=1.3309\*10\^8
|
58 Titers
Interval 17.7 to 191.3
|
158 Titers
Interval 2.5 to 9872.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, after vaccination 2 for Group 3.Population: Evaluable immunogenicity population. N=number of participants with a determinate OPA antibody titer to the given serotype.
Antibody geometric mean titers as measured by OPA assay 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). GMTs were calculated using all subjects with available data for the specified blood draw. CIs for the GMTs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the titers.
Outcome measures
| Measure |
13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)
n=1 Participants
Participants \<12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at \>12 months of age (toddler dose), at least 60 days after last infant dose.
|
13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose)
n=2 Participants
Participants 6 weeks to less than (\<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (\>) 12 months of age (toddler dose), at least 60 days after last infant dose.
|
13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)
n=6 Participants
Participants \<12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at \>12 months of age (toddler dose), at least 60 days after last infant dose.
|
|---|---|---|---|
|
Pneumococcal OPA GMTs 1 Month After the Toddler Dose
Additional serotype - serotype 3
|
402 Titers
Within group, confidence intervals for serotypes with only 1 participant who had a determinate OPA antibody titer were not computed since variability cannot be estimated.
|
159 Titers
Interval 0.2 to 141793.2
|
138 Titers
Interval 60.9 to 313.7
|
|
Pneumococcal OPA GMTs 1 Month After the Toddler Dose
Additional serotype - serotype 19A
|
427 Titers
Within group, confidence intervals for serotypes with only 1 participant who had a determinate OPA antibody titer were not computed since variability cannot be estimated.
|
1259 Titers
Interval 210.3 to 7542.2
|
140 Titers
Interval 22.7 to 860.3
|
|
Pneumococcal OPA GMTs 1 Month After the Toddler Dose
Common serotype - serotype 6B
|
12470 Titers
Within group, confidence intervals for serotypes with only 1 participant who had a determinate OPA antibody titer were not computed since variability cannot be estimated.
|
1565 Titers
Interval 0.0 to
value=2.4794\*10\^8
|
605 Titers
Interval 17.1 to 21473.7
|
|
Pneumococcal OPA GMTs 1 Month After the Toddler Dose
Common serotypes - serotype 4
|
220 Titers
Within group, confidence intervals for serotypes with only 1 participant who had a determinate OPA antibody titer were not computed since variability cannot be estimated.
|
599 Titers
Interval 422.4 to 850.2
|
58 Titers
Interval 2.6 to 1317.2
|
|
Pneumococcal OPA GMTs 1 Month After the Toddler Dose
Common serotypes - serotype 9V
|
2765 Titers
Within group, confidence intervals for serotypes with only 1 participant who had a determinate OPA antibody titer were not computed since variability cannot be estimated.
|
428 Titers
Interval 68.2 to 2681.9
|
460 Titers
Interval 35.0 to 6035.8
|
|
Pneumococcal OPA GMTs 1 Month After the Toddler Dose
Common serotypes - serotype 14
|
779 Titers
Within group, confidence intervals for serotypes with only 1 participant who had a determinate OPA antibody titer were not computed since variability cannot be estimated.
|
775 Titers
Interval 5.8 to 104290.7
|
551 Titers
Interval 73.6 to 4120.2
|
|
Pneumococcal OPA GMTs 1 Month After the Toddler Dose
Common serotype - serotype 18C
|
4316 Titers
Within group, confidence intervals for serotypes with only 1 participant who had a determinate OPA antibody titer were not computed since variability cannot be estimated.
|
3311 Titers
Within group, confidence intervals for serotypes with only 1 participant who had a determinate OPA antibody titer were not computed since variability cannot be estimated.
|
387 Titers
Interval 14.8 to 10145.6
|
|
Pneumococcal OPA GMTs 1 Month After the Toddler Dose
Additional serotype - serotype 1
|
165 Titers
Within group, confidence intervals for serotypes with only 1 participant who had a determinate OPA antibody titer were not computed since variability cannot be estimated.
|
46 Titers
Interval 0.1 to 14754.5
|
66 Titers
Interval 14.4 to 305.2
|
|
Pneumococcal OPA GMTs 1 Month After the Toddler Dose
Additional serotype - serotype 5
|
88 Titers
Within group, confidence intervals for serotypes with only 1 participant who had a determinate OPA antibody titer were not computed since variability cannot be estimated.
|
87 Titers
Interval 0.8 to 9175.7
|
30 Titers
Interval 5.4 to 164.2
|
|
Pneumococcal OPA GMTs 1 Month After the Toddler Dose
Additional serotype - serotype 7F
|
6105 Titers
Within group, confidence intervals for serotypes with only 1 participant who had a determinate OPA antibody titer were not computed since variability cannot be estimated.
|
4590 Titers
Interval 258.5 to 81484.1
|
1575 Titers
Interval 810.3 to 3061.7
|
|
Pneumococcal OPA GMTs 1 Month After the Toddler Dose
Common serotype - serotype 19F
|
532 Titers
Within group, confidence intervals for serotypes with only 1 participant who had a determinate OPA antibody titer were not computed since variability cannot be estimated.
|
397 Titers
Interval 0.0 to
value=2.4862\*10\^8
|
73 Titers
Interval 2.5 to 2087.3
|
|
Pneumococcal OPA GMTs 1 Month After the Toddler Dose
Common serotype - serotype 23F
|
1660 Titers
Within group, confidence intervals for serotypes with only 1 participant who had a determinate OPA antibody titer were not computed since variability cannot be estimated.
|
227 Titers
Interval 0.0 to
value=1.208\*10\^12
|
313 Titers
Interval 30.6 to 3195.2
|
|
Pneumococcal OPA GMTs 1 Month After the Toddler Dose
Additional serotype - serotype 6A
|
6954 Titers
Within group, confidence intervals for serotypes with only 1 participant who had a determinate OPA antibody titer were not computed since variability cannot be estimated.
|
3207 Titers
Interval 0.0 to
value=1.9613\*10\^9
|
1688 Titers
Interval 480.3 to 5929.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5.Population: Evaluable immunogenicity population. N=number of participants with a determinate OPA antibody titer to the given serotype.
Antibody geometric mean titers as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). GMTs were calculated using all participants with available data for the specified blood draw. CIs for the GMTs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the titers.
Outcome measures
| Measure |
13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)
Participants \<12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at \>12 months of age (toddler dose), at least 60 days after last infant dose.
|
13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose)
n=4 Participants
Participants 6 weeks to less than (\<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (\>) 12 months of age (toddler dose), at least 60 days after last infant dose.
|
13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)
n=8 Participants
Participants \<12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at \>12 months of age (toddler dose), at least 60 days after last infant dose.
|
|---|---|---|---|
|
Pneumococcal OPA GMTs 1 Month After the Relevant Catch-up Dose
Common serotypes - serotype 4
|
—
|
594 Titers
Interval 107.1 to 3295.5
|
1165 Titers
Interval 261.1 to 5197.9
|
|
Pneumococcal OPA GMTs 1 Month After the Relevant Catch-up Dose
Common serotypes - serotype 6B
|
—
|
7236 Titers
Interval 3423.7 to 15294.0
|
6795 Titers
Interval 795.9 to 58012.5
|
|
Pneumococcal OPA GMTs 1 Month After the Relevant Catch-up Dose
Common serotypes - serotype 9V
|
—
|
2748 Titers
Interval 457.9 to 16485.4
|
2979 Titers
Interval 883.6 to 10040.5
|
|
Pneumococcal OPA GMTs 1 Month After the Relevant Catch-up Dose
Common serotypes - serotype 14
|
—
|
1159 Titers
Interval 31.2 to 42979.5
|
1547 Titers
Interval 347.4 to 6892.2
|
|
Pneumococcal OPA GMTs 1 Month After the Relevant Catch-up Dose
Common serotype - serotype 18C
|
—
|
5910 Titers
Interval 1824.6 to 19141.1
|
1871 Titers
Interval 915.7 to 3824.2
|
|
Pneumococcal OPA GMTs 1 Month After the Relevant Catch-up Dose
Common serotype - serotype 19F
|
—
|
1584 Titers
Interval 463.4 to 5417.3
|
594 Titers
Interval 84.8 to 4164.9
|
|
Pneumococcal OPA GMTs 1 Month After the Relevant Catch-up Dose
Common serotype - serotype 23F
|
—
|
2870 Titers
Interval 2572.2 to 3203.4
|
1240 Titers
Interval 423.0 to 3632.5
|
|
Pneumococcal OPA GMTs 1 Month After the Relevant Catch-up Dose
Additional serotype - serotype 1
|
—
|
402 Titers
Interval 285.8 to 564.7
|
62 Titers
Interval 18.0 to 211.6
|
|
Pneumococcal OPA GMTs 1 Month After the Relevant Catch-up Dose
Additional serotype - serotype 3
|
—
|
218 Titers
Interval 102.0 to 466.8
|
202 Titers
Interval 136.0 to 299.3
|
|
Pneumococcal OPA GMTs 1 Month After the Relevant Catch-up Dose
Additional serotype - serotype 5
|
—
|
128 Titers
Interval 15.9 to 1032.0
|
63 Titers
Interval 13.3 to 302.2
|
|
Pneumococcal OPA GMTs 1 Month After the Relevant Catch-up Dose
Additional serotype - serotype 6A
|
—
|
9067 Titers
Interval 5187.0 to 15848.5
|
2292 Titers
Interval 231.2 to 22724.0
|
|
Pneumococcal OPA GMTs 1 Month After the Relevant Catch-up Dose
Additional serotype - serotype 7F
|
—
|
7776 Titers
Interval 3701.3 to 16335.8
|
6086 Titers
Interval 2680.9 to 13818.2
|
|
Pneumococcal OPA GMTs 1 Month After the Relevant Catch-up Dose
Additional serotype - serotype 19A
|
—
|
815 Titers
Interval 549.9 to 1206.8
|
400 Titers
Interval 68.4 to 2344.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3.Population: Correlative analysis output data are only available as figures and were not analyzed or presented statistically.
Outcome measures
| Measure |
13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)
n=3 Participants
Participants \<12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at \>12 months of age (toddler dose), at least 60 days after last infant dose.
|
13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose)
n=11 Participants
Participants 6 weeks to less than (\<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (\>) 12 months of age (toddler dose), at least 60 days after last infant dose.
|
13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)
n=5 Participants
Participants \<12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at \>12 months of age (toddler dose), at least 60 days after last infant dose.
|
|---|---|---|---|
|
Correlation of OPA and IgG Values for Each 13vPnC Serotype 1 Month After the Infant Series
|
NA Participants
Correlative analysis output data are only available as figures and were not analyzed or presented statistically.
|
NA Participants
Correlative analysis output data are only available as figures and were not analyzed or presented statistically.
|
NA Participants
Correlative analysis output data are only available as figures and were not analyzed or presented statistically.
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, and after vaccination 2 for Group 3.Population: Correlative analysis output data are only available as figures and were not analyzed or presented statistically.
Outcome measures
| Measure |
13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)
n=1 Participants
Participants \<12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at \>12 months of age (toddler dose), at least 60 days after last infant dose.
|
13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose)
n=2 Participants
Participants 6 weeks to less than (\<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (\>) 12 months of age (toddler dose), at least 60 days after last infant dose.
|
13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)
n=6 Participants
Participants \<12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at \>12 months of age (toddler dose), at least 60 days after last infant dose.
|
|---|---|---|---|
|
Correlation of OPA and IgG Values for Each 13vPnC Serotype 1 Month After the Toddler Dose
|
NA Participants
Correlative analysis output data are only available as figures and were not analyzed or presented statistically.
|
NA Participants
Correlative analysis output data are only available as figures and were not analyzed or presented statistically.
|
NA Participants
Correlative analysis output data are only available as figures and were not analyzed or presented statistically.
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5.Population: Correlative analysis output data are only available as figures and were not analyzed or presented statistically.
Outcome measures
| Measure |
13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)
Participants \<12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at \>12 months of age (toddler dose), at least 60 days after last infant dose.
|
13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose)
n=4 Participants
Participants 6 weeks to less than (\<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (\>) 12 months of age (toddler dose), at least 60 days after last infant dose.
|
13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)
n=8 Participants
Participants \<12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at \>12 months of age (toddler dose), at least 60 days after last infant dose.
|
|---|---|---|---|
|
Correlation of OPA and IgG Values for Each 13vPnC Serotype 1 Month After the Relevant Catch-up Dose
|
—
|
NA Participants
Correlative analysis output data are only available as figures and were not analyzed or presented statistically.
|
NA Participants
Correlative analysis output data are only available as figures and were not analyzed or presented statistically.
|
Adverse Events
Group 1 (Infant Series)
Serious events: 21 serious events
Other events: 11 other events
Deaths: 0 deaths
Group 2 (Infant Series)
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Group 3 (Infant Series)
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Group 1 (Toddler Dose)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 2 (Toddler Dose)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 3 (Toddler Dose)
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 4 (2 Catch-Up Doses)
Serious events: 3 serious events
Other events: 1 other events
Deaths: 0 deaths
Group 5 (1 Catch-Up Dose)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1 (Infant Series)
n=151 participants at risk
Participants 6 weeks to \<10 months of age with 0 prior doses of Prevnar received 3 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series).
|
Group 2 (Infant Series)
n=51 participants at risk
Participants \<12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series)
|
Group 3 (Infant Series)
n=25 participants at risk
Participants \<12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series)
|
Group 1 (Toddler Dose)
n=15 participants at risk
Participants \>12 months of age received a single IM 0.5 mL dose of 13vPnC at least 60 days after last infant dose (toddler dose)
|
Group 2 (Toddler Dose)
n=23 participants at risk
Participants \>12 months of age received a single IM 0.5 mL dose of 13vPnC at least 60 days after last infant dose (toddler dose)
|
Group 3 (Toddler Dose)
n=16 participants at risk
Participants \>12 months of age received a single IM 0.5 mL dose of 13vPnC at least 60 days after last infant dose (toddler dose)
|
Group 4 (2 Catch-Up Doses)
n=66 participants at risk
Participants ≥12 months to \<2 years of age received 2 single IM 0.5 mL doses of 13vPnC at least 60 days apart.
|
Group 5 (1 Catch-Up Dose)
n=79 participants at risk
Participants ≥2 years to \<5 years of age received a single IM 0.5 mL dose of 13vPnC.
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.66%
1/151 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/51 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/25 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/16 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/66 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/79 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/151 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/51 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/25 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/16 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.5%
1/66 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/79 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Congenital, familial and genetic disorders
Laryngomalacia
|
0.00%
0/151 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/51 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/25 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.2%
1/16 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/66 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/79 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Pyrexia
|
1.3%
2/151 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/51 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/25 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/16 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/66 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/79 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Pneumonia
|
2.6%
4/151 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/51 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.0%
1/25 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/16 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.5%
1/66 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/79 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Respiratory syncytial virus bronchiolitis
|
3.3%
5/151 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.0%
1/51 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/25 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/16 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/66 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/79 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Influenza
|
2.0%
3/151 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.0%
1/51 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.0%
1/25 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/16 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.5%
1/66 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/79 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Pneumonia respiratory syncytial viral
|
2.0%
3/151 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/51 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/25 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/16 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/66 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/79 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Bronchiolitis
|
1.3%
2/151 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/51 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/25 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/16 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/66 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/79 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Urinary tract infection
|
1.3%
2/151 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/51 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/25 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/16 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/66 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/79 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Cellulitis staphylococcal
|
0.66%
1/151 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/51 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/25 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/16 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/66 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/79 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Meningitis haemophilus
|
0.66%
1/151 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/51 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/25 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/16 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/66 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/79 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Septic arthritis haemophilus
|
0.66%
1/151 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/51 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/25 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/16 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/66 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/79 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.66%
1/151 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/51 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/25 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/16 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/66 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/79 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Meningitis viral
|
0.00%
0/151 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/51 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.0%
1/25 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/16 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/66 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/79 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Abscess
|
0.00%
0/151 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/51 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/25 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/16 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.5%
1/66 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/79 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.66%
1/151 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/51 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/25 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/16 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/66 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/79 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Convulsion
|
2.0%
3/151 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/51 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/25 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/16 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/66 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/79 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Febrile convulsion
|
0.66%
1/151 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/51 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/25 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/16 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/66 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/79 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
1.3%
2/151 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.0%
1/51 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/25 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/16 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/66 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/79 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.66%
1/151 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/51 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/25 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/16 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/66 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/79 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.66%
1/151 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/51 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/25 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.2%
1/16 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/66 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/79 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.00%
0/151 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.0%
1/51 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/25 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/16 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/66 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/79 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
0.00%
0/151 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/51 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.0%
1/25 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/16 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/66 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/79 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/151 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/51 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/25 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.2%
1/16 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/66 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/79 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Herpangina
|
0.00%
0/151 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/51 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/25 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.2%
1/16 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/66 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/79 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/151 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/51 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/25 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.2%
1/16 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/66 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/79 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Breath holding
|
0.00%
0/151 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/51 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/25 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.2%
1/16 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/66 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/79 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Other adverse events
| Measure |
Group 1 (Infant Series)
n=151 participants at risk
Participants 6 weeks to \<10 months of age with 0 prior doses of Prevnar received 3 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series).
|
Group 2 (Infant Series)
n=51 participants at risk
Participants \<12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series)
|
Group 3 (Infant Series)
n=25 participants at risk
Participants \<12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series)
|
Group 1 (Toddler Dose)
n=15 participants at risk
Participants \>12 months of age received a single IM 0.5 mL dose of 13vPnC at least 60 days after last infant dose (toddler dose)
|
Group 2 (Toddler Dose)
n=23 participants at risk
Participants \>12 months of age received a single IM 0.5 mL dose of 13vPnC at least 60 days after last infant dose (toddler dose)
|
Group 3 (Toddler Dose)
n=16 participants at risk
Participants \>12 months of age received a single IM 0.5 mL dose of 13vPnC at least 60 days after last infant dose (toddler dose)
|
Group 4 (2 Catch-Up Doses)
n=66 participants at risk
Participants ≥12 months to \<2 years of age received 2 single IM 0.5 mL doses of 13vPnC at least 60 days apart.
|
Group 5 (1 Catch-Up Dose)
n=79 participants at risk
Participants ≥2 years to \<5 years of age received a single IM 0.5 mL dose of 13vPnC.
|
|---|---|---|---|---|---|---|---|---|
|
General disorders
Pyrexia
|
6.0%
9/151 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
7.8%
4/51 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.0%
1/25 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/16 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/66 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/79 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Injection site erythema
|
0.66%
1/151 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/51 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/25 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/16 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/66 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/79 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Injection site swelling
|
0.66%
1/151 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/51 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/25 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/16 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/66 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/79 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Convulsion
|
0.66%
1/151 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/51 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/25 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/16 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/66 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/79 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Crying
|
0.66%
1/151 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/51 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/25 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/16 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/66 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/79 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/151 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/51 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/25 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/16 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.5%
1/66 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/79 • Randomization to 6 months after last vaccination
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
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